*Click test name for more information including; Specimen Requirements, Storage and Transport, Specimen Rejection Criteria, Turn around Time and CPT codes.

Test Name Methodology Test Description Specimen Requirements Storage and Transport Specimen Rejection Criteria Turn Around Time (TAT) CPT Codes*
Harmony Non-Invasive Prenatal Testing (NIPT) Molecular Genetics

The Harmony Prenatal Test® measures the relative proportion of chromosomes to aid in the assessment of fetal trisomies 21, 18, and 13. Harmony® performs a directed analysis of cell-free DNA (cfDNA) in maternal blood and incorporates the fetal fraction of cfDNA in test results. Test results also incorporate maternal age (or egg donor age) and gestational age related probability based on information provided on the test requisition form.

Whole blood specimens.
Acceptable specimen collection/transport containers are:
•Proprietary K3EDTA Cell-Free DNA collection tube - 8.5 ml nominal liquid capacity - minimum volume 1 mL

Specimens are to be shipped with a gel pack at 15° C - 30° C. Specimens are be stored at 18° C -25° C. Viability after transfer to collection/transfer tube is 5 days. Shelf life for the Harmony kit is 18 months.

Click here to reference the specimen rejection criteria.

5-10 Days

81507

PIK3CA Mutation Analysis Molecular Genetics

The PIK3CA Mutation Analysis assay uses next-generation sequencing (NGS) technology to provide an assessment of the PIK3CA gene in select regions of exons 10 and 21 in human genomic DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7-10 Days

81404

PDGFRa Mutation Analysis  Molecular Genetics

The PDGFRA Mutation Analysis assay uses next-generation sequencing (NGS) technology to provide an assessment of the PDGFRA gene for the detection of genetic alterations within select regions of exons 12, 14, and 18 in human genomic DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7-10 Days

81314

NRAS Mutation Analysis Molecular Genetics

The NRAS Mutation Analysis assay uses next-generation sequencing (NGS) technology to provide an assessment of the NRAS gene for the detection of genetic alterations within select regions of exons 2, 3, and 4 in human genomic DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7-10 Days

81311

KIT Mutation Analysis (FFPE Solid Tumor) Molecular Genetics

The KIT Mutation Analysis (Solid Tumor FFPE) assay uses next-generation sequencing (NGS) technology to provide an assessment of the KIT gene for the detection of genetic alterations with select regions of exons 8, 9, 10 11, 13, 14, 17, and 18 in human genomic DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7-10 Days

81272

KIT Mutation Analysis (Bone marrow and peripheral blood) Molecular Genetics

The KIT Mutation Analysis (Blood and Bone Marrow) assay uses targeted next-generation sequencing (NGS) technology to analyze relevant genomic DNA that has been isolated from bone marrow and peripheral blood for mutations in exons 2, 8-11, 13, and 17 of the KIT gene to aid in the diagnosis and prognosis of patients with suspected melanoma or gastric cancer.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

7-10 Days

81272

JAK2 Exons 12 &14 Mutation Analysis Molecular Genetics

The JAK2 Exon 12 & 14 Mutation Analysis assay uses next-generation sequencing (NGS) technology to provide an assessment of the JAK2 gene for the detection of mutations within select regions of exons 12 and 14 in DNA extracted from whole blood and bone marrow with known involvement in myeloproliferative neoplasms (MPN).

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

7-10 Days

81270, 81403

EGFR Mutation Analysis  Molecular Genetics

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7-10 Days

81235

BRAF Mutation Analysis (Blood and Bone Marrow) Molecular Genetics

The BRAF Mutation Analysis (Blood and Bone Marrow) assay uses next-generation sequencing (NGS) technology to provide an assessment of the BRAF gene for the detection of genetic alterations within exon 15 to aid in the diagnosis and prognosis of patients with Hairy Cell Leukemia.

Click here to reference the specimen rejection criteria.

BRAF Mutation Analysis (Solid Tumor) Molecular Genetics

The BRAF Mutation Analysis (Solid Tumor FFPE) assay test uses next-generation sequencing (NGS) technology to provide an assessment of the BRAF gene for the detection of genetic alterations within select regions of exon 15.

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.

Click here to reference the specimen rejection criteria.

7-10 Days

81210

KRAS Mutation Analysis (NGS) Molecular Genetics

The KRAS Mutation Analysis (Solid Tumor FFPE) assay uses next-generation sequencing (NGS) technology to provide an assessment of the KRAS gene for the detection of genetic alterations within select regions of exons 2, 3, and 4 in human genomic DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue. 

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

24 hours

7-10 Days

Targeted Solid Tumor Sequencing Panel Molecular Genetics

The Targeted Solid Tumor Sequencing Panel utilizes the Illumina TruSight Tumor 15 (TST15) assay which is a targeted cancer gene panel dedicated to detecting variants by covering the implicated coding regions of 15 genes associated with solid tumors. TST15 uses next-generation sequencing (NGS) technology to provide a comprehensive assessment of the most commonly mutated genes in 7 cancer types (Lung, Melanoma, Breast, Colon, Ovarian, Gastric, and Prostate). It detects low-frequency variants down to a 5% minor allele frequency (MAF) and requires only 20 ng of DNA isolated from FFPE tumor tissue. TST15 allows for parallel sequencing of multiple cancer-related genes without the need to perform several sequential tests.

FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping.

Click here to reference the specimen rejection criteria.

24 hours

81445

CLL Prognostic Sequencing Panel Molecular Genetics

The CLL Prognostic Sequencing Panel uses NGS technology to provide an assessment of 4 genes (MYD88, SF3B1, TP53, NOTCH1) in one assay. The panel targets mutations with known involvement in the prognosis of patients diagnosed with chronic lymphocytic leukemia (CLL).

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

7-10 Days

81404, 81479(x3)

Comprehensive Myeloid Sequencing Panel Molecular Genetics

The TruSight Myeloid Sequencing Panel uses next-generation sequencing (NGS) technology to provide a comprehensive assessment of 54 genes (tumor suppressor genes and oncogenic hotspots) to target mutations with known involvement in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), chronic myelogenous leukemia (CML), chronic myelomonocytic leukemia (CMML), and juvenile myelomonocytic leukemia (JMML).

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

7-10 Days

81455

UroVysion Bladder Cancer FISH FISH

Cytogenetic studies reveal frequent alterations of a variety of chromosomes associated with bladder carcinoma including chromosomes 1, 3, ,5, 7, 9, 10, 17, and others. The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Voided urine mixed 2:1 (v:v) with recommended PreservCyt (Hologic) or NuCyte fixative.

Specimen should be stored and transported refrigerated with a cool pack.

Click here to reference the specimen rejection criteria.

3 - 5 Days

88120

FITE Special Stains

FITE stains is used to detect M. leprae (leprosy) and Rhodococcus; it combines peanut oil with xylene to minimize exposure of bacteria cell wall to organic solvents and protect precarious acid-fastness of organism.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2- 3 Days

88313

Feulgen Special Stains

Feulgen stain is a staining technique discovered by Robert Feulgen and used in histology to identify chromosomal material or DNA in cell specimens. Schiff’s aldehyde reagent is the stain used. The great value of the Feulgen procedure is the manner in which cells are pretreated so that DNA furnishes the only available aldehyde to react with Schiff’s reagent.

40 cc freshly collected urine mixed with an equal volume of PreservCyt Solution. Please indicate source urine: voided, catherized or bladder washing or one (1) unstained cytology slide prepared by cellular enhancement technique.

Store PreservCyt® Solution or NuCyte Solution with urine specimen between 4°C and 30°C. Process sample within 48 hours.

Click here to reference the specimen rejection criteria.

2-3 Days

88313

TELOMERASE IHC

The biomarker telomerase has been shown to be upregulated in human epithelial cancers, and in bladder cancers. A key component of telomerase is a protein called human telomerase reverse transcriptase (hTERT), which can be recognised in cytological specimens by Anti-hTERT Antibody (SCD-A7) using immunocytochemistry (ICC). Specifically, the presence of hTERT in urothelial cells shed from the bladder wall into urine, can be detected in this way. A positive test for hTERT in urothelial cells indicates an altered process of some kind, and since 90% of bladder cancers upregulate telomerase, it indicates an increased chance that cancer is present.

40 cc freshly collected urine mixed with an equal volume of PreservCyt Solution. Please indicate source urine: voided, catherized or bladder washing or one (1) unstained cytology slide prepared by cellular enhancement technique.

Store PreservCyt® Solution or NuCyte Solution with urine specimen between 4°C and 30°C. Process sample within 48 hours.

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

SOX 10 IHC

SOX-10 is a transcription factor known to be crucial in the specification of the neural crest and maintenance of Schwann cells and melanocytes.  It is expressed in nuclei of melanocytes, breast myoepithelial cells.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

SMM-HC IHC

SMM-HC stands for smooth muscle myosin heavy chain. It is expressed in the cytoplasm and cell membrane of myoepthelial and smooth muscle cells. It is useful for the differentiation of benign and malignant breast and lung (bronchoalveolar carcinoma) lesions.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

QuadVysion IHC

This test uses a combination of several antibodies (applied to a single slide) that differentially stain for basal cells and neoplastic cells in the prostate: P504S stains prostate adenocarcinoma, whereas p63 and the high molecular weight cytokeratins stain benign prostate basal epithelial tissue. These are combined with C-MYC, a proto-oncogene. C-MYC is amplified in 20-30% of breast cancer cases; associated with HER2 amplification and poor outcome. C-MYC expression in primary prostate tumor is biologically relevant and may be a predictor of future biochemical recurrence. This combination may help differentiate prostate cancer from precancerous lesions such as prostatic intraepithelial neoplasia (PIN), especially when tissue is limited.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88344

PSMA IHC

PSMA stands for prostate specific membrane antigen. Staining is expressed in high grade prostatic adenocarcinoma, in contrast to PSA. It is associated with high Gleason score.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PSAP IHC

PSAP is prostatic specific acid phosphatase which is an enzyme produced by prostate tissue. Positive staining identifies malignancies of prostatic origin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PCNA IHC

P27 is a cyclin dependent kinase inhibitor leading to cell cycle arrest in G1 phase. Loss or reduced expression is associated with poor outcome in carcinoma of breast, prostate, GI tract and lung.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PIN-4 IHC

This test uses a combination of several antibodies (applied to a single slide) that differentially stain for basal cells and neoplastic cells in the prostate: P504S stains prostate adenocarcinoma, whereas p63 and the high molecular weight cytokeratins stain benign prostate basal epithelial tissue. This combination may help differentiate prostate cancer from precancerous lesions such as prostatic intraepithelial neoplasia (PIN), especially when tissue is limited.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88344

p27 IHC

P27 is a cyclin dependent kinase inhibitor leading to cell cycle arrest in G1 phase. Loss or reduced expression is associated with poor outcome in carcinoma of breast, prostate, GI tract and lung.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

GATA3 IHC

GATA3 is involved in the luminal differentiation of breast epithelium; also master regulator of type 2 helper T cells. GATA3 is a nuclear marker with expression in many epithelial neoplasms (including most breast, urothelial and skin carcinoma; smaller percentages of lung, liver, pancreatic, gastric, renal, thyroid, endometrial, ovarian and salivary gland carcinoma).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

FGFR3 IHC

FGFR3 is a member of receptor tyrosine kinase family that controls cell proliferation, differentiation, survival. FGFR3 is mutated in urothelial carcinoma (84% of low grade, 17% of high grade) and low grade prostatic adenocarcinoma. Also staining is positive in urothelial papillomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

ERG IHC

ERG immunohistochemistry (nuclear stain) accurately assesses presence of TMPRSS2-ERG fusion protein. Staining of atypical focus is specific for prostatic carcinoma if high-grade PIN can be excluded.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

E-Cadherin IHC

E-cadherin is a calcium dependent transmembrane epithelial protein that promotes intercellular adhesion. E-cadherin can distinguish breast LCIS from DCIS in indeterminate cases. In addition, there is reduced expression in urothelial cancer and absent in gastric signet ring cell carcinoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

C-MYC IHC

C-MYC is a proto-oncogene at 8q24.1 produces short lived nuclear phosphoprotein that is overexpressed by t(8;14)(q24;q32.3), t(8;22);(q24;11) and t(2;8);(p11-12;q24), which translocate c-myc gene next to immunoglobulin genes in Burkitt’s lymphoma. C-MYC is amplified in 20-30% of breast cancer cases; associated with HER2 amplification and poor outcome. C-MYC expression in primary prostate tumor is biologically relevant and may be a predictor of future biochemical recurrence.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Calponin IHC

Calponin is an actin filament associated regulatory protein. Commonly used to identify myoepithelial cells in breast lesions. It can also help differentiate breast collagenous spherulosis (positive) from adenoid cystic carcinoma (negative).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Adipophilin IHC

Adipophilin is an antibody against a protein on the surface of intracellular lipid droplets, and it was recently shown to be expressed in sebocytes and sebaceous lesions. Adipophilin can be valuable in an immunohistochemical panel when evaluating cutaneous lesions with clear cell histology as it identifies intracytoplasmic lipid vesicles in sebaceous and xanthomatous lesions. It is effective in helping to exclude basal cell carcinoma and squamous cell carcinoma when sebaceous carcinoma is under consideration.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Respiratory Pathogen Panel (RPP) Molecular Genetics

Multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of mulitple viral and bacterial nucleic acids in nasopharyngeal swab specimens from individuals with signs and symptons of upper respiratory tract infection.

Nasopharyngeal Swab collected and transported in Viral Transport Media

Nasopharyngeal swab specimens should be collected and transported in Viral Transport Media. Specimens should refrigerated until shipping. Use cold packs and ship in insulated foam container. Specimens must be maintained at 2-8 degrees C.

Click here to reference the specimen rejection criteria.

3 Days

87633, 87798, 87486, 87581

PDGFRβ FISH

•Disease(s): Myeloid neoplasms associated with eosinophilia
•Probes:
◦PDGFRB (5q32)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

Herpes Simplex Virus Type 1/2 DNA

This assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Herpes Symplex Virus 1 and Herpes Simplex Virus 2 genome in symptomatic patients.

Acceptable specimen collection/transport containers are:
• SimpleSwab™
• BD eSwab
• Viral Transport Media

Specimens can be shipped and stored at 2 - 24°C. If shipping temperatures exceeding 24°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•SimpleSwab™: 15 Days
•BD eSwab: 15 Days
•Viral Transport Media: 15 Days

Click here to reference the specimen rejection criteria.

1 - 2 Days

87529(x2)

CF60 Cystic Fibrosis Carrier Screen PCR

The Luminex xTAG Cystic Fibrosis 60 v2 (CF 60 panel) is an FDA-cleared device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance (CFTR) gene in human blood specimens. The mutations analyzed include: dF508, dI507, G542X, G85E, R117H, 621+1G>T, 711+1G>T, N1303K, R334W, R347P, A455E, 1717-1G>A, R560T, R553X, G551D, 1898+1G>A, 2184delA, 2789+5G>A, 3120+1G>A, R1162X, 3659delC, 3849+10kbC>T, W1282X, 1078delT, 394delTT, Y122X, R347H, V520F, A559T, S549R(T>G), S549N, 1898+5G>T, 2183AA>G, 2307insA, Y1092XC>A, Y1092XC>G, M1101K, S1255X(ex.19), S1255X(ex.20), 3876delA, 3905insT, CFTR dele2,3, E60X, R75X, 406-1G>A, G178R, L206W, 935delA, G330X, Q493X, 1677delTA, 2055del9>A, 2143delT, K710X, Q890X, 3199del6, R1066C, W1089X, D1152H, R1158X, 3791delC, S1196X, 5T, 7T, 9T, F508C, 1507V (1651A/G), and I506V.

Whole blood specimens. Acceptable specimen collection/transport containers are:
•EDTA - minimum volume 1 mL

Specimens can be shipped with cool pack and stored at 2 - 8°C. Viability after transfer to collection/transport tube is:
•EDTA: 5 Days

Click here to reference the specimen rejection criteria.

