Hepatitis C Virus (HCV) GenoSure NS3 and NS4A
Also known as: HCV NS3/4A
Use
This test is intended for use in patients with viral loads equal to or greater than 2,000 copies/mL. It is specifically recommended for patients with HCV genotype 1 prior to initiating simeprevir therapy. The test identifies the Q80K polymorphism which can significantly impact sustained virologic response in HCV GT 1a infected patients under specific treatment regimens.
Special Instructions
The procedure is specifically recommended for HCV genotype (subtype) 1a or 1b with a viral load greater than 2000 IU/mL.
Limitations
This assay should not be used to establish or confirm the HCV genotype. It is not suitable for samples with a viral load below 2000 IU/mL. Naturally occurring polymorphisms and treatment-emergent variants can affect treatment outcomes, and the presence of resistance-associated variants does not serve as the sole criterion for patient management.
New York Approved
Methodology
NGS
Biomarkers
LOINC Codes
- 32286-7
- 32286-7
- 77202-0
Result Turnaround Time
14-24 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
2 mL
Minimum Volume
1 mL
Container
ARUP standard transport tube
Collection Instructions
Separate from cells within 6 hours of collection and freeze immediately.
Storage Instructions
Critical Frozen.
Causes for Rejection
Thawed specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | 2 weeks |
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