Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance

Test Code

92447

CPT Codes
87902

Includes

HCV NS5a Subtype
Daclatasvir Resistance
Ledipasvir Resistance
Ombitasvir Resistance
Elbasvir Resistance
Velpatasvir Resistance

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 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 (SST) 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: 42 days

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

Gross hemolysis • Grossly lipemic • Specimens collected using heparin as 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

Set up: Mon, Wed-Sat; Report available: 3-4 days

Reference Range

See Laboratory Report

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.

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.