Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance

Test Code

90924

CPT Codes
87902

Preferred Specimen

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

Minimum Volume

0.6 mL

Other Acceptable Specimens

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

Instructions

Separate plasma or serum from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transfer the plasma to a properly identified, sterile polypropylene screw-cap vial and ship frozen.

Note: HCV genotype 1 is required for this test.

Transport Temperature

Frozen

Specimen Stability

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

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

Gross hemolysis • Grossly lipemic • Specimens using heparin as the anticoagulant

Methodology
Polymerase Chain Reaction (PCR) • 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

A.M. Sets up 1 day a week.

Clinical Significance

This assay may be used to detect grazoprevir, simeprevir and paritaprevir resistance-associated NS3 mutations in genotype 1 NS3 protease inhibitor treatment-experienced patients and also the Q80K polymorphism in patients being considered for a simeprevir-containing regimen.

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.