Hepatitis C Viral RNA Genotype,LiPA with Reflex to HCV NS5a Drug Resistance

Test Code

93871

CPT Codes
87902

Includes

If Hepatitis C Viral Genotype, LiPA is GENOTYPE 1 or GENOTYPE 1a, then Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge (CPT code(s): 87902).

Preferred Specimen

3 mL plasma collected in an EDTA (lavender-top) tube

Minimum Volume

1.2 mL

Other Acceptable Specimens

Plasma collected in: PPT potassium EDTA (white-top) tube • Serum

Instructions

Freshly drawn specimens (whole blood) may be stored at 2-25° C for up to 24 hours prior to centrifugation.
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 42 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Unspun PPT tube • Whole blood samples >24 hours old • Frozen whole blood • Heparinized samples

Methodology
DNA Sequencing • Multi-Probe Reverse Hybridization • Polymerase Chain Reaction (PCR)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

Determination of hepatitis C genotype is often required to select the most appropriate direct acting agent(s) (DAA) for the treatment of hepatitis C. Some DAA's are only effective for the treatment of hepatitis C genotype 1, whereas others may be used for additional genotypes. Refer to the package inserts of the relevant DAA's for guidance. A concurrent patient HCV viral load of >=300 IU/mL is required for this test.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.