3 - 5 Days

81220

Mycoplasma genitalium PCR

This assay utilizes DNA extraction followed by multiplex PCR and automated microcapillary electrophoresis for the detection and identification of Mycoplasma genitalium.

Cervical or vaginal swab collections. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• SurePath™ Pap Vial
Please clearly label vaginal swab collections into a ThinPrep® or SurePath™ Pap Vial as VAGINAL.

Specimens can be shipped and stored at 2 - 24°C. If shipping temperatures exceeding 24°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 21 Days
• SurePath™ Pap Vial: 21 Days
• SimpleSwab™: 5 Days
• BD eSwab: 5 Days

Click here to reference the specimen rejection criteria.

3 - 5 Days

87798

Atopobium vaginae PCR

This assay utilizes DNA extraction followed by multiplex PCR and automated microcapillary electrophoresis for the detection and identification of Atopobium vaginae.

Cervical or vaginal swab collections. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
•SurePath™ Pap Vial
Please clearly label vaginal swab collections into a ThinPrep® or SurePath™ Pap Vial as VAGINAL.

Specimens can be shipped and stored at 2 - 24°C. If shipping temperatures exceeding 24°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 21 Days
• SurePath™ Pap Vial: 21 Days
• SimpleSwab™: 5 Days
• BD eSwab: 5 Days

Click here to reference the specimen rejection criteria.

3 - 5 Days

87798

Herpes Simplex Virus Type 1/2 PCR

This assay utilizes DNA extraction followed by multiplex PCR and automated microcapillary electrophoresis for the detection and identification of Herpes Simplex Virus Type 1/2.

Cervical or vaginal swab collections. Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• SurePath™ Pap Vial

Please clearly label vaginal swab collections into a ThinPrep® or SurePath™ Pap Vial as VAGINAL.

Specimens can be shipped and stored at 2 - 24°C. If shipping temperatures exceeding 24°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 28 Days
• SurePath™ Pap Vial: 28 Days
• SimpleSwab™: 15 Days
• BD eSwab: 15 Days

Click here to reference the specimen rejection criteria.

3 - 5 Days

87529(x2)

Trichomonas RNA - Hologic Panther

This assay is a qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis.

Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• APTIMA® Specimen Transfer Tube containing 1 ml of ThinPrep® or SurePath™ Pap Vial contents (vortex vial before transfer)
• APTIMA® Unisex Swab
• APTIMA® Vaginal Swab

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 30 days
• APTIMA® Specimen Transfer Tube: 14 days containing SurePath™ aliquot, 30 days containing ThinPrep® aliquot
• APTIMA® Unisex Swab: 30 days
• APTIMA® Vaginal Swab: 30 days
• SimpleSwab™: 12 Days
• BD eSwab: 12 Days

Click here to reference the specimen rejection criteria.

2 - 4 Days

87661

HPV High Risk DNA - Roche Cobas

This assay utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 66, and 68). HPV High Risk test are performed and reported in conjunction with HPV 16, 18, and other 12-pooled genotypes.

Cervical Specimens. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days

Click here to reference the specimen rejection criteria.

2-4 Days

87624

HPV High Risk RNA - Hologic Panther

This assay is a nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This assay does not discriminate between the types. Studies show that targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection. Testing is available with reflex to HPV Genotyping when positive.

Cervical Specimens. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
•APTIMA® Specimen Transfer Tube containing 1 ml of ThinPrep® or SurePath™ Pap Vial contents (vortex vial before transfer)

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days
•APTIMA® Specimen Transfer Tube: 30 days containing ThinPrep® aliquot

Click here to reference the specimen rejection criteria.

2 - 4 Days

87624

HPV Genotyping 16, 18, other 12-pooled DNA - Roche Cobas

This assay utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 66, and 68). HPV 16, 18, other 12-pooled genotypes test are performed and reported in conjunction with HPV High Risk.

Cervical Specimens. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days

Click here to reference the specimen rejection criteria.

2-4 Days

87624

HPV Genotyping 16, 18/45 RNA - Hologic Panther

This assay is a nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) in cervical specimens from women with HPV+ results. This test can differentiate HPV 16 from HPV 18 and/or 45, but not between HPV 18 and 45. Studies show that targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection.

Cervical Specimens. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
•APTIMA® Specimen Transfer Tube containing 1 ml of ThinPrep® or SurePath™ Pap Vial contents (vortex vial before transfer)

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days
•APTIMA® Specimen Transfer Tube: 30 days containing ThinPrep® aliquot

Click here to reference the specimen rejection criteria.

2 - 4 Days

87625 (add 87624 when reflexed from HPV High Risk)

Gonorrhea DNA - Roche Cobas

This assay is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Neisseria gonorrhea (NG). Testing is also available in combination with Chlamydia.

Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• COBAS® PCR Female Swab Sample Kit
• COBAS® PCR Urine Sample Kit"

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 30 days
• COBAS® PCR Female Swab Sample Kit: 30 days
• COBAS® PCR Urine Sample Kit: 30 days
• SimpleSwab™: 10 Days
• BD eSwab: 10 Days

Click here to reference the specimen rejection criteria.

2 - 4 Days

87591

Gonorrhea RNA - Hologic Panther

This assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhea (NG). Testing is also available in combination with Chlamydia detection.

Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• APTIMA® Specimen Transfer Tube containing 1 mL of ThinPrep® or SurePath™ Pap Vial contents (vortex vial before transfer)
• APTIMA® Unisex Swab
• APTIMA® Vaginal Swab
• APTIMA® Urine Transport Tube

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days
•APTIMA® Specimen Transfer Tube: 14 days containing SurePath™ aliquot, 30 days containing ThinPrep® aliquot
•APTIMA® Unisex Swab: 30 days
•APTIMA® Vaginal Swab: 30 days
•APTIMA® Urine Transport Tube: 30 days
• SimpleSwab™: 10 Days
• BD eSwab: 10 Days

Click here to reference the specimen rejection criteria.

2 - 4 Days

87591

xTAG GPP Molecular Genetics

Multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of mulitple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptons of infectious colitis or gastroenteritis.

Human Stool

Stool specimens should be collected as soon after onset of symptons as possible. Fresh stool specimens should be placed in provided collection xTAG GPP colelction tube.

Click here to reference the specimen rejection criteria.

3 Days

87493, 87798, 87502, 87505, 87506, 87507

T-Cell Gene Rearrangement  Molecular Genetics

Detection of clonal T-cell receptor gamma gene rearrangements by PCR of variable and joining regions.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fresh tissue: Two pieces minimum, 0.2 cm3 in RPMI.

Refrigerate fresh tissue until shipping. For all specimens, use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81342

PML-RARA Translocation, t(15;17) Molecular Genetics

Real-time RT-PCR for quantitative detection of the t(15;17) PML-RARA fusion transcript. Both long and short isoforms of the fusion transcript are detected. Positive results identify the isoform and quantify it as a ratio with the amount of transcript from a normal control gene. Analytical sensitivity is 1 tumor cell in 100,000 normal cells.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

5-7 Days

81315

PDGFRa Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exons 12 and 18 of the PDGFRA (platelet-derived growth factor alpha) gene. These exons are mutation hotspots that account for the majority of PDGFRA mutations detected in gastrointestinal stromal tumors (GISTs) including the common TKI-resistance mutation D842V. Solid tumor enrichment is performed before extraction.

FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transporting block during summer to prevent block from melting. Slides can be packed at room temperature.

Click here to reference the specimen rejection criteria.

7 Days

81404

NPM1 Mutation Analysis  Molecular Genetics

PCR and fragment analysis of exon 12 of the NPM1 gene to detect small insertion mutations specific to AML. Positive results are reported quantitatively as percent abnormal DNA. Testing may be performed on plasma to increase sensitivity.  

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81310

MPN Extended Reflex Panel   Molecular Genetics

Sequential testing panel including analysis of JAK2 V617F, JAK2 Exon 12-14, CALR exon 9, and MPL exon 10. Testing proceeds by reflex through the four-step panel until a mutation is identified, when the result is considered informative and no further testing is performed. Testing is performed on plasma for increased sensitivity whenever possible. Tests may also be ordered individually or as a three-step reflex panel without CALR in the MPN Standard Reflex Panel (see separate listing). 

•Peripheral blood: 4 mL in EDTA tube. •Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

10 Days

81270, 81402, 81403, 81479

MPL Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exon 10 of the MPL gene to detect all possible mutations at the W515 and S505 codons, and other mutations throughout the exon. Testing is performed on plasma for increased sensitivity whenever possible. This test may be ordered separately or as part of the MPN Reflex Panel.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

7 Days

81402

Microsatellite Instability Analysis (MSI) Molecular Genetics

PCR and fragment analysis of paired normal and tumor tissue to determine microsatellite instability (MSI) at the standard five NCI-recommended loci. Positive results are reported as MSI-high (at least two markers are unstable) or MSI-low (one marker is unstable).

•Note: An additional patient sample from normal, non-tumor tissue is required for comparison testing in MSI Analysis. Please submit all specimens with one test requisition form.
•Specimen requirements for normal tissue in order of preference are: 1) 5 mL peripheral blood in EDTA tube OR 2) FFPE tissue slides or block containing only non-tumor tissue. Please label these as ""normal tissue"". OR 3) In cases where no alternative tissue is available, we can attempt to isolate non-tumor tissue from the tumor specimen submitted. Note “Use tumor sample for normal tissue” on requisition. See requirements below.
•Specimen requirements for tumor tissue: FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81301

KRAS Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exons 2 and 3 of the KRAS gene, which includes detection of mutations in codons 12, 13, 59, and 61.  Tumor enrichment is performed before extraction. 

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fine needle aspirate (FNA): Requisition must note specimen is FNA. Fresh cells in suspension, unstained air-dried smears (approx. 6-8 slides), or FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81275

KRAS Exon 4 Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exon 4 of the KRAS gene corresponding to amino acids R97 through Q150. Codon 117 and 146 mutations are detected. For solid tumors, tumor enrichment is performed before extraction. This test may be ordered separately or by reflex after standard KRAS Mutation Analysis. 

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fine needle aspirate (FNA): Requisition must note specimen is FNA. Fresh cells in suspension, unstained air-dried smears (approx. 6-8 slides), or FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81479

KRAS & BRAF Mutation Analysis  Molecular Genetics

Concurrent analysis of KRAS and BRAF gene regions including KRAS exons 2 and 3 (with mutation detection in codons 12, 13, 59, and 61) and BRAF exon 15 to detect V600 mutations and more. Tumor enrichment is performed before extraction.

FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Use cold pack for transporting block during summer to prevent block from melting. Slides can be packed at room temperature.

Click here to reference the specimen rejection criteria.

7 Days

81210, 81275

JAK2 V617F Mutation Analysis  Molecular Genetics

Detects the V617F mutation. The rare mutation V617I is also detected. Testing is performed on plasma for increased sensitivity whenever possible. V617F testing may be ordered separately, concurrently with full exon 12-14 sequencing, with reflex to exon 12-14 sequencing, or as part of the MPN Reflex Panel.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

5 Days

JAK2 V617F Only: 81270 JAK2 V617F and EXON 12-14 run concurrently or by reflex:  81270, 81403

JAK2 Exon 12-14 Mutation Analysis   Molecular Genetics

RT-PCR and bi-directional sequencing to detect non-V617F mutations in exons 12-14 and most of exon 15, corresponding to the majority of the JAK2 pseudokinase domain. Exon deletion mutations are detectable. Testing is performed on plasma for increased sensitivity whenever possible. V617F analysis is recommended before or concurrently with this test. Exon 12-14 Mutation Analysis may be ordered separately, with concurrent V617F testing, by reflex after negative V617F testing, or as part of the MPN Reflex Panel.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

5 Days

JAK2 Exon 12-14 Only: 81403 JAK2 V617F and EXON 12-14 run concurrently or by reflex:  81270, 81403

IgVH Mutation Analysis  Molecular Genetics

RT-PCR and bi-directional sequencing of the variable region of the immunoglobulin heavy chain for detection of mutation from germline sequence. The mutated VH gene family is identified in positive reports (>3% sequence deviation). Mutation may not be detectable in specimens containing <10% clonal B-cells.  

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

10 Days

81263

FLT3 Mutation Analysis  Molecular Genetics

Detection of internal tandem duplication and exon 20 tyrosine kinase domain (TKD) mutations using bi-directional sequencing. Positive results identify specific TKD mutations or report ITD results quantitatively as percent abnormal ITD peak. Testing may be performed on plasma to increase sensitivity.  

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81245, 81246

EGFR Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exons 18-21 of the EGFR gene for detection of EGFR-activating mutations and TKI resistance mutations in these exons. Tumor enrichment is performed before extraction. 

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fine needle aspirate (FNA): Requisition must note specimen is FNA. Fresh cells in suspension, unstained air-dried smears (approx. 6-8 slides), or FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81235

c-KIT (KIT) Mutation Analysis Molecular Genetics

Bi-directional sequencing of KIT exons 8, 9, 11, and 17 for detection of activating mutations including the common mutation D816V. For solid tumors, tumor enrichment is performed before extraction. In hematological disease, testing may be performed on plasma to increase sensitivity.  

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fixed cytogenetic cell pellet: Send all available cells suspended in fixative.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.  

Click here to reference the specimen rejection criteria.

7 Days

81404

CEBPA Mutation Analysis  Molecular Genetics

Bi-directional sequencing of the relevant coding region and fragment analysis for detection of sequence variant and internal tandem duplication mutations. The SNP genotype at rs34529039 is reported. Testing is performed on plasma for increased sensitivity whenever possible.  

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81403

CBL Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exons 8 and 9 of the CBL gene.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81479

CALR Mutation Analysis Molecular Genetics

Bi-directional sequencing of exon 9 of the CALR (calreticulin) gene with fragment length analysis for enhanced detection of low levels of insertion/deletion mutations.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

5-7 Days

81479

BRAF Mutation Analysis  Molecular Genetics

Bi-directional sequencing of exon 15 of the BRAF gene, which includes qualitative detection of V600 mutations E, K, D, and others, plus other significant exon 15 mutations. For solid tumors, tumor enrichment is performed before extraction.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fine needle aspirate (FNA): Requisition must note specimen is FNA. Fresh cells in suspension, unstained air-dried smears (approx. 6-8 slides), or FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature

Click here to reference the specimen rejection criteria.

7 Days

81210

BCR-ABL1 Translocation, t(9;22) – quantitative  Molecular Genetics

Real-time RT-PCR for detection of t(9;22) BCR-ABL1 fusion transcripts that result in p190 (E1) or p210 (E13, E14) fusion proteins. Analytical sensitivity is 1 tumor cell in 100,000 normal cells. Log reduction score is reported. Longitudinal data will appear as a NeoTRACK Result on the report. 

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

5-7 Days

81206, 81207

BCL1 Translocation, t(11;14) Molecular Genetics

Real-time PCR for quantitative detection of t(11;14) BCL1/IgH rearrangements. Analytical sensitivity is approximately 1 tumor cell in 1000 normal cells. Positive results are reported as a ratio between quantities of (11;14) DNA and a normal control gene. This translocation is also known as CCND1/IgH or BCL1/JH.

"•Peripheral blood: 4 mL in EDTA tube. •Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
"

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

5-7 Days

81401

B-Cell Gene Rearrangement Molecular Genetics

Detection of clonal IgH and Ig kappa gene rearragements by PCR of IgH framework regions 1, 2, 3 and joining regions, Ig kappa FR3 and Jk regions.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fresh tissue: Two pieces minimum, 0.2 cm3 in RPMI.

Refrigerate fresh tissue until shipping. For all specimens, use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81479(x2)

B-Cell & T-Cell Gene Rearrangement  Molecular Genetics

PCR for detection of clonal IgH, Ig kappa, and T cell receptor gene gamma gene rearragements.

•Peripheral blood: 4 mL in EDTA tube.
•Bone marrow: 2 mL in EDTA tube.
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
•Fresh tissue: Two pieces minimum, 0.2 cm3 in RPMI.

