*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*
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

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

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.