Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing
Also known as: HCV NS5A
Use
This test is used to detect resistance-associated substitutions (RAS) in the NS5A region of Hepatitis C virus (HCV) genotypes 1a and 1b. It is recommended for use before initiating treatment with NS5A inhibitors, though not before confirming the HCV screening and genotype 1a or 1b positive test. The test is important for guiding therapeutic decisions in managing HCV infection and helps tailor treatment strategies to improve clinical outcomes.
Special Instructions
Order this test before initiating treatment with NS5A inhibitors. Do not order this test unless there is a positive molecular confirmation of Hepatitis C virus (HCV) screening and genotype confirmation, specifically for genotypes 1a or 1b. Timely separation of specimen from cells (ASAP or within 24 hours) is critical for accuracy.
Limitations
The assay may not detect resistance-associated substitutions (RAS) present in viral subpopulations below 20%. Additionally, the test may be unsuccessful if the HCV RNA viral load is less than log 3.4 or 2500 IU/mL, or if the HCV RNA genotype is not type 1a or 1b. Factors such as low viral load, PCR inhibitors, or viral genetic variation may lead to indeterminate results.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 82512-5
- 82380-7
Result Turnaround Time
10-13 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL
Container
ARUP standard transport tube
Collection Instructions
Separate from cells ASAP or within 24 hours of collection. Transfer serum to an ARUP standard transport tube.
Storage Instructions
Frozen.
Causes for Rejection
Heparinized specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | 72 hours |
| Frozen | 4 months |