Refrigerate fresh tissue until shipping. For all specimens, use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

7 Days

81402, 81479(x2)

PCA3 (Prostate Cancer Antigen 3) Transcription Mediated Amplification (TMA) and Hybrid Protection Assay (HPA)

Adjunct to serum PSA for risk stratification of patients undergoing repeat prostate biopsy. The PCA3 test is a molecular assay that detects the mRNA expression of the DD3 gene expressed in prostate cells. In recent studies it was shown to have a specificity of 78% and a sensitivity of 57% in cancer vs. non-cancer.

PROGENSA PCA3 Urine Specimen Transport Tubes required for processing.

Perform an attentive DRE immediately prior to specimen collection (the specimen should be collected within approximately 1 hour of DRE). Instruct patient to collect the FIRST 20 - 30 mL of voided urine following the DRE. Process the specimen as follows within 4 hours of collection (if specimen cannot be processed within 15 minutes, store refrigerated or on ice): 1) Invert specimen cup 5 times to re-suspend cells. 2) Add 2.5 mL of urine to each of two GEN-PROBE PROGENSA PCA3 Urine Specimen Transport Tubes. Do NOT puncture the foil seal on the cap of the Transport Tube. The specimen volume should fall between the two black fill lines on the Transport Tube. 3) Tightly re-cap each Urine Transport Tube and gently invert 5 times to mix. The specimen is now a "processed" urine specimen. Refrigerate. Refrigerated specimens must be received by Lab within 4 days of collection. For longer storage, freeze and ship specimen on dry ice. Include serum PSA result and patient history with the specimen.

Click here to reference the specimen rejection criteria.

5 - 8 Days

81313

Warthin Starry Special Stains

Warthin-Starry Stain Kit is used to identify Helicobacter pylori, spirochetes and other microorganisms in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. H. pylori and spirochetes are stained black while the background is stained golden yellow.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88312

Retic Special Stains

Reticulin/Nuclear Fast Stain Kit is used to identify a primitive form of connective tissue, called reticulin, in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. An Ammoniacal Silver Nitrate solution is applied to stain the reticulin fibers in tissue. The silver is then reduced and toned to produce a black coloration of the fibers, which are visible by light microscopy. Other tissue elements will be stained pink

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

AB/PAS/H Special Stains

Alcian Blue/PAS/Hematoxylin Stain Kit is intended to identify acidic and neutral mucins in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. This procedure clearly separates the acidic and neutral mucins by color and can be used to distinguish all mucins in tissue sections. Alcian Blue pH 2.5 stains the acid mucin blue while the Schiff’s reagent stains the neutral mucins pink to red. Mixtures of the two mucins will appear purple due to the positive reactions with both Alcian Blue and Schiff’s reagent. A hematoxylin counterstain is then applied to impart a blue/black color to the nuclei.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

GMS Special Stains

Grocott’s Methenamine Silver (GMS) Stain Kit is intended to identify fungal organisms and Pneumocystis jiroveci (formerly known as carinii) in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. Fungi and Pneumocystis jiroveci are stained black while other tissue elements are stained green. This stain is not recommended for cytology specimens.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88312

Gram Special Stains

Gram Stain Kit is used to identify two distinct groups of microorganisms in tissue sections on Artisan™ Link and Artisan™ Link Pro Staining Systems. Those that retain primary dye (Crystal Violet) are called Gram-positive. Those that lose the primary dye during decolorization are called Gram-negative. Mechanisms of Gram-positive organisms retaining the primary stain and Gram-negative organisms losing the primary stain are the result of the chemistry and structure of the organism’s cell walls. The tissue elements are stained as follow: Gram-positive organisms: blue, Gram-negative organisms: red and background: varying shades of blue/green.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88312

Trichrome Masson’s Special Stains

Masson’s Trichrome Stain Kit is used to identify muscle, collagen fibers, fibrin and erythrocytes in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. Masson’s Trichrome is often used to demonstrate increased collagen deposition that is associated with replacement of functional tissue by scar tissue. This is useful in the assessment of sclerosis of the liver in which thickened collagen replaces normal tissue causing liver dysfunction. Muscle: red, collagen: blue, fibrin: pink, erythrocytes: red and nuclei: blue/black.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

PAS-LG Special Stains

PAS-Green Stain Kit is used to identify fungi in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. The most commonly used application is for demonstrating fungi in skin infections. Unlike GMS, the PAS-Green technique will not stain all fungi and yeast. However, fungi typically found in dermatologic specimens are commonly identified using PAS-Green. Positive fungi: magenta and the remaining tissue elements: blue/green.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

AB/PAS Special Stains

Alcian Blue/PAS Stain Kit is intended to identify acidic and neutral mucins in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. This procedure clearly separates the acidic and neutral mucins by color and can be used to distinguish all mucins in tissue sections. Alcian Blue pH 2.5 stains the acid mucin blue while the Schiff’s reagent stains the neutral mucins pink to red. Mixtures of the two mucins will appear purple due to the positive reactions with both Alcian Blue and Schiff’s reagent. This stain can be used with the digestive enzyme, Artisan™ Alpha-Amylase (Code AR171), for the demonstration of glycogen in tissue.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

Mucicarmine Special Stains

Mucicarmine Stain Kit is used to identify epithelial mucins in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. These mucins are a family of polysaccharides covalently linked to proteins in epithelial cells. The mucins: pink, nuclei: black and other tissue elements: yellow.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

PAS Special Stains

PAS Stain Kit is used to identify glycogen in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. PAS-positive entities and structures are also numerous in tissue sections. The most common application is for demonstrating glycogen in the liver. Duplicate sections are stained with or without a pre-treatment, such as the Artisan™ Alpha-Amylase (Code AR171), which is a glycogen-digesting enzyme. Comparing PAS signal intensity in a digested tissue sample with one that has not been digested will give an indication of the amount of glycogen present. A loss of glycogen may be indicative of a metabolic disorder or damage to the liver. Positive glycogen: magenta, nuclei: blue and the background: pink.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

Giemsa Special Stains

Giemsa Stain Kit is typically used to identify hematopoietic cells (i.e. mast cells, basophils, polymorphoncuclear leucocytes, etc.) in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. In tissue specimens it will stain mast cells, which may be useful in the identification of mast cell tumors. Although Giemsa stains are frequently used to study bone marrow specimens as an aid in assessment of blood disorders, this Giemsa Stain Kit is not designed for this application. The tissue elements are stained as follows: Mast cell granules: purple, basophils: purple, eosinophils: bright pink and lymphocytes: blue. This stain is not recommended for cytology specimens or bone marrow smears.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

Elastic Special Stains

Elastic Stain Kit is used to identify elastin fibers in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. This stain utilizes Alcoholic Hematoxylin, Ferric Chloride and Lugol’s Iodine solutions to stain elastin fibers. Van Gieson’s solution is added to differentiate collagen from elastin. Elastin fibers are stained black while remaining tissue elements are stained as follows: nuclei: blue/black, collagen: red, and other tissue elements: yellow.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

AFB Special Stains

Acid-Fast Bacillus (AFB) Stain Kit is intended to identify acid-fast bacteria, such as Mycobacterium , in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. Application of Carbol Fuchsin stains acid-fast bacteria red, followed by decolorization of all tissue elements except the acid-fast bacteria. A Methylene Blue counterstain is then applied to impart a blue color to all background tissue elements.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88312

Congo Red Special Stains

Congo Red Stain Kit is used to identify amyloid in tissue sections on Artisan™ Link and Artisan™ Link Pro Staining Systems. Amyloid is an abnormal protein product that can be found in various pathologic conditions. This stain demonstrates amyloid in pink to dark pink with light (bright field) microscopy or the characteristic apple green bi-refringence with polarized light. Mayer’s Hematoxylin is used as a counterstain. This stain has been optimized with 8 µm thick tissue sections.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

AB 2.5 Special Stains

Alcian Blue pH 2.5 Stain Kit is intended to identify weakly sulfated mucins in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. At pH 2.5, acidic mucopolysaccharides stains blue. A Nuclear Fast Red counterstain will stain the nuclei red to pink and all other tissue elements a pale pink.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

P16 KIT IHC

CINtec® p16 (E6H4) immunohistochemistry detects the over-expression of the cellular protein p16INK4a in cervical tissue and cytology specimens correlated with hrHPV-mediated oncogenic transformation.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CAM 5.2 IHC

Cytokeratins are polypeptide chains that form structural proteins within the epithelial cell cytoskeleton. Nineteen different molecular forms of cytokeratin have been identified in both normal and malignant epithelial cell lines.1 Because specific combinations of cytokeratin peptides are associated with different epithelial cells, these peptides are clinically important markers for classifying carcinomas (tumors of epithelial origin)2 and for distinguishing carcinomas from malignant tumors of nonepithelial origin such as lymphomas, melanomas, and sarcomas. The identification of cytokeratin has gained increasing importance in immunopathology. A scheme for the use of anti-cytokeratin in the classification of tumors is presented in the current Manual of Clinical Laboratory Immunology, Chapter 145.5.3

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

TREPONEMA PALLIDUM IHC

Spirochete (Treponema pallidum) is the causative agent of syphilis. In the past, localization of the spirochete agent was achieved with silver stains such as Steiner’s and/or Warthin-Starry. Treponema pallidum can now be successfully localized with immunohistochemical techniques in formalin-fixed paraffinembedded tissue. Studies have shown this offers a substantial advantage over silver-techniques in both sensitivity and specificity. The antibody consists of a rabbit purified IgG fraction and is highly specific for spirochete (1).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PAN MEL COCKTAIL IHC

MART-1 recognizes a protein of 18 kDa, identified at MART-1 (Melanoma Antigen Recognized by T cells 1). MART-1 is a useful addition to melanoma panels as it is apparently specific for melanocytic lesions (1,4). Studies have shown that MART-1 is more sensitive than HMB45 when labeling metastatic melanomas (3). This MART-1 cocktail does not stain steroid tumors like Melan A [103] does. Tyrosinase is a key enzyme involved in the initial stages of melanin biosynthesis. Studies have shown Tyrosinase to be a more sensitive marker when compared to HMB45 and MART-1. It has also been shown to label a higher percentage of desmoplastic melanomas than HMB45 (1). The combination of MART-1 and Tyrosinase aids in identifying metastatic melanoma in sentinel lymph nodes (2).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

P63 IHC

p63, a homolog of the tumor suppressor p53, has been identified in basal cells in the epithelial layers of a variety of tissues, including epidermis, cervix, urothelium, breast and prostate (1). p63 was detected in nuclei of the basal epithelium in normal prostate glands; however, it was not expressed in malignant tumors of the prostate (2). As a result, p63 has been reported as a useful marker for differentiating benign from malignant lesions in the prostate, particularly when used in combination with markers of high molecular weight cytokeratins and the prostate-specific marker AMACR (P504S) (3-4).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

HSV 1 & 2 IHC

This antibody reacts with Herpes Simplex Virus (HSV) 1 and 2. It reacts with major viral envelope glycoproteins and with core proteins. Infected biopsy tissues include esophagus, lung, liver, cervix and perianal region, as well as cytology specimens. HSV can also infect both the peripheral and central nervous system. Viral antigens may be detected in the cytoplasm and nucleus. Typically, HSV Type 1 infects tissues such as lung and esophagus and HSV Type 2 infects the genitals and anus. This antibody does not cross-react with cytomegalovirus, Epstein-Barr virus, or varicella zoster virus. This antibody is compatible with formalin fixation, however prolonged fixation can be detrimental to HSV staining.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

FACTOR X111A IHC

This is a monoclonal antibody to the A-subunit of human coagulation Factor XIII. Studies have shown it recognizes human Factor XIII A-chain in both reduced and nonreduced forms. It does not react with human Factor XIII B-chain or human Factor XII. Factor XIII is a beta-globulin found in plasma and is composed of two subunits. Factor XIII-A is the catalytic subunit and is a dimer of M.W. 160,000. According to studies, Factor XIII is present in plasma as an alpha2beta2 heterodimer (M.W. 320,000); whereas in platelets, only the alpha2 unit exists. Factor XIIIa is a dermal dendrocyte marker and shows variable reaction with these types of tumors (3,4). It can be used for histiocytic phenotyping and has been reported to mark capillary hemangiomas and tumors of the central nervous system (1-6). Factor XIIIa has also been used with CD34 to differentiate between dermatofibroma and dermatofibrosarcoma protuberans (3).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD71 IHC

CD71 (transferrin receptor) is reported to be expressed on nucleated erythroid precursors, reticulocytes, activated B and T cells, macrophages, normal and neoplastic proliferating cells and metabolically active cells. It is most commonly used to highlight and quantify erythroid precursors in bone marrow samples.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD42B IHC

Immunohistochemical staining for CD42b highlights normal and dysplastic megakaryocytes associated with various subtypes of myeloid neoplasms.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PROCOLLAGEN IHC

ab64409 recognizes Human procollagen I. Labels the amino-terminal pro-peptide. Localized intracellularly in cells producing pro-collagen I. Does not stain mature collagen fibers in tissue.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

TIA-1 IHC

Immunohistochemical staining for TIA-1 detects normal and neoplastic T-cell containing cytotoxic granules. T-cell lymphomas showing TIA-1 expression include anaplastic large cell lymphomas, NK cell lymphomas and peripheral T-cell lymphomas large granular lymphocytic leukemia’s, hepatosplenic T-cell lymphomas, enteropathy-associated T-cell lymphomas, T/NK-cell lymphomas, nasal type, subcutaneous panniculitis-like T-cell lymphomas, pulmonary angiocentric lymphomas of T or NK phenotype.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CHROMAGRANIN IHC

Immunohistochemical methods have localized chromogranin in a wide variety of endocrine tissues such as the pituitary, pancreas, hypothalamus, and parathyroid. Neuroendocrine cells exhibit a fine granular immunoreactivity to anti-chromogranin. It is generally accepted that the co-expression of certain keratins and chromogranin mean neuroendocrine lineage. The presence of strong anti-chromogranin staining and absence of anti-keratin staining should raise the possibility of paraganglioma. The co-expression of chromogranin and NSE is typical of neuroendocrine neoplasms. Most pituitary adenomas and prolactinomas readily express chromogranin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MiTF IHC

Microphthalmia (MiTF) is a transcription factor implicated in pigmentation, bone development, and in mast cells. Various forms of MiTF exist ranging from 50 -70 kD in size. This antibody targets the 52 – 56 kD range and has been useful in identifying malignant melanoma and distinguishing mast cell lesions from lesions of myeloid derivation. A relatively rare class of tumors known as PEComas (tumors showing perivascular epithelioid cell differentiation) express MiTF in a high percentage of cases (~90%).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PMS-2 IHC

Microsatellite instability (MSI) is characterized by genome-wide alterations in short, repetitive DNA sequences. It is caused by defects in the nucleotide mismatch repair (MMR) system1. Biologically, defective MMR results in a general increase in the mutation rate and the development of a “mutator phenotype”1,2,3,4,5. In colorectal cancer (CRC), high-level MSI was first described in tumors from patients with hereditary non-polyposis colorectal cancer (HNPCC). In about 70% of cases, the HNPCC syndrome develops as a result of an inherited germline mutation of one allele, followed by a somatic mutation of the other allele in one of several mismatch repair genes: hMSH2, hMLH1, hPMS1, hPMS2, hMSH6, and hMLH32,6. 95% percent of the mutations occur in hMSH2 or hMLH12,6,7. Most colorectal carcinomas are thought to be of the chromosomal instable (CIN) or microsatellite stable (MSS) genotype. However, approximately 15% are thought to be of the MSI genotype, of which the HNPCC cases represent less than one-third2,7. The MSS and MSI tumors also seem to differ in clinicopathologic features. The MSI tumors are more often located in the proximal colon and may be synchronous. On histologic examination, they are more often mucinous or poorly differentiated. The patients with MSI-type colorectal carcinomas are generally thought to have a better prognosis than patients with MSS-type colorectal carcinomas. On the other hand, MSS tumors are more often located in the distal colon and represent typical adenocarcinomas6. Although the results published so far have been conflicting, some studies suggest that patients with MSS-type colorectal carcinomas seem to have a greater benefit from adjuvant chemotherapy (with 5-FU) than patients with MSI-type colorectal carcinomas. In contrast, there is some evidence that MSI-CRCs respond better to CPT-11 (irrinotecan) than MSS-CRCs

