Test Name: Harmony Non-Invasive Prenatal Testing (NIPT)

Methodology: Molecular Genetics

Test Description

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.

Specimen Requirements

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

Storage and Transport

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.

Specimen Rejection Criteria

Click here to reference the specimen rejection criteria.

Turn Around Time (TAT): 5-10 Days

CPT Codes*: 81507

*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.