Hepatitis C Virus Genotypic Antiviral Drug Resistance, Serum
Use
Detecting and identifying codon substitutions in the hepatitis C virus (HCV) NS3, NS5A, and NS5B genomic regions that confer resistance to current direct-acting antiviral drugs used for treatment of chronic hepatitis C infection due to HCV genotype 1a, 1b, or 3 (any subtype). This test can guide the initiation or change of antiviral drug combinations for the treatment of chronic HCV infection. It is not intended as a screening test for HCV infection and should not be ordered for infection due to genotypes 2, 4, 5, or 6.
Special Instructions
Testing is successful only if there is sufficient hepatitis C viral (HCV) RNA present in the serum specimen (i.e., 5000 IU/mL or above) within the preceding 30 days. If the HCV RNA level is unknown or not provided, the test will be canceled. Ship specimen frozen on dry ice.
Limitations
The assay is not a direct measure of antiviral drug resistance. Although it can detect resistance-associated substitutions (RAS) in relevant HCV genomic regions, the clinical significance of these RAS requires careful interpretation. Presence of inhibitory substances in the specimen can lead to test failure. A minimum of 5000 IU/mL of HCV RNA is required for target sequence amplification and RAS detection.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
LOINC Codes
- 82525-7
- 77202-0
- 92731-9
- 73654-6
- 82701-1
- 82532-2
- 73661-3
- 73662-1
Result Turnaround Time
4-14 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2.5 mL
Minimum Volume
1.6 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions and aliquot serum into a plastic vial. Red-top tubes are not acceptable.
Storage Instructions
Ship specimen frozen on dry ice.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 60 days |