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PAX-8 IHC

This protein is a member of the paired box (PAX) family of transcriptionfactors. Members of this gene family typically encode proteins which contain a paired box domain, an octapeptide, and a paired-type homeodomain. This nuclear protein is involved in thyroid follicular cell development and expression of thyroid-specific genes. Mutations in this gene have been associated with thyroid dysgenesis, thyroid follicular carcinomas, and atypical thyroid adenomas. PAX-8 is expressed in the thyroid (and associated carcinomas), non- ciliated mucosal cells of the fallopian tubes, and simple ovarian inclusion cysts, but not normal ovarian surface epithelial cells. PAX-8 is expressed in a high percentage of ovarian serous, endometrioid, and clear cell carcinomas, but only rarely in primary ovarian mucinous adenocarcinomas. Studies have also found PAX-8 expression in renal tubules as well as renal cell carcinoma, nephroblastoma, and seminoma. A study by Tong et al. showed that 98% of clear cell RCCs, 90% of papillary RCCs, and 95% of oncocytomas were positive for anti-PAX-8 with frequencies of positivity that are similar to anti-PAX-2. Therefore, anti-PAX-8 may be used as an additional immunohistochemical marker for renal epithelial tumors. Normal lung and lung carcinomas do not express PAX-8. Similarly, the absence of expression of PAX-8 in breast and other non-GYN carcinomas other than those primary to the thyroid indicates that anti-PAX-8 is an important new marker of ovarian cancer and a useful marker for the differential diagnoses in lung and neck tumors, or tumors at distant sites where primary lung carcinoma, breast carcinoma or thyroid carcinoma are possibilities. Anti-PAX-8, combined with organ system-specific markers such as anti-uroplakin III, anti- mammaglobin, and anti-TTF-1, can collectively serve as a very useful panel to determine the primary site of invasive micropapillary ovarian carcinomas from invasive carcinomas arising from bladder, lung, and breast.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MSH-6 IHC

MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC). The anti-MSH6 antibody is useful in screening patients and families for this condition. Colon cancers that are microsatellite unstable have a better prognosis than their microsatellite stable counterparts.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MSH-2 IHC

MSH2 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as hereditary nonpolyposis colon cancer (HNPCC). The anti-MSH2 antibody is useful in screening patients and families for this condition. It has been shown that colon cancers that are microsatellite unstable have a better prognosis than their microsatellite stable counterparts.1-8 Anti-MSH2 is utilized in an IHC panel that includes anti-MLH1, anti-MSH6, and anti-PMS2.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

H.PYLORI IHC

The stated primary antibody (215A-7 series) may be used as the primary antibody for immunohistochemical staining of formalin-fixed, paraffin-embedded tissue sections. In general, immunohistochemical staining in conjunction with a streptavidin-biotin detection system allows the visualization of antigens via the sequential application of a specific antibody (primary antibody) to the antigen, a secondary antibody (link antibody) to the primary antibody, an enzyme complex and a chromogenic substrate with interposed washing steps. Alternatively, a biotin-free polymer detection system may be used. The enzymatic activation of the chromogen results in a visible reaction product at the antigen site. The specimen may then be counterstained and a coverslip applied. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

HPL IHC

Human placental lactogen (hPL), also previously known as ‘human chorionic somatomammotropin’, is a 22 kD protein with partial homology to growth hormone. hPL is first detectable in the maternal serum in the fifth week of gestation and reaches a plateau by the thirty-fourth week. hPL has been demonstrated by immunochemistry in the syncytiotrophoblastic cells of choriocarcinoma.    A rare variant of trophoblastic tumor has been reported in the testis with resemblance to uterine placental    Visualization Cytoplasmic site trophoblastic tumor.    It consists purely of intermediate trophoblasts which are diffusely positive for hPL and focally for β-hCG.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

HHV-8 IHC

Human herpes virus type 8 (HHV-8) is the likely etiologic agent of Kaposi’s sarcoma (KS). HHV-8 DNA sequences have been found in Kaposi’s sarcoma lesions, primary effusion lymphoma, and multicentric Castleman’s disease via polymerase chain reaction and in situ hybridization. Latent nuclear antigen (LNA-1, LNA, LANA-1), also known as ORF73, is a 222 or 234 kD protein that is consistently expressed in HHV-8 infected cells. Anti-HHV-8 labels the latent nuclear antigen protein via immunohistochemistry.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

DOG1 IHC

Anti-DOG1 has been shown to be highly specific and sensitive in the diagnosis of gastrointestinal stromal tumors (GIST). Approximately 4%-15% of GIST stain weakly or are negative for anti-c-kit (anti-CD117) by immunohistochemistry. In the vast majority of anti-CD117 (-) GIST cases, anti-DOG1 is expressed by IHC. Therefore, combined use of antibodies against CD117 and DOG1 will increase sensitivity and specificity of the detection.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

VZV IHC

Anti-Varicella Zoster Virus is a cocktail of seven mouse monoclonal antibodies from supernatant diluted tris buffered saline, pH 7.3-7.7, with protein base, and preserved with sodium azide. Analytical and performance characteristics are not established

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

WT1 IHC

WT1 is a gene involved in the induction of Wilms’ tumor, a pediatric renal malignancy. Wilms’ tumor 1 protein regulates transcription of other genes and can function both as a transcriptional activator and repressor. The antibody reacts with all isoforms of the full-length WT1 and also identifies WT1 lacking exon 2-encoded amino acids, frequently found in subsets of sporadic Wilms’ tumors. WT1 expression has been demonstrated in the epithelial and blastemal components of Wilms’ tumors and in the majority of malignant mesotheliomas as well as the majority of acute leukemias.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

VIMENTIN IHC

Vimentin is a 57 kDa intermediate filament protein which forms part of the cytoskeleton of vertebrate cells and is characteristically found in cells of mesenchymal origin. The coexpression of intermediate filaments, particularly vimentin and cytokeratin, has been demonstrated in a variety of normal cells/tissues and in neoplastic lesions, necessitating the use of antibodies against other types of intermediate filaments. The antibody is useful for the identification of cells of mesenchymal origin in normal and neoplastic tissues.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

VILLIN IHC

Villin is a 95 kDa calcium-regulated, actin-binding protein that plays a role iin regulating actin filament assembly. It is a major constituent in the microvilli, which compose the brush border of epithelial cells forming absorptive surfaces of the intestinal and renal proximal tubular epithelia. In normal human tissue, villin is expressed by a limited number of simple epithelia of the gastrointestinal and urogenital tract. Among neoplasms, villin is predominantly expressed in tumors of colorectal origin. Antibodies to villin are useful in identifying malignant cells from primary and metastatic colorectal carcinomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

TTF-1 IHC

Identifies the 40 kDa TTF-1 band in nuclear extracts or whole cell lysates of TTF-1-positive cell lines of rat, mouse and man. TTF-1 is selectively expressed in lung and thyroid, and the antibody may aid in the classification of tumors of the lung and thyroid.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

TRYPTASE IHC

Staining for mast cell tryptase is useful for the identification and enumeration of mast cells in tissue sections. The stain also detects atypical or immature mast cells associated with various subtypes of mastocytosis.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

SYNAPTOPHYSIN IHC

Synaptophysin is a 38 kDa membrane glycoprotein expressed in neuroendocrine cells and neurons involved in transmission via synaptic vehicles. Despite its abundance, the function of synaptophysin remains largely unknown, however an effect on efficient endocytosis of synaptic vesicles has recently been reported.Synaptophysin is a useful marker for identification of neuroendocrine neoplasm, such as neuroendocrine lung tumors (e.g. carcinoid, atypic carcinoid, SCLC, LCNEC and non-small cell lung cancer), neuroendocrine tumors of the gastroenteropancreatic tract, e.g. neuroendocrine tumors (NETs), neuroendocrine carcinoma (NECs) and other epithelial neuroendocrine neoplasms such as pituitary adenomas, medullary thyroid carcinoma and parathyroid adenomas. The new clone DAK-SYNAP is raised against a recombinant immunogen corresponding to the C-terminal cytoplasmic domain of human synaptophysin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

SMA IHC

This antibody labels smooth muscle cells, myofibroblasts and myoepithelial cells. It is useful for the identification of leiomyomas, leiomyosarcomas (1), and pleomorphic adenomas (2).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

S100 IHC

Z0311 labels glial cells in the brain and ependymal cells. Moreover, Schwann’s cells of the peripheral nervous system are positive. Among tumors of the human central and peripheral nervous system, a positive reaction is seen in schwannomas, ependydomas as well as in different grades of astrogliomas, also including glioblastomas. A large proportion of cells in human tumors originating from different salivary glands are stainable with anti-S100. S100 is present in almost all human benign and malignant melanocytic tumors of the skin and in metastases of human malignant melanomas. The antibody is a useful tool for the classification of S100-positive neoplasms. It is mandatory that antibodies to S100 are used together with a panel of other antibodies.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PSA IHC

Prostate-specific antigen (PSA) is a 33 kDa protein belonging to the kallikrein family of proteases. It is primarily produced by the prostatic epithelium and the epithelial lining of the periurethal glands. PSA is strongly expressed in both normal and neoplastic prostatic tissue. This antibody is useful for the identification of human prostate-specific antigen.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PROTEINASE K IHC

Proteinase K is intended for proteolytic digestion of formalin-fixed, paraffin-embedded tissues prior to immunohistochemical or in situ hybridization procedures.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PR IHC

Labels the nuclei of cells known to contain a high level of progesterone receptor. This is, e.g., normal, hyperplastic and neoplastic cells of the mammary gland as well as epithelial and myometrial cells of the uterus.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PMS2 IHC

PMS2 is a DNA mismatch repair protein. Loss of PMS2 expression in carcinoma or adenoma cells, as a result of mutation in MLH1 or PMS2 genes, is associated with hereditary non-polyposis cancer syndrome (Lynch syndrome, Muir-Torre syndrome). MLH1 and PMS2 expression may also be altered as a result of MLH1 promoter hypermethylation, a sporadic abnormality associated with BRAF V600E mutation. Evaluation of PMS2 expression by immunohistochemistry in colorectal and endometrial adenocarcinomas, as well as in sebaceous neoplasms is of value in identifying patients with Lynch syndrome. This information is important in management of their neoplasms, as well as for lifelong monitoring and genetic counseling. This test may be performed on tumor samples individually, or as a part of the MMR panel .

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

PAX-5 IHC

PAX5 (B-cell-specific activator protein, BSAP), is expressed by normal B-lymphoid cells ranging from early B-cell progenitors to post-germinal center B-cells, and is lost at the plasma cell stage. PAX5 is expressed by all types of B-cell non-Hodgkin lymphoma, classical and nodular lymphocyte predominant Hodgkin lymphoma, precursor B-lymphoblastic leukemias, AML with t(8;21), as well as rare cases of peripheral T-cell lymphoma and Merkel cell tumors.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

p504s IHC

AMACR, also known as P504S, is an enzyme that is involved in bile acid biosynthesis and β-oxidation of branched-chain fatty acids. It is expressed in cells of premalignant high-grade prostatic intraepithelial neoplasia (HGPIN) and prostate adenocarcinoma (1). In glandular epithelial cells of normal and benign hyperplastic prostates AMACR is present at low or undetectable levels.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

p53 IHC

Reacts with the wild type and mutant type of the p53 protein. The antibody is useful for demonstrating accumulation of p53 protein, which occurs in a high frequency in tumors of all cell lineages.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MUM1 IHC

MUM1 protein is expressed in a subset of germinal center B cells, plasma cells and activated T cells. It is also expressed in a wide spectrum of hematolymphoid neoplasms derived from these cells and in melanomas are labeled. In particular, immunohistochemical staining for MUM1 is useful in the classification of aggressive B-cell lymphoma, as MUM1 expression is characteristic of non-germinal center diffuse large B-cell lymphoma and is not seen in Burkitt lymphoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MUSCLE ACTIN IHC

The antibody recognizes rhabdomyosarcomas, leiomyomas and leiomyosarcomas, and also reacts with ‘myofibroblasts’ in the stroma of certain tumors including many carcinomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MSH6 IHC

MSH6 is a DNA mismatch repair protein. Loss of MSH6 expression in carcinoma or adenoma cells, typically as a result of mutation in MSH6 or MSH2 genes, is associated with hereditary non-polyposis cancer syndrome (Lynch syndrome, Muir-Torre syndrome). Evaluation of MSH6 expression by immunohistochemistry in colorectal and endometrial adenocarcinomas, as well as in sebaceous neoplasms is of value in identifying patients with Lynch syndrome. This information is important in management of their neoplasms, as well as for lifelong monitoring and genetic counseling. This test may be performed on tumor samples individually, or as a part of the MMR panel.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MSH2 IHC

MSH2 is a DNA mismatch repair protein. Loss of MSH2 expression in carcinoma or adenoma cells, typically as a result of mutation in MSH2 or MSH6 genes, is associated with hereditary non-polyposis cancer syndrome (Lynch syndrome, Muir-Torre syndrome). Evaluation of MSH2 expression by immunohistochemistry in colorectal and endometrial adenocarcinomas, as well as in sebaceous neoplasms is of value in identifying patients with Lynch syndrome. This information is important in management of their neoplasms, as well as for lifelong monitoring and genetic counseling. This test may be performed on tumor samples individually, or as a part of the MMR panel.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MLH1 IHC

MLH1 is a DNA mismatch repair protein. Loss of MLH1 expression in carcinoma or adenoma cells, as a result of mutation in MLH1 or PMS2 genes, is associated with hereditary non-polyposis cancer syndrome (Lynch syndrome, Muir-Torre syndrome). MLH1 and PMS2 expression may also be altered as a result of MLH1 promoter hypermethylation, a sporadic abnormality associated with BRAF V600E mutation. Evaluation of MLH1 expression by immunohistochemistry in colorectal and endometrial adenocarcinomas, as well as in sebaceous neoplasms is of value in identifying patients with Lynch syndrome. This information is important in management of their neoplasms, as well as for lifelong monitoring and genetic counseling. This test may be performed on tumor samples individually, or as a part of the MMR panel .

