Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance

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.

Specimen Requirements

2.0 mL Plasma from a Lavender Top Tube - EDTA in a Plastic Vial

Alternate Specimen

1.0 mL Serum from a Red Top Tube in a Plastic Vial

TransportAndStorage

72 hours Refrigerated
42 days Frozen (Transport)

Collection Instructions

Separate plasma (preferred) 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, polyproprylene screw-cap vial and ship refrigerated or frozen. 

Please note: HCV genotype 1 is required for this test.

Reference Range:

Refer to Interpretive Results

Methodology:

• Polymerase Chain Reaction (PCR) Sequencing

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.

CDM

00913957

CPT Coding

87903