Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance

Overview

  • EPIC Code:
  • LAB3008
  • Soft Test Code:
  • HCV5A
  • Send Out Test Code:
  • 92447
Alternate Names
  • HCV Genotype 1 NS5a
  • HCV Gentotype 1 NS5A
  • Hep C Viral RNA Genotype 1NS5a Drug Restistance
Included Tests

HCV NS5a Subtype; Daclatasvir Resistance; Ledipasvir Resistance; Ombitasvir Resistance


Clinical Significance

For detection of mutations in the NS5a gene associated with resistance to NS5a inhibitors (examples: daclatasvir, ledipasvir, ombitasvir, elbasvir and velpatasvir). Testing for NS5a resistance-associated variants prior to initiation of treatment with elbasvir plus grazoprevir in HCV genotype 1a infected patients is recommended.


Specimen Collection & Preparation

Specimen Requirements

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


Transport And Storage

72 hours Ambient
14 days Refrigerated (transport)
42 days Frozen


Collection Instructions

Separate plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a plastic screw-cap vial and refrigerate or freeze.


Minimum Volume

0.6 mL Plasma


Neonatal Volume

Clinical Interpretation

Reference Range:

Not Detected


Methodology:
  • Polymerase Chain Reaction (PCR) Sequencing
Clinical Significance

For detection of mutations in the NS5a gene associated with resistance to NS5a inhibitors (examples: daclatasvir, ledipasvir, ombitasvir, elbasvir and velpatasvir). Testing for NS5a resistance-associated variants prior to initiation of treatment with elbasvir plus grazoprevir in HCV genotype 1a infected patients is recommended.


Documentation

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.


Production Schedule

Days Performed
Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Departments
  • Sendouts - Clinical
Turn Around Time

2 to 4 days


Coding & Compliance

CDM

00913956


CPT Coding

87902