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

MELAN-A IHC

The antibody is useful for the identification of melanomas, and, if melanoma is ruled out, for adrenocortical carcinomas. Melan-A is also a useful marker for identification of angiomyolipomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Mammaglobin IHC

Mammaglobin expression is mostly, although not exclusively, confined to breast tissue, and anti-mammoglobin is, together with a panel of other antibodies, useful for the identification and classification of carcinomas of breast origin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

LAMBDA IHC

Immunoglobulin lambda light chain can be detected immunohistochemically in benign plasma cells present in polyclonal plasma cell expansions associated with chronic inflammatory infiltrates, where they are typically admixed with kappa+ plasma cells. Iglambda is also detected in clonal (Ig lambda restricted) plasma cells associated with plasma cell neoplasms (MGUS, myeloma), B-cell non-Hodgkin lymphoma with plasmacytic differentiation, plasmablastic B-cell lymphoma and aggressive B-cell lymphomas with immunoblastic differentiation. Iglambda is typically evaluated together withh Igkappa expression to determine light-chain restriction (clonality).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

KI-67 IHC

The Ki-67 antigen is a nuclear protein expressed during all active phases of the cell cycle (G1, S, G2 and M-phase), but absent in resting cells (G0-phase). It is used to evaluate the fraction of proliferating cells (proliferation index) present in a cellular infiltrate. This evaluation is important for diagnostic purposes (e.g. to identify aggressive B-cell lymphomas and differentiate from low-grade B-cell lymphomas) and prognostic purposes (increased proliferation index may be associated with poor prognosis in some neoplasms). The Ki-67 antigen is poorly preserved in acid decalcified tissues and therefore it may be of suboptimal quality in bone marrow biopsy samples, bone biopsy and bone resection samples.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

KAPPA IHC

Immunoglobulin kappa light chain can be detected immunohistochemically in benign plasma cells present in polyclonal plasma cell expansions associated with chronic inflammatory infiltrates, where they are typically admixed with lambda+ plasma cells. Igkappa is also detected in clonal (Ig kappa restricted) plasma cells associated with plasma cell neoplasms (MGUS, myeloma), B-cell non-Hodgkin lymphoma with plasmacytic differentiation, plasmablastic B-cell lymphoma and aggressive B-cell lymphomas with immunoblastic differentiation. Igkappa is typically evaluated together withh Iglambda expression to determine light-chain restriction (clonality).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

IgM IHC

IgM is normally expressed on membranes of B-cells in the germinal center and mantle zones of reactive follicles, as well as in subsets of polyclonal plasma cells. It is also expressed in the plasma cells associated with some B-lymphoid neoplasms (lymphoplasmacytic lymphoma, CLL/SLL, marginal zone lymphoma) and in very rare cases of plasma cell myeloma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

IgD IHC

IgD is normally expressed at high levels by normal naïve B-cells in the mantle zones of reactive follicles. Staining for IgD may be used to evaluate follicular architecture. IgD is expressed in some lymphoid neoplasms (mantle cell lymphoma, CLL/SLL) and in rare cases of plasma cell myeloma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

H. pylori IHC

The antibody labels H. pylori on the surface and in the cytoplasm of epithelial cells in stomach biopsies.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

HMB45 IHC

Labels an intracytoplasmic antigen in the majority of melanomas and other tumors demonstrating melanoma/melanocytic differentiation. The antibody also reacts with junctional and blue nevus cells.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

HERCEPT TEST (Her-2/neu) IHC

HercepTest™ is an FDA-approved semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in gastroesophageal adenocarcinoma cells from formalin-fixed, paraffin-embedded tissue samples. In our laboratory this immunohistochemical assessment is combined with FISH evaluation of the status of Her-2/neu gene, and both results are reported to aid in clinical decision. Positive or negative results provide a basis for Herceptin® (trastuzumab) treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient’s clinical history.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

GCDFP-15 IHC

GCDFP-15 is a marker of apocrine differentiation, and is expressed in breast cystic fluid as well as in apocrine, lacrimal, ceruminous, Moll’s and eccrine glands. GCDFP-15 expression is found in neoplastic cells from primary and metastatic tumors of the breast. With the exception of carcinomas of the salivary gland, sweat gland and prostate, the majority of other neoplasms evaluated are GCDFP-15-negative. Antibodies to GCDFP-15 are useful for the identification of breast carcinoma and metastatic tumors of breast origin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Gastrin IHC

This antibody labels cells producing gastrin or structural gastrin analogues.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

ER IHC

This monoclonal rabbit antibody reacts with human estrogen receptor α (ER α). Estrogens have been found to be preferentially concentrated in the estrogen target organs of animals and in human breast cancers, and it is well documented that the mitogenic effects of estrogen are mediated by ER. Historical studies have shown that ER status is correlated with untreated outcome (i.e. prognostic for well-differentiated invasive breast cancer) and with response to anti-hormonal therapy, e.g. tamoxifen (1). The antibody may be used in the semi-quantitative detection of human estrogen receptor in tissue sections of human breast cancer by immunohistochemistry

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

EMA IHC

The antibody is very useful together with the monoclonal antibodies to leucocyte common antigen (Code M0701) and cytokeratin (Code M0821), which label cells of lymphoid and epithelial origin, respectively. In the classification of hematolymphoid neoplasms, the antibody labels Reed-Sternberg cells in nodular lymphocyte predominant Hodgkin’s lymphoma and neoplastic cells in a subset of anaplastic large cell lymphomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

DESMIN IHC

Anti-Desmin, clone D33, is of value in the differential diagnosis of tumors of uncertain origin. It can be used in conjunction with the Dako monoclonal antibodies to the other intermediate filament proteins, such as cytokeratin (Code M0821), glial fibrillary acidic protein (Code M0761), neurofilament protein (Code M0762), vimentin (Code M7020) and the monoclonal antibody to leucocyte common antigen (Code M0701).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

D2-40 IHC

Identifies the ~38 kDa O-linked transmembrane sialoglycoprotein podoplanin, which is expressed in the endothelium of lymphatic capillaries, but not in the blood vasculature (1). Besides the expression in lymphatic endothelium, podoplanin is also found in a variety of other tissues, including mesothelial cells, reticular cells, follicular dendritic cells, ovarian and testicular germ cells (2). Anti-Podoplanin, Clone D2-40 labels lymphatic endothelium whereas it is unreactive with vascular endothelium. In neoplastic tissue, immunostaining of lymphatic endothelium by the antibody has been shown to be useful in identifying lymphatic invasion of primary tumors.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CYCLIN D IHC

Cyclin D1 is a cell-cycle-associated protein expressed in the nuclei of proliferating epithelial cells and activated endothelial cells. It is also expressed in a variety of neoplasms, mostly importantly in some B-cell lymphomas (e.g. mantle cell lymphoma, hairy cell leukemia) and plasma cell myeloma associated with t(11;14).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CMV IHC

Reacts with CMV immediate early antigen and early antigen. The antibody shows no cross-reaction with other herpesviruses or with adenovirus.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CK AE1/AE3 IHC

The antibody labels keratinized and corneal epidermis, stratified squamous epithelia of internal organs, stratified epithelia, hyperproliferative keratinocytes, and simple epithelia. The antibody is useful for the identification of tumors as carcinoma or epithelial origin and for differential identification of undifferentiated carcinomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CK34BE12 IHC

The antibody labels squamous, ductal and complex epithelia, and is useful in the differentiation of benign prostate glands from prostatic adenocarcinoma and the classification of neoplastic tissue as carcinoma or epithelial origin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CK20 IHC

The antibody labels the majority of adenocarcinomas of the colon, mucinous ovarian tumors, transitional-cell and Merkel-cell carcinomas, and frequently adenocarcinomas of the stomach, bile system and pancreas. Most squamous cell carcinomas and most adenocarcinomas from other sites (breast, endometrium, lung, prostate), non-mucinous tumors of the ovary, and small-cell lung carcinomas are essentially or completely negative.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CK7 IHC

The antibody labels several types of normal and neoplastic epithelia, including many ductal and glandular epithelia. Clone OV-TL 12/30 has been found useful for the identification of adenocarcinomas of the lung, breast and endometrium, thyroid gland and ovary, as well as chromophobe renal cell carcinomas. Antibodies to cytokeratin 7 may also be useful in the differential diagnosis of prostate carcinomas where CK7 is rarely expressed.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CK5/6 IHC

It labels mesothelioma, and epithelial basal cells in prostate and tonsil. No reactivity with other mesodermally derived tissues, such as muscle and connective tissues, has been observed.Cytokeratin 5/6 is expressed at low levels in adenocarcinomas, whereas it is present at high levels in epithelioid mesotheliomas, and the antibody is, therefore, very useful in the differentiation between these types of cancer.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CEA IHC

CEA is a clinically important marker for adenocarcinomas, notably in the gastrointestinal tract, including colonic and pancreatic carcinomas. The characteristic CEA expression of secretory meningiomas is labeled by the antibody (2). Antibodies to CEA may also be useful for the identification of medullary carcinoma of the thyroid

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CDX-2 IHC

The CDX2 protein is widely expressed in intestinal epithelium from the duodenum to the rectum. Scattered expression has been reported in pancreatic ductules, while no expression has been observed in other normal tissues tested. The majority of colorectal adenocarcinomas, a large part of gastric adenocarcinomas, carcinoids of the GI tract as well as adenocarcinomas of the ovary, urinary bladder and pancreas show CDX2 expression. Antibodies to CDX2 may be useful for identification of both primary and metastatic tumors of the gastrointestinal tract, including carcinoids.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD138 IHC

Staining for CD138 highlights precursor B-cells (hematogones) and mature plasma cells. It is also typically expressed in plasma cell neoplasms (MGUS, myeloma) and in plasmablastic lymphomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD117 IHC

CD117/c-kit is expressed on the membrane of hematopoietic stem cells, melanocytes, mast cells, Cajal cells, germ cells, basal cells of skin, and mammary ductal epithelia. CD117 is also expressed by abnormal mast cells in mastocytoses, blasts of acute myeloid leukemias, gastrointestinal stromal tumors (GISTs).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD68 IHC

CD68 is expressed in normal monocytes, macrophages, and dendritic cells with a granular cytoplasmic pattern. CD68 is also expressed by the neoplastic cells in Langerhans cell histiocytosis, monocytic/monoblastic leukemia, plasmacytoid dendritic cell neoplasms, anaplastic large cell lymphoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD56 IHC

CD56 is expressed in the membrane of normal NK cells and subsets of CD8+ cytotoxic T-cells, as well as on normal cells of neural origin. Partial, weak CD56 expression may also be detected in subsets of normal plasma cells and on immature myeloid and monocytic cells in regenerative (reactive) processes. CD56 expression is present on a large variety of hematopoietic neoplasms, including T-cell lymphomas, B- and T-lymphoblastic leukemia/lymphoma, NK and T-large granular lymphocyte proliferations, acute myeloid leukemias, plasma cell neoplasms (MGUS, myeloma) and plasmacytoid dendritic cells neoplasms. CD56 is also expressed on neural and neuroendocrine neoplasms (e.g. neuroblastoma, small cell carcinoma).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD45 IHC

CD45 is expressed on the membrane of most normal and neoplastic cells of hematopoietic origin at all stages of maturation. CD45 expression is regarded as a highly useful marker of hematopoietic lineage in staining panels for poorly differentiated neoplasms. However, some hematopoietic neoplasms may be negative for CD45. These include myelomas, some plasmablastic lymphomas, some acute myeloid and lymphoblastic leukemia cases, and some cases of T-anaplastic large cell lymphoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD43 IHC

CD43 is normal expressed on the membrane of normal T-lymphocytes, some activated B-lymphocytes, monocytes, granulocytes, plasma cells, platelets and B-lymphoid precursors (hematogones). Staining for CD43 is useful in characterizing abnormal B-immunophenotypes in B-cell lymphomas (e.g. marginal zone lymphoma, mantle cell lymphoma, CLL/SLL), and in marking poorly differentiated blastic infiltrates of myeloid or monocytic sarcoma, where CD43 is occasionally the only hematopoietic marker expressed by immunohistochemistry. CD43 is useful in supporting a hematopoietic origin for poorly differentiated neoplasms, as it is highly specific for hematopoietic lineage.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD34 IHC

CD34 is expressed on the membrane of early progenitor cells (stem cells, committed myeloblasts and lymphoblasts) and of endothelial cells. It is also expressed by the blasts in most cases of acute leukemia (myeloid, lymphoid or mixed phenotype), by the neoplastic cells in benign and malignant vascular tumors (e.g. Kaposi sarcoma, angiosarcoma) and of some soft tissue tumors (e.g. dermatofibrosarcoma protuberans, solitary fibrous tumor, gastrointestinal stromal tumors, some peripheral nerve sheath tumors).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD31 IHC

The antibody strongly labels endothelial cells and is valuable for the demonstration of capillaries and neoplasms arising from endothelial cells. Additionally, this marker may be expressed by blastic cells in some cases of acute megakaryoblastic leukemia.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD30 IHC

CD30 is expressed in the membrane and Golgi zone of normal activated B- and T-lymphocytes (immunoblasts). CD30 expression is found on neoplastic cells of some peripheral T-cell lymphomas, some of which are defined by the presence of this marker (e.g. anaplastic large cell lymphoma, CD30+ primary cutaneous T-cell lymphomas), mediastinal large B-cell lymphomas, Hodgkin and Reed-Sternberg cells of classical Hodgkin lymphoma and embryonal carcinoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD23 IHC

CD23 is expressed in the membrane of subsets of peripheral blood mature B-lymphocytes and some B-cell found in the mantle zone of the B-lymphoid follicles and normal follicular dendritic cells. It is expressed by some B-cell neoplasms (e.g. chronic lymphocytic leukemia, hairy cell leukemia, marginal zone lymphoma). Staining for CD23 may be used to highlight normal or disrupted follicular dendritic cell networks in neoplasms such as follicular lymphoma (especially when excluding the presence of diffuse areas), marginal zone lymphomas with follicular colonization, lymphocyte-predominant Hodgkin lymphoma. Additionally, this marker may be positive in follicular dendritic cell tumors.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD20 IHC

CD20 is expressed on the membrane of mature B-cells and precursor B-cells at some stages of maturation. It is also expressed at variable intensity in most mature B-cell non-Hodgkin lymphomas, many cases of precursor B lymphoblastic lymphoma/leukemia (typically weak and variable in the latter), lymphocyte-predominant Hodgkin lymphoma, a subset of classical Hodgkin lymphoma, and some myelomas [characteristically myeloma with t(11;14)]. While regarded as a highly specific B-lineage associated marker, it has been rarely found in some mature T-cell lymphomas and carcinomas. Notably, any of these B-cell neoplasms may become CD20-negative following therapy with agents targeting CD20 (e.g. Rituximab), and staining for alternative B-cell markers (e.g. PAX5) is recommended for B-cell detection in such cases.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD15 IHC

CD15 (LeuM1) is expressed on the membrane of normal myeloid cells (but not CD34+ blasts), monocytic and dendritic cells and of some epithelial cells (e.g. bronchial cells). It is also expressed by the neoplastic cells in acute myeloid leukemia and other myeloid neoplasms, Hodgkin and Reed-Sternberg cells in classical Hodgkin lymphoma and some adenocarcinomas (where it is useful in the differential diagnosis with mesothelioma, which is typically negative for this antigen).

