Hepatitis C Virus RNA Genotype with Reflex to HCV NS5a Drug Resistance

Test Code

93871

Alias/See Also

LAB123593871

Includes

If Hepatitis C Virus RNA Genotype 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

Separate plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a transport tube and refrigerate or freeze.

Serum is collected in a serum separator tube or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.

Transport Container

Transport tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 30 days

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

Gross hemolysis • Grossly lipemic • Unspun PPT tube • Specimens collected using heparin as anticoagulant

Methodology
Real-Time Polymerase Chain Reaction • Sequencing

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 7 days

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. A concurrent patient HCV viral load of ≥2000 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.