Hepatitis C Viral RNA Genotype 1 NS5b Drug Resistance
Also known as: NS5b Drug Resistance
Use
This test is intended to detect mutations in the NS5B region of hepatitis C virus genotype 1 that confer resistance to polymerase inhibitors (such as sofosbuvir). It is designed for clinical decision-making to assess drug susceptibility in HCV-infected patients, particularly genotype 1a or 1b individuals.
Special Instructions
This is a send‑out test (set up typically on Tuesdays) performed at Quest Diagnostics Infectious Diseases lab and Mayo Medical Laboratories; requires prior HCV genotype determination (genotype 1) before ordering.
Limitations
This assay is limited to genotype 1 and does not determine HCV genotype; protein resistance mutations outside NS5B are not evaluated. The test is not FDA‑cleared or approved; analytic performance has been validated under CLIA. Specimens collected in heparin are unacceptable; hemolyzed or lipemic specimens may interfere with accuracy.
New York Approved
Methodology
PCR-based (Sequencing)
Biomarkers
Result Turnaround Time
5-10 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
2 mL
Minimum Volume
0.6 mL
Container
EDTA (lavender‑top) tube
Collection Instructions
Separate plasma from whole blood within 24 hours of collection by centrifugation; transfer to transport tube and refrigerate or freeze.
Storage Instructions
Refrigerate or freeze.
Causes for Rejection
Gross hemolysis; gross lipemia; specimens collected using heparin as anticoagulant
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 14 days |
| Frozen | 42 days |