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD10 IHC

CD10 is expressed on the membrane of normal precursor B cells, mature germinal center B-cells and mature neutrophil granulocytes, germinal center-associated T-cells, as well as on epithelial cells of small intestine, bile canaliculi and kidney. It is also expressed in B-cell lymphomas of germinal center subtype (follicular lymphoma, Burkitt lymphoma, diffuse large B-cell lymphoma – germinal center subtype), precursor B-lymphoblastic lymphoma/leukemia, angioimmunoblastic T-cell lymphomas and renal cell carcinoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD8 IHC

CD8 is variably expressed by on the membrane of subsets of normal T cells (cytotoxic alpha/beta T-cells, gamma/delta T-cells), NK cells and on precursor T-cells starting at the medullary thymocyte stage (where it is co-expressed with CD4) and splenic endothelial cells (littoral cells). It is also expressed at variable levels by subsets of precursor and mature T-cell neoplasms, and by some splenic vascular neoplasms.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD7 IHC

CD7 is a pan-T-cell marker expressed on the membrane of all T-cell subsets (including early precursor T-cells) and NK cells. It is also expressed at variable levels by precursor and mature T-cell neoplasms, NK cell proliferations, and blasts in some acute myeloid leukemias and mixed phenotype acute leukemias.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD5 IHC

CD5 is a pan-T-cell marker expressed on the membrane of all T-cell subsets (including early precursor T-cells), partially and weakly on subsets of normal B-lymphocytes, and on thymic epithelial cells. It is also expressed at variable levels by precursor and mature T-cell neoplasms, some B-cell lymphomas (including CLL/SLL, mantle cell lymphoma, CD5+ marginal zone lymphoma, CD5+ diffuse large B-cell lymphoma) and on thymic carcinomas.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD4 IHC

CD4 is expressed strongly on the membrane of a subset of normal T-cells (helper T-cells) and of T-cell precursors starting at the medullary thymocyte stage (where it is co-expressed with CD8), as well as of normal mature and immature monocytic and dendritic cells (at lower density than on the T-cells). CD4 expression may be detected by immunohistochemistry in subsets of T-lymphoblastic lymphoma, peripheral T-cell lymphoma, tissue infiltrates of acute monocytic/monoblastic leukemia (monocytic sarcoma), dendritic cell proliferations (e.g. Langerhans cell histiocytosis) and plasmacytoid dendritic cell neoplasms.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD3 IHC

CD3 is a highly specific pan-T cell marker expressed on the membrane of all subsets of normal T cells and in early precursor T-cells (where it is predominantly cytoplasmic). It is most useful for the characterization of lymphoid neoplasms, where cytoplasmic or membrane expression defines T-cell lineage in T-lymphoblastic leukemia/lymphoma, peripheral T-cell lymphomas and mixed phenotype (T/myeloid) acute leukemias.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD2 IHC

CD2 is a pan-T-cell marker expressed on the membrane of all T-cell subsets (including early precursor T-cells) and NK cells. It is also expressed at variable levels by precursor and mature T-cell neoplasms, NK cell proliferations, neoplastic mast cells of systemic mastocytosis and monocytes in some acute myeloid leukemias.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

CD1A IHC

CD1a is expressed on the membrane of normal and neoplastic Langerhans cells, interdigitating dendritic cells and medullary thymocytes. It is also expressed by a large subset of T-lymphoblastic lymphomas/leukemias that represent the neoplastic counterpart of medullary thymocytes.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Calretinin IHC

It is abundantly expressed in central and peripheral neural tissues, particularly in the retina and in the neurons of the sensory pathways, and calretinin may play an important role in the survival of nerve cells during disturbances in calcium homeostasis. Calretinin is also expressed by both normal and neoplastic mesothelial cells, and it has been suggested as a useful marker for the identification of malignant mesotheliomas of the epithelial type and for the differentiation of these malignancies of lung adenocarcinoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

BerEp4 IHC

Epithelial antigen is a transmembrane glycoprotein functioning as a cellular adhesion molecule. This epithelium-specific antigen is broadly distributed in epithelial cells, and displays a highly conserved expression in carcinomas. The antibody is useful in the differential diagnosis of adenocarcinoma versus malignant mesothelioma. Anti-Epithelial Antigen may also aid in detection of micrometastases in lymph nodes of patients with esophageal carcinoma as well as in differentiation between basal and squamous cell carcinomas of the skin.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

BCL-6 IHC

BCL6 is expressed predominantly in the nuclei of normal germinal centre B cells and in a subset of T-lymphocytes that home to the skin. BCL6 is also expressed in germinal center-related B-cell lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, Burkitt’s lymphomas, and nodular, lymphocyte-predominance Hodgkin lymphoma. It is most useful in the work-up of B-cell lymphoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

TCL2A FISH

•Disease(s): T-Cell Lymphoma
•Probes:
◦TCL1 (14q32.13)
◦TCL1 (14q32.13)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

ALK FISH

•Disease(s): T-anaplastic large cell lymphoma, subsets of adenocarcinoma of lung and breast, inflammatory myofibroblastic tumors.
•Probes:
◦ALK (2p23)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(14;16) FISH

•Disease(s): Plasma cell myeloma (prognostic)
•Probes:
◦MAF (16.23)
◦IGH (14q32.3)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(4;14) FISH

•Disease(s): Plasma cell neoplasms (prognostic)
•Probes:
◦FGFR3 (4p16.3)
◦IGH (14q32.3)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

13q abnormalities FISH

•Disease(s): Myelodysplastic syndromes, plasma cell myeloma, B-lymphoid neoplasms (prognostic in myeloma and chronic lymphocytic leukemia)
•Probes:
◦D13S319 (13q14.2)
◦13qter (13q34)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

CEP 3/9 copy number FISH

•Disease(s): Plasma cell neoplasms (prognostic)
•Probes:
◦CEP3
◦CEP9

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

1p/1q copy number FISH

•Disease(s): Plasma cell neoplasms (prognostic)
•Probes:
◦1q21 (2CKS1B)
◦1p32.3 (CDKN2C)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

FOX01 FISH

•Disease(s): Myelodysplastic Syndrome
•Probes:
◦FOX01 (13q14)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

EVI1 FISH

•Disease(s): Myelodysplastic syndromes, acute myeloid leukemia
•Probes:
◦EVI1 (3q26.2)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

t(14;18) FISH

•Disease(s): Follicular lymphoma, chronic lymphocytic leukemia (rare cases), classification and prognosis of aggressive B-cell lymphomas
•Probes:
◦BCL2 (18q21)
◦IGH (14q32.3)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

6q FISH

•Disease(s): B-cell non-Hodgkin lymphoma and B-lymphoblastic leukemia; prognostic in lymphoplasmacytic lymphoma
•Probes:
◦MYB (6q23)
◦D6Z1 (6p11.1-q11.1)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

BCL6 FISH

•Disease(s): B-cell non-Hodgkin lymphoma, classification and prognosis of aggressive B-cell lymphomas
•Probes:
◦BCL6 (3q27.3)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

FGFR1 FISH

•Disease(s): Myeloid neoplasms associated with eosinophilia
•Probes:
◦FGFR1 (8p12)
◦D8Z2 (8p11.1-q11.1)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

PDGFRβ FISH

•Disease(s): Eosinophilia, Myeloproliferative Disease
•Probes:
◦PDGFRB (5q32)
◦PDGFRB (5q32)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

PDGFRα FISH

•Disease(s): Myeloid neoplasms associated with eosinophilia
•Probes:
◦FIP1L1 (4q12)
◦CHIC2 (4q12)
◦PDGFRA (4q12)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x2

20q FISH

•Disease(s): Myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms, myeloproliferative neoplasms, plasma cell myeloma
•Probes:
◦PTPRT (20q12)
◦MYBL2 (20q13.12)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(9;22)/Philadelphia Chromosome FISH

•Disease(s): Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelomonocytic Leukemia, Eosinophilia, Myeloproliferative Disease •Probes:
◦ABL1 (9q34)
◦BCR (22q11.2)
◦ASSI (9q34)
◦Probes may be ordered separately “

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x2

IgH (BAP) FISH

•Disease(s): B-lymphoid neoplasms, plasma cell neoplasms
•Probes:
◦IGHC (14q32.3)
◦IGHV (14q32.3)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

RB1 FISH

•Disease(s): Chronic lymphocytic leukemia – deletion of 13q involving RB1 locus has prognostic significance
•Probes:
◦RB1 (13q14.2)
◦13qter (13q34)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

Chromosome 12 FISH

•Disease(s): Trisomy in chronic lymphocytic leukemia
•Probes:
◦MDM2 (12q15)
◦D12Z1 (12p11.1-q11.1)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

ATM (copy number abnormalities) FISH

•Disease(s): Lymphoid, myeloid and plasma cell neoplasms, prognostic
•Probes:
◦ATM (11q22.3)

◦Probes for p53 and ATM may be ordered together or separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

p53 (copy number abnormalities) FISH

•Disease(s): Lymphoid, myeloid and plasma cell neoplasms, prognostic.
•Probes:
◦p53 (17p13) (CLL prognostic panel) CEP17/17p13 (myeloma prognostic panel)

◦Probes for p53 and ATM may be ordered together or separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(11;14) FISH

•Disease(s): Mantle cell lymphoma, plasma cell myeloma
•Probes:
◦CCND1 (11q13)
◦IgH (14q32)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(15;17) PML/RARA FISH

•Disease(s): Acute promyelocytic leukemia
•Probes:
◦PML (15q24.1)
◦RARA 17q21)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

CBFB rearrangement/inv(16) FISH

•Disease(s): Acute myeloid leukemia
•Probes:
◦CBFB (16q22)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

t(8;21) FISH

•Disease(s): Acute myeloid leukemia
•Probes:
◦RUNX1T1 (8q21.3)
◦RUNX1 (21q22)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

CEP8 FISH

•Disease(s): Acute myeloid leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms, myeloproliferative neoplasms, including blast phase of CML
•Probes:
◦MYC (8q24)
◦CEP8 (8p11.1-q11.1 )

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

7q FISH

•Disease(s): Myelodysplastic syndromes, chronic myelomonocytic leukemia, acute myeloid leukemia, hepatosplenic T-cell lymphoma
•Probes:
◦RELN, ORC5L (7q22)
◦TES (7q31)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

5q/chr 5 abnormalities FISH

•Disease(s): Myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms, plasma cell myeloma
•Probes:
◦EGR1 (5q31.2)
◦TASR1 (5p32)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(8;14) FISH

•Disease(s): Acute Lymphocytic Leukemia, Burkitt Lymphoma
•Probes:
◦CMYC (8q24)
◦IgH (14q32)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

p16 FISH

•Disease(s): B-lymphoblastic leukemia
•Probes:
◦p16 (9p21 )
◦D9z3 (3q12)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x1

t(9;22)/Philadelphia Chromosome FISH

•Disease(s): Chronic myelogenous leukemia, B-lymphoblastic leukemia
•Probes:
◦ABL1 (9q34)
◦BCR (22q11.2)
◦ASSI (9q34)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1, 88369x2

T-Cell Lymphoma FISH Panel FISH

•Disease(s): Peripheral T-cell lymphoma
•Probes:
◦ALK 2p23 (ALK)
◦RELN ORC5L 7q22/TES ;7q31 (7q)
◦MYC 8q16.3/ CEP8 8p11.1/IGH 14q32 t(8;14)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x4)

Multiple Myeloma Prognostic Panel FISH

•Disease(s): Abnormalities with prognostic significance in plasma cell myeloma
•Probes:
◦IGHC 14q32.3 (IGH)
◦1q21/1p32.3 (1p1q)
◦CEP3 /CEP9 (CEP3/9)
◦EGR1 5q31.2/TASR1 5p15.31 (5q)
◦CCND1 11q13/IGH 14q32.3 [t(11;14)]
◦D13S319 13q14.2/13qter 13q34 (13q)
◦CEP17/p53 (17p13)
◦FGFR3 4p16.3/IGH 14q 32.3 t(4;14) REFLEX
◦MAF 16q23/IGH 14q32.3 t(14;16) REFLEX

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x7), with a reflex to 88377(x9)

Myeloproliferative Disease (MPD) FISH Panel FISH

•Disease(s): Myeloproliferative neoplasms
•Probes:
◦PDGFRa, CHIC2, FIP1L1 (4q12)
◦PDGFRb (5q33)
◦FGFR1 (8p11)
◦BCR/ABL1 t(9;22) including ASS1 (9q34)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x4)

Myelodysplastic Syndrome (MDS) FISH Panel FISH

•Disease(s): Myelodysplastic syndromes and other myeloid neoplasms
•Probes:
◦EVI1 3q26.2 (EVI1)
◦EGR1 5q31.2/TASR1 5p15.31 (5q)
◦RELN, ORC5L 7q22/TES 7q31 (7q)
◦MYC 8q24/CEP8 8p11.1-q11.1 (CEP8)
◦D13S319/13qter (13q)
◦PTPRT 20q12/MYBL2 20q13.12 (20q)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x9)

B-Cell Lymphoma FISH Panel FISH

•Disease(s): Multiple subtypes of B-cell non-Hodgkin lymphoma
•Probes:
◦BCL6 (3q27)
◦MYB 6q23/D6Z1 6p11.1-q11.1 (6q)
◦MYC 8q24/CEP8 8p11.1-q11.1/IGH 14q32 t(8;14)
◦CCND1 11q13/IGH 14q32.3 t(11;14)
◦BCL2 18q21/IGH 14q32.3 t(14;18)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x5)

Eosinophilia FISH Panel FISH

•Disease(s):  Myeloid and lymphoid neoplasms associated with eosinophilia
•Probes:
◦FIP1L 4q12, CHIC2 4q12, PDGFRA 4q12 (PDGFRα)
◦PDGFRβ 5q32 (5q33) (PDGFRβ)
◦FGFR1 8p12/D8z2 8p11.-q11.1 (FGFR1)
◦ABL1 9q34/BCR 22q11.2/ASSI 9q34 t(9;22)
◦CBFB 16q22 (CBFB)

◦Probes may be ordered separately.

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x5)

Chronic Myelomonocyitc Leukemia (CMML) FISH Panel FISH

•Disease(s):  Abnormalities associated with chronic myelomonocytic leukemia and other myeloproliferative or myelodysplastic/myeloproliferative neoplasms; the panel includes BCR/ABL, which has to be excluded for a diagnosis of CMML (WHO criteria)
•Probes:
◦EGR1 5q31.2/TASR1 5p15.31 (5q)
◦RELN, ORC5L 7q22/TES 7q31 (7q)
CEP8/CMYC (+8)
◦ABL1 9q34/BCR 22q11.2/ASSI 9q34 t(9;22)
◦PTPRT 20q12/MYBL2 20q13.12 (20q)

◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x5)

Chronic Myelogenous Leukemia (CML) FISH Panel FISH

•Disease(s):  Chronic myelogenous leukemia, including abnormalities associated with progression to accelerated and blast phase •Probes:
◦MYC 8q24/CEP8 8p11.1/IGH 14q32 t(8;14)
◦ABL1 9q34/BCR 22q11.2/ASSI 9q34 t(9;22)
◦p53 17p13/ATM 11q22.3
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x3)

Chronic Lymphocytic Leukemia (CLL) FISH Panel FISH

•Disease(s): Chronic lymphocytic leukemia (prognostic abnormalities)
•Probes:
◦CCND1 11q.13/IgH 14q32.3 t(11;14)
◦p53 17p13/ATM 11q22.3
◦MDM2 12q15/D12Z1 12p11.1-q11.1 (+12)
◦D13S319 13q14.2/13qter 13q34 (del13q)
◦RB1 13q14.2/13qter 13q34 (RB1)
◦IGHC 14q32.3/IGHV 14q32.3 (IGH BAP)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x6)

Acute Myelogenous Leukemia (AML) FISH Panel FISH

•Disease(s):  Acute myeloid leukemia
•Probes:
◦EGR1 5q31.2/TASR1 5p15.31 (5q)
◦RELN, ORC5L 7q22/TES 7q31 (7q)
◦MYC 8q24/CEP8 8p11.1-q11.1 (CEP8)
◦RUNX1T1 8q21.3/RUNX1 21q22 t(8;21)
◦MLL 11q23 (MLL)
◦CBFB 16q22 (CBFB)
◦PML 15q24.1/RARA 17q21 t(15;17)*
◦Probes may be ordered separately

*Probe set used only there is suspicion for APL based on morphologic/flow cytometric evaluation

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x6); with Reflex 88377(x7)

Acute Lymphocytic Leukemia (ALL) (Adult) FISH Panel FISH

•Disease(s): B-lymphoblastic leukemia (adult patients)
•Probes:
◦BCR/ABL1/ASS1 t(9;22)
◦MLL (11q23)
◦p16/D9z3 (p16)
◦CMYC 8q24 t(8;14)
◦Probes may be ordered separately

•Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
•Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
•Fresh, Unfixed Tissue: Tissue in RPMI.
•Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
•Fluids: Equal parts RPMI to specimen volume.
•Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88377(x4)

TERC FISH FISH

Disease: The cervical TERC FISH Test evaluates for cervical cells for chromosomal abnormalities (TERC gene amplification, increase in chromosome copy number) linked to cervical cancer. Studies have shown that at lease 90% of invasive cervical cancer cases have increased copy numbers of the telomerase gene (TERC), located at 3q26.2.

Probes: TERC (3q26)/5p15/Copy Control 7/CDKN2A

Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days

Click here to reference the specimen rejection criteria.

3-7 Days

88368x1, 88369x1

TMPRSS2:ERG Fusion FISH

Disease: A genetic mutation seen in up to 50 percent of prostate cancers, in which the androgen-regulated gene TMPRSS2 is fused with the gene for the transcription factor ERG.

Probes: ERG/HMGN1/DSCAM/ TMPRSS2 at 21q22.2

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each FISH test ordered.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

3 - 7 Days

88377

PTEN FISH FISH

Disease: Loss of PTEN in prostatic adenocarcinoma is associated with biochemical recurrence, advanced tumor stage, high Gleason grade, and lymph node metastasis.

Probes: CEP10/PTEN/WAPAL/FAS at 10q23.31

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each FISH test ordered.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

3 - 7 Days

88377

Bladder FISH FISH

Disease: Transitional cell carcinoma of bladder is frequently associated with chromosomal alterations, including chromosomes 1, 3, ,5, 7, 9, 10, 17, and others, which may be detected with high sensitivity and specificity by FISH in exfoliated urothelial cells from urine samples. Results of the test are intended for use, in conjunction with current standard diagnostic procedures such as cystoscopy and urine cytology, as an aid for initial diagnosis of bladder cancer in patients with hematuria and subsequent monitoring for tumor recurrence in patients with a history of bladder cancer.

Probes: CEP3/CEP7/CEP10/5p15.2

Voided urine mixed 2:1 (v:v) with recommended PreservCyt (Hologic)

Specimen should be stored and transported refrigerated with a cool pack.

Click here to reference the specimen rejection criteria.

3 - 5 Days

88120

TdT Flow Cytometry

Staining for terminal deoxynucleotidyl transferase (TdT) highlights normal precursor B-cells in bone marrow, tonsils and lymph nodes and normal thymocytes. TdT is expressed by the blasts in most cases of B and T-lymphoblastic lymphoma/leukemia, 10-15% of cases of acute myeloid leukemias, some mixed lineage leukemias and some non-hematopoietic neoplasms (Merkel cell carcinoma).

Testing for this antigen is typically performed as a part of the acute leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

T-cell receptor gamma/delta Flow Cytometry

Staining for TCR gamma/delta highlights a minor subset (<5%) of normal mature CD3+ T-cells in bone marrow and peripheral blood, while representing the majority of T-lymphocytes in mucosal tissues. It is also expressed by certain subtypes of mature T-cell non-Hodgkin lymphoma (e.g. hepatosplenic gamma/delta T-cell lymphoma, primary cutaneous gamma/delta T-cell lymphomas) and subsets of post-thymic T-cell lymphoma/leukemia.

Testing for this antigen is typically performed as a part of the T-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

T-cell receptor alpha/beta Flow Cytometry

Staining for TCR alpha/beta highlights the majority (>95%) of normal mature CD3+ T-cells in bone marrow and peripheral blood samples. TCR alpha/beta is also expressed on many subtypes of mature T-cell non-Hodgkin lymphomas and in a small subset of post-thymic T-cell lymphoblastic lymphoma/leukemia.

Testing for this antigen is typically performed as a part of the T-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

MYELOPEROXIDASE Flow Cytometry

Staining for cytoplasmic myeloperoxidase (MPO) highlights normal myeloid cells of neutrophil lineage at all stages of maturation (blasts to mature granulocytes), as well as subsets of monocytes. It is also expressed in the blasts of acute myeloid leukemias and some mixed lineage acute leukemias.

Testing for this antigen is typically performed as a part of the acute leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

LAMBDA Flow Cytometry

Staining for immunoglobulin lambda light chain highlights subsets of mature B-cells (by surface staining) and plasma cells (by intracytoplasmic staining), as well as the neoplastic cells in mature B-cell lymphomas and plasma cell neoplasms. The kappa:lambda ratio is used to assess these neoplasms for clonality.

Testing for this surface antigen is typically performed as a part of the leukemia/lymphoma screening panel, while testing for cytoplasmic lambda is part of the plasma cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

KAPPA Flow Cytometry

Staining for immunoglobulin kappa light chain highlights subsets of mature B-cells (by surface staining) and plasma cells (by intracytoplasmic staining), as well as the neoplastic cells in mature B-cell lymphomas and plasma cell neoplasms. The kappa:lambda ratio is used to assess these neoplasms for clonality.

Testing for this surface antigen is typically performed as a part of the leukemia/lymphoma screening panel, while testing for cytoplasmic kappa is part of the plasma cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

HLA-DR Flow Cytometry

Staining for HLA-DR highlights normal mature B-cells, activated T-cells, monocytes/macrophages, dendritic cells and CD34+ blasts. Additionally, it is expressed on the leukemic cells of acute myeloid leukemias (with the notable exception of acute promyelocytic leukemia), lymphoblastic and mixed lineage leukemia, and by neoplastic lymphoid cells in mature B-cell and T-cell lymphomas.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

FLAER Flow Cytometry

FLAER (fluorescein-labeled proaerolysin) is a bacteria-derived prototoxin which binds directly to the glycophosphatidylinositol (GPI) anchor in the membrane of leukocytes. It is used in the flow cytometric assessment for paroxysmal nocturnal hemoglobinuria (PNH), as a direct measurement of GPI expression on granulocytes and monocytes.

Testing for this antigen is typically performed as a part of the PNH analysis. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

FMC7 Flow Cytometry

Staining for FMC7 highlights a subset of mature B-lymphocytes, which represent >50% of peripheral blood B-lymphocytes in adults. FMC7 antibodies actually highlight an epitope present on the extracellular domain of the CD20 molecule, which is detected variably at different stages of B-cell maturation due to sensitivity of the specific antibodies to the variable levels of membrane cholesterol characteristic for these stages of maturation. FMC7 is detected on many mature B-cell lymphomas/leukemias and is characteristically absent in CLL/SLL with classic immunophenotype, which also shows decreased expression of CD20.

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD235A Flow Cytometry

Staining for CD235a (Glycophorin A) detects erythroid precursors and erythrocytes and is also expressed by the neoplastic blasts in rare acute erythroblastic leukemias. In our laboratory it is used for delineating the erythrocytes in the analysis for paroxysmal nocturnal hemoglobinuria.

Testing for this antigen is typically performed as a part of the PNH analysis. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD138 Flow Cytometry

Staining for CD138 highlights precursor B-cells (hematogones) and mature plasma cells. It is also typically expressed in plasma cell neoplasms (MGUS, myeloma).

Testing for this antigen is typically performed as a part of the plasma cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD117 Flow Cytometry

Staining for CD117 highlights CD34+ stem cells, myeloblasts, promyelocytes, erythroblasts, some monoblasts, megakaryoblasts and mast cells. CD117 is also expressed by the blasts in acute myeloid leukemias, some subsets of T-acute lymphoblastic leukemias (early T-precursor ALL), some mixed lineage acute leukemias, and by mast cells in systemic mastocytosis.

Testing for this antigen is typically performed as a part of the acute myeloid leukemia add-on panel and the systemic mastocytosis add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD103 Flow Cytometry

Staining for CD103 may highlight subsets of activated T-cells, monocytes and mast cells. It is also aberrantly expressed by neoplastic B-cells in hairy cell leukemia and splenic B-cell lymphoma/leukemias.

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD81 Flow Cytometry

Staining for CD81 highlights leukocytes and normal plasma cells. It is most often used in the diagnostic work-up of plasma cell neoplasms, where complete or partial loss of CD81 expression is a common finding.

Testing for this antigen is typically performed as a part of the plasma cell neoplasm ad-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD79b Flow Cytometry

Staining for CD79b detects normal B-cells at all stages of maturation associated with expression of surface immunoglobulin. Staining for this antigen is used in panels of antibodies used to characterize B-cell neoplasms, as it is often lost as a part of the aberrant B-cell phenotypes seen in this context (e.g. it is often negative in classic CLL/SLL).

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD64 Flow Cytometry

Staining for CD64 detects subsets of normal mature granulocytes and monocytes at all stages of maturation. Increased expression of CD64 on neutrophils correlates with sepsis. CD64 expression is also present in most acute myeloid leukemias and some precursor B lymphoblastic leukemias.

Testing for this antigen is typically performed as a part of acute myeloid leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD59 Flow Cytometry

Staining for CD59 detects hematopoietic cells of all lineages. CD59 is a GPI anchor-linked protein, and it is most often used in the diagnostic work up for paroxysmal nocturnal hemoglobinuria (PNH), where loss of this CD59 expression is used to identify abnormal PNH clones in erythrocyte, monocyte and granulocyte populations.

Testing for this antigen is typically performed as a part of the PNH analysis. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD57 Flow Cytometry

Staining for CD57 detects a subset of CD8+ T-cells, T-large granular lymphocytes. It is used more often in the detection and quantitation of the latter cells in normal samples and T-large granular lymphocyte proliferations. CD57 may also be expressed by precursor T- and some precursor B-lymphoblastic lymphoma/leukemia cases.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD56 Flow Cytometry

Staining for CD56 detects normal NK cells and subsets of CD8+ cytotoxic T-cells. Partial, weak CD56 expression may also be detected in subsets of normal plasma cells and on immature myeloid and monocytic cells in regenerative (reactive) processes. CD56 expression is present on a large variety of hematopoietic neoplasms, including T-cell lymphomas, B- and T-lymphoblastic leukemia/lymphoma, NK and T-large granular lymphocyte proliferations, acute myeloid leukemias and plasma cell neoplasms (MGUS, myeloma).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD45 Flow Cytometry

Staining for CD45 detects most cells of hematopoietic origin at all stages of maturation. The combination of CD45 intensity and side-scatter is used in flow cytometry for acurate separation of the main leukocyte populations in bone marrow and peripheral blood samples, and for detection of abnormal cell populations. CD45 expression is regarded as a highly useful marker of hematopoietic lineage in staining panels for poorly differentiated neoplasms. However, some hematopoietic neoplasms may be negative for CD45. These include myelomas, some plasmablastic lymphomas, some acute myeloid and lymphoblastic leukemia cases, and some cases of T-anaplastic large cell lymphoma.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD38 Flow Cytometry

Staining for CD38 detects normal plasma cells, activated T-cells and B-cells, precursor B-cells (hematogones) and progenitor cells (blasts). Most plasma cell neoplasms are strongly positive for CD38. Most acute myeloid and lymphoblastic leukemias are also positive for this antigen. CD38 expression in chronic lymphocytic lymphoma is highly correlated with unmutated IGVH genes (“unmutated CLL”) and an unfavorable prognosis.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel and the plasma cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD34 Flow Cytometry

Staining for CD34 detects progenitor cells, including stem cells, myeloid blasts and early lymphoid progenitors (“stage I hematogones”). It is also expressed by the blasts of most acute myeloid leukemias and precursor B lymphoblastic lymphoma/leukemia, and by 80-85% of cases of precursor T-lymphoblastic lymphoma/leukemia. Acute monoblastic leukemias lack CD34 expression in a large proportion of cases.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD33 Flow Cytometry

Staining for CD33 detects normal monocytes and some normal immature myeloid cells. It is often expressed by myeloblasts and monoblasts in acute myeloid leukemias, and by the blasts of some precursor B lymphoblastic lymphoma/leukemia cases and of rare cases of precursor T-lymphoma/leukemia. It is also expressed in a large subset of T-anaplastic large cell lymphomas.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD27 Flow Cytometry

Staining for CD27 detects some normal mature B-cell subsets (germinal center and memory B-cells), plasma cells, T-cells and NK cells. It is most often used in the diagnostic work-up of plasma cell neoplasms, where loss of CD27 expression is a common finding.

Testing for this antigen is typically performed as a part of the plasma cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD25 Flow Cytometry

Staining for CD25 (TAC, IL-2 receptor alpha chain) detects activated B-cells, T-cells and monocytes. CD25 is strongly expressed by hairy cell leukemia cells and variable expression may also be present in other B-cell lymphomas and T-cell lymphomas (most characteristically HTLV-related adult T-cell lymphoma/leukemia). Aberrant expression of CD25 is seen in on mast cells in systemic mastocytosis.

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel and the systemic mastocytosis add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD24 Flow Cytometry

Staining for CD24 detects mature granulocytes and normal mature and immature B-cells at all stages of maturation. It is also expressed in most mature B-cell and B-lymphoblastic neoplasm. In our laboratory this marker is used for defining (gating on) the mature granulocytes to assess for antigen loss as a part of the PNH analysis.

Testing for this antigen is typically performed as a part of the PNH analysis. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD23 Flow Cytometry

Staining for CD23 detects subsets of peripheral blood mature B-lymphocytes and some B-cell found in the mantle zone of the B-lymphoid follicles and normal follicular dendritic cells. It is expressed by some B-cell neoplasms (e.g. chronic lymphocytic leukemia, hairy cell leukemia, marginal zone lymphoma).

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD22 Flow Cytometry

Staining for surface CD22 detects normal mature and immature B-cells and normal basophils. It is also expressed at variable intensity by most mature B-cell non-Hodgkin lymphoma and precursor B-lymphoblastic lymphoma/leukemia, as well as in some mixed lineage acute leukemias (B-lymphoid/myeloid), which may show mostly cytoplasmic expression of this antigen.

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. Cytoplasmic staining for CD22 is also performed as a part of acute leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD20 Flow Cytometry

Staining for CD20 detects mature B-cells and precursor B-cells at some stages of maturation. It is also expressed at variable intensity in most mature B-cell non-Hodgkin lymphomas, many cases of precursor B lymphoblastic lymphoma/leukemia (typically weak and variable in the latter), and some myelomas [characteristically myeloma with t(11;14)]. While regarded as a highly specific B-lineage associated marker, it has been rarely found in some mature T-cell lymphomas and carcinomas. Notably, any of these B-cell neoplasms may become CD20-negative following therapy with agents targeting CD20 (e.g. Rituximab).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD19 Flow Cytometry

Staining for CD19 detects normal mature and immature B-cells at all stages of maturation, and most normal plasma cells. CD19 is also expressed in most mature B-cell non-Hodgkin lymphomas, precursor B-cell lymphoblastic lymphoma/leukemia and by the myeloblasts of some acute myeloid leukemias [most characteristically, AML with t(8;21)]. The loss of CD19 expression is a part of the abnormal immunophenotype of a large proportion of plasma cell neoplasms (including MGUS and myeloma).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD16 Flow Cytometry

Staining for CD16 detects mature granulocytes, myeloid precursors, subsets of activated monocytes, NK cells and subsets of CD8+ T-cells. CD16 expression is also present in abnormal NK cell proliferations including NK cell leukemias. CD16 is a GPI-anchored protein. The complete or partial loss of CD16 expression on mature granulocytes is characteristic for paroxysmal nocturnal hemoglobinuria (PNH).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD15 Flow Cytometry

Staining for CD15 detects mature granulocytes and immature myeloid cells (excluding CD34+ blasts), as well as mature and immature monocytes. It may also be expressed by the leukemic blasts of some acute myeloid leukemia (AML). As co-expression of CD15 and CD34 is abnormal, this combination of markers may be used for minimal disease detection in AML.

Testing for this antigen is typically performed as a part of the acute myeloid leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD14 Flow Cytometry

Staining for CD14 is used mainly to detect normal mature monocytes. It is also expressed at low levels by a subset of granulocytes and immature myeloid cells. Additionally, it may be expressed at variable levels on leukemic monocytes in some acute myeloid leukemias with monocytic differentiation.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD13 Flow Cytometry

Staining for CD13 detects mature granulocytes, myeloid precursors at all stages of maturation, mature and immature monocytes. It is also expressed by acute myeloid leukemias, a large proportion of precursor B-cell acute lymphoblastic leukemias, and a significant proportion of anaplastic large cell lymphomas.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD11c Flow Cytometry

Staining for CD11c detects mature granulocytes, myeloid precursors (excluding CD34+ blasts) and mature and immature monocytes. CD11c is also expressed by acute myeloid leukemias, some precursor B-lymphoblastic leukemias, some T-anaplastic large cell lymphomas, and some mature B-cell neoplasms (hairy cell leukemia, hairy cell leukemia variant, splenic B-cell lymphoma, marginal zone lymphoma.

Testing for this antigen is typically performed as a part of the B-cell neoplasm add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD11b Flow Cytometry

Staining for CD11b detects mature granulocytes, myeloid precursors (excluding CD34+ blasts) and monocytes. Abnormal CD11b expression may be seen on myeloid blasts of some acute myeloid leukemias, on lymphoid blasts of precursor B lymphoblastic leukemias and precursor T-lymphoblastic leukemias, and in a large proportion of T- anaplastic large cell lymphomas. As co-expression of CD11b and CD34 is abnormal, this combination of markers may be used for minimal disease detection in AML.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD10 Flow Cytometry

Staining for CD10 highlights normal precursor B-cells (“hematogones”), mature B-cells found in benign germinal centers and mature granulocytes. It is also expressed at variable intensity in B-cell neoplasms including follicular lymphoma, Burkitt lymphoma, diffuse large B-cell lymphoma, and precursor B-cell lymphoblastic lymphoma/leukemia. It is also expressed by the neoplastic T-cells in angioimmunoblastic T-cell lymphoma.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD8 Flow Cytometry

Staining for CD8 detects a normal T-cell subset (cytotoxic). It is also expressed at normal or abnormal levels by some mature T-cell non-Hodgkin lymphomas, T-large granular lymphocyte leukemias, and many T-lymphoblastic lymphoma/leukemias (where it is often co-expressed with CD4).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD7 Flow Cytometry

Staining for CD7 detects normal T-lymphocytes, NK cells and thymocytes. It is also expressed at normal or abnormal levels by most mature T-cell non-Hodgkin lymphomas and precursor T-cell lymphoblastic lymphomas/leukemias.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD5 Flow Cytometry

Staining for CD5 detects normal T-lymphocytes. It is also expressed at normal or abnormal levels by most mature T-cell non-Hodgkin lymphomas and precursor T-cell lymphoblastic lymphomas/leukemias. Dim CD5 expression may be found on some normal B-cell subsets. Additionally, CD5 expression is characteristically present in some subsets of B-cell non-Hodgkin lymphoma, including chronic lymphoid leukemia/small lymphocytic lymphoma, mantle cell lymphoma and less commonly, some marginal zone lymphomas and lymphoplasmacytic lymphomas.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD4 Flow Cytometry

Staining for CD4 detects a normal T cell subset (helper/inducer) and is also expressed at lower levels by normal mature and immature monocytes, and by myeloid precursors at the promyelocyte/myelocyte stage. It is also present on normal thymocytes where it may be co-expressed with CD8. The antibody is also expressed on some mature T-cell lymphomas (e.g. anaplastic large cell lymphomas, mycosis fungoides and some peripheral T-cell lymphomas,NOS) and in many of T-lymphoblastic lymphoma/leukemias (where it is often co-expressed with CD8).

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD3 Flow Cytometry

Staining for surface CD3 detects normal T-lymphocytes and is an ideal marker of normal mature T-cell enumeration in blood and marrow samples. Surface CD3 is also expressed at normal or abnormal levels by most mature T-cell non-Hodgkin lymphomas and some precursor T-cell lymphoblastic lymphomas/leukemias. Cytoplasmic CD3 expression is present in all T-lymphoblastic lymphomas/leukemis and in some mixed lineage (T-lymphoid/myeloid) acute leukemias.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel. Cytoplasmic CD3 is also performed as a part of the acute leukemia add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

CD2 Flow Cytometry

Staining for CD2 detects normal T-lymphocytes and NK cells. It is also expressed at normal or abnormal levels by most mature T-cell non-Hodgkin lymphomas and precursor T-cell lymphoblastic lymphomas/leukemias. Abnormal CD2 expression also occurs on monocytes in some acute myeloid leukemias and on mast cells in systemic mastocytosis.

Testing for this antigen is typically performed as a part of the leukemia/lymphoma screening panel and the systemic mastocytosis add-on panel. For customized testing panels including this antigen, please contact the Medical Director of the Flow Cytometry laboratory.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184, 88185, 88187, 88188, 88189

High Sensitivity PNH Evaluation   Flow Cytometry

Markers are CD14, CD15, CD24, CD45, CD59, CD64, CD235a (Glycophorin A), and FLAER. The sensitivity of this assay is 0.01% for granulocyte and monocyte PNH clones and 0.01-0.1% for RBC PNH clones. This assay is consistent with the most recent International Clinical Cytometry Society (ICCS) Guidelines.

•Peripheral blood: 5 ml (1-2 mL minimum) EDTA or sodium heparin tube. Please provide recent CBC report. Bone marrow specimens are not acceptable.

Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

24 hours

88184(x1), 88185(x7), 88187(x1)

ThinPrep Pap Test Cervical Cytology

Liquid based Pap testing is intended fo ruse in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda system for reporting results of cervical cytology. Pap screening is not reliable for the detection of endometrial cancer.

Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days

Click here to reference the specimen rejection criteria.

1 - 3 Days

88175 which includes imaging, or 88142 if requires a manual screen with no imaging. Pap results requiring physician interpretation will be performed at an additional charge using CPT Code: 88141.

Colonic Brushing Cytology Cervical Cytology

Cytopathologic evaluation to establish the presence of primary or metastatic neoplasm and to aid in the diagnosis of certain infections, such as amebiasis, giardiasis, and strongyloidiasis.

Brush lesion area. Place brush directly into CytoLyt, swirl the brush vigorously in the solution, then snip into the container. Submit with an appropriately completed requisition, including pertinent patient history.

Store in CytoLyt solution. Refrigerate specimens that cannot be delivered immediately and deliver as soon as possible.

Click here to reference the specimen rejection criteria.

2- 3 Days

88112

Esophageal Brushing Cytology Cytology

Cytopathologic evaluation to establish the presence of primary or metastatic neoplasm and to aid in the diagnosis of certain infections such as Herpes virus, Candida, and certain benign conditions such as Barrett’s esophagus.

Brush lesion area. Place brush directly into CytoLyt, swirl the brush vigorously in the solution, then snip into the container. Submit with an appropriately completed requisition, including pertinent patient history.

Store in CytoLyt solution. Refrigerate specimens that cannot be delivered immediately and deliver as soon as possible.

Click here to reference the specimen rejection criteria.

2- 3 Days

88112

Non-Gyn Cytology Cytology

Cytopathologic evaluation for the detection and characterization of malignant cells and some nonneoplastic neoplasms.

Brush lesion area. Place brush directly into CytoLyt, swirl the brush vigorously in the solution, then snip into the container. Submit with an appropriately completed requisition, including pertinent patient history.

Store in CytoLyt solution. Refrigerate specimens that cannot be delivered immediately and deliver as soon as possible.

Click here to reference the specimen rejection criteria.

2- 3 Days

88112

Vaginosis Panel PCR

This assay utilizes DNA extraction followed by multiplex PCR and automated microcapillary electrophoresis for the dection and identification of the causative agents for vaginitis: Candida species, Gardnerella vaginalis, and Trichomonas vaginalis.

Cervical or vaginal swab collections. Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• SurePath™ Pap Vial
Please clearly label vaginal swab collections into a ThinPrep® or SurePath™ Pap Vial as VAGINAL.

Specimens can be shipped and stored at 2 - 24°C. If shipping temperatures exceeding 24°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 21 Days
• SurePath™ Pap Vial: 21 Days
• SimpleSwab™: 5 Days
• BD eSwab: 5 Days

Click here to reference the specimen rejection criteria.

3 - 5 Days

87481, 87511, 87661

Vaginosis Panel DNA Direct - BD Affirm

This assay is a nucleic acid hybridization DNA probe test for detection and identification of the causative agents for vaginitis: Candida species, Gardnerella vaginalis, and Trichomonas vaginalis.

Acceptable specimen collection/transport containers are:
• SimpleSwab™
• BD eSwab
• BD Affirm™ VPIII Ambient Temperature Transport System (ATTS) Swab.

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• BD Affirm™ VPIII Ambient Temperature Transport System (ATTS) Swab: 72 hours Preservative included in swab kit must be added to specimen vial at time of collection.
• SimpleSwab™: 5 Days
• BD eSwab: 5 Days

Click here to reference the specimen rejection criteria.

1 - 2 Days

87480, 87510, 87660

Group B Strep (GBS) DNA

This assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiaeby targeting a segment of the Streptococcus agalactiaegenome.

Vaginal and rectal sample collection should be performed in accordance with published guidelines for collection of clinical specimens for culture of Group B Streptococcus. Acceptable specimen collection/tranpsoprt containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab *

*Reflex to Penicillin Resistance and Sensitivity testing can be performed off the BD™ ESwab or SimpleSwab specimen and ordered on the WHL requisition.

Specimens can be shipped and stored at 4 - 25°C. If shipping temperatures exceeding 25°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• BD™ Liquid Amies Elution Swab (ESwab) Collection and Transport System: 48 hours
• SimpleSwab™: 4 Days
• BD eSwab: 4 Days

Click here to reference the specimen rejection criteria.

2 - 3 Days

87653

Chlamydia DNA - Roche Cobas

This assay is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT). Testing is also available in combination with gonorrhea detection.

Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• COBAS® PCR Female Swab Sample Kit
• COBAS® PCR Urine Sample Kit

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:
• ThinPrep® Pap Vial: 30 days
• COBAS® PCR Female Swab Sample Kit: 30 days
• COBAS® PCR Urine Sample Kit: 30 days
• SimpleSwab™: 10 Days
• BD eSwab: 10 Days

Click here to reference the specimen rejection criteria.

2 - 4 Days

87491

Chlamydia RNA - Hologic Panther

This assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT). Testing is also available in combination with gonorrhea detection.

Acceptable specimen collection/transport containers are:
• ThinPrep® Pap Vial
• SimpleSwab™
• BD eSwab
• APTIMA® Specimen Transfer Tube containing 1 ml of ThinPrep® or SurePath™ Pap Vial contents (vortex vial before transfer)
• APTIMA® Unisex Swab
• APTIMA® Vaginal Swab
• APTIMA® Urine Transport Tube

Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool plack. Viability after transfer to collection/transport tube is:

• ThinPrep® Pap Vial: 30 days
• APTIMA® Specimen Transfer Tube: 14 days containing SurePath™ aliquot, 30 days containing ThinPrep® aliquot
• APTIMA® Unisex Swab: 30 days
• APTIMA® Vaginal Swab: 30 days
• APTIMA® Urine Transport Tube: 30 days
• SimpleSwab™: 10 Days
• BD eSwab: 10 Days

Click here to reference the specimen rejection criteria.

2 - 4 Days

87491

ABL1 Kinase Domain Mutation Analysis Molecular Genetics

RT-PCR and sequencing of the BCR-ABL 1 fusion transcript for qualitative detection of mutations associated with resistance to imatinib and other tyrosine kinase inhibitors. Analysis includes detection of the common T315I mutation.

• Peripheral blood: 4 mL in EDTA tube.
• Bone marrow: 2 mL in EDTA tube.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Click here to reference the specimen rejection criteria.

10 Days

81401

Iron Special Stains

Iron Stain Kit is used to identify iron pigment in tissue sections on the Artisan™ Link and Artisan™ Link Pro Staining Systems. Iron is an important component of the human body, especially as a vital constituent of oxygen carrying hemoglobin. Iron is stored in bone marrow, and a loss of iron stores is indicative of anemia. An excess of iron deposited in organs such as liver, spleen, and bone marrow may be a result of hemochromatosis. Ferric deposits: blue, nuclei: red, and the background tissue elements are stained pink. This stain is not recommended for bone marrow smears.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88313

BCL-2 IHC

The BCL2 protein is strongly expressed in the cytoplasm of mantle zone B-lymphocytes and activated T-lymphocytes. It is also overexpressed as a result of t(14;18) in follicular lymphomas and a subset of aggressive B-cell lymphomas, and as a result of translocation independent overexpression in mantle cell lymphoma, CLL/SLL, subsets of marginal zone lymphomas, Hodgkin lymphoma. It is most useful in the work-up of B-cell lymphoma.

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Click here to reference the specimen rejection criteria.

2-3 Days

88341, 88342, 88360

Tissue Biopsy Histology

To determine the nature of a body lesion.

All specimen containers must be labeled with two identifiers. Examples of acceptable identifiers include: Patient name, date of birth, social security number, requisition number, and medical record number. Specimens must be submitted in formalin solution.

Maintain the specimen at room temperature.

Click here to reference the specimen rejection criteria.

1-3 Days

88302, 88304, 88305, 88307, 88309

Mixed-Lineage Leukemia (MLL) Gene Rearrangements FISH

•Disease(s): B-lymphoblastic leukemia, Acute myeloid leukemia, Mixed phenotype acute leukemias •Probes:
◦MLL (11q23)

◦Probes may be ordered separately

• Bone Marrow Aspirate: 1-3 mL sodium heparin tube. EDTA tube is acceptable.
• Peripheral Blood: 2-4 mL sodium heparin tube. EDTA tube is acceptable.
• Fresh, Unfixed Tissue: Tissue in RPMI.
• Bone Marrow Core Biopsy: 1-2cm core (length) Tissue in RPMI.
• Fluids: Equal parts RPMI to specimen volume.
• Paraffin Block or Cut Slides: Not available.

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. 

Click here to reference the specimen rejection criteria.

1-3 Days

88368x1

Urine Cytology Cytology

Cytopathologic evaluation for the detection and characterization of malignant cells and some nonneoplastic renal diseases in symptomatic patients.

40 cc freshly collected urine mixed with an equal volume of PreservCyt Solution. Please indicate source urine: voided, catherized or bladder washing

Store PreservCyt® Solution with urine specimen between 4°C and 30°C. Process sample within 48 hours.

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2 - 3 Days

88112

Standard Leukemia/Lymphoma Panel – 23 markers   Flow Cytometry

Markers are CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD16, CD19, CD20, CD33, CD34, CD38, CD45, CD56, CD57, 7AAD, HLA-DR, surface kappa, and surface lambda. Additional markers may be added if initial screen is abnormal.

"•Bone marrow aspirate or peripheral blood: 5 ml (1-2 ml minimum), EDTA or sodium heparin tube. Please provide recent CBC report. •Bone marrow core: 1-2 cm minimum core length in RPMI.
•Fresh, unfixed tissue: Submit specimen in RPMI.
•Fluids and FNAs: Equal parts RPMI and specimen.
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Maintain specimen at room temperature. Do not refrigerate or freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

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24 hours

88184(x1), 88185(x22), 88189(x1). Additional 88185 CPTs may be added if initial screen is abnormal.

Constitutional Cytogenetics Cytogenetics

Standard chromosome analysis performed on cultured fetal or placental cells.

•Fresh/Unfixed Tissue – Products of Conception (POC): Dissected chorionic villi or known fetal tissue(s) are preferred, but uterine contents or tissue of mixed fetal/maternal origin is acceptable and will be processed. Please include villi if sending tissue from a fetal demise. Place tissue in RPMI, note type(s) of tissue on test requisition. ◦POC cytogenetics only: At least 50-100 mg villi or 1-1.5 cm3 fetal tissue(s). ◦POC cytogenetics with reflex to NeoARRAY™ SNP/Cytogenetic Profile: Same. At least 50-100 mg villi or 1-1.5 cm3 fetal tissue(s).

Refrigerate specimen. Do not freeze. Use cold pack for transport, make sure cold pack is not in direct contact with specimen.

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POC cyto w/o array: 7-21 days, POC cyto w/array : 21-35 days

88233, 88262, 88291

Cancer Cytogenetics Cytogenetics

A wide variety of abnormalities can be identified, providing both diagnostic and prognostic information. Acute leukemias, lymphomas and chronic myeloid and lymphoid disorders are examined cytogenetically in order to establish the exact nature of the acquired genetic change. Rearrangements, also known as translocations, inversions, and deletions, can usually be detected under a light microscope. In most leukemias and lymphomas, changes in chromosome number (ploidy) or chromosome structure (rearrangements) are often observed. 

"•BM Aspirate: 1-3 mL sodium heparin tube. •Peripheral Blood: 2-4 mL sodium heparin tube.
•Fresh/Unfixed Tissue - Lymph Node/Tissue Biopsy: One thin cross-section of fresh node or one representative section of solid tumor with minimum 0.5 cm3 tissue. Collect under sterile conditions as if for microbiologic culture. Place tissue in RPMI, note type(s) of tissue on test requisition.
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Refrigerate specimen. Do not freeze. Use cold pack for transport, make sure cold pack is not in direct contact with specimen.

Click here to reference the specimen rejection criteria.

BM aspirate/blood cyto: 3-5 days, Lymph node/biopsy cyto: 3-21 days

88237, 88239, 88264, 88291

Methodology Test Name Test Description Specimen Requirements Storage and Transport Specimen Rejection Criteria Turn Around Time (TAT) CPT Codes*

*The CPT codes provided with our Test Descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.