Hepatitis C Virus (HCV) GT1a NS5A Profile
Use
The HCV GT1a NS5A profile is intended for baseline determination of HCV viral load, HCV genotype, and HCV NS5A drug resistance in patients with documented HCV infection and HCV genotype 1a. HCV quantitative RT PCR: Determine the number of international units (IU) of hepatitis C virus (HCV) RNA per milliliter in serum or plasma in known HCV-positive patients. HCV genotyping: Genotyping of the six major HCV types and their most common subtypes. HCV NS5A drug resistance assay: Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5A inhibitors. Detects resistance associated variants at positions 28, 30, 31, and 93 in genotype 1a HCV.
Special Instructions
Not provided.
Limitations
HCV quantitative RT PCR: The quantifiable range of the assay is 15 IU/mL to 100,000,000 IU/mL. HCV genotyping may not be successful when the HCV viral load is <1000 IU/mL serum/plasma. The HCV NS5A drug resistance assay may not be successful when the HCV viral load is <500 IU/mL.
Methodology
HCV quantitative RT PCR: Cobas® AmpliPrep/Cobas® TaqMan® HCV Test v2.0; HCV genotyping: Polymerase chain reaction (PCR) amplification and solid-phase electrochemical detection; HCV NS5A drug resistance assay: Polymerase chain reaction (PCR) amplification and DNA next generation sequencing (NGS)
Biomarkers
LOINC Codes
- 50023-1 - HCV RNA Pnl SerPl NAA+probe
- 11011-4 - HCV RNA SerPl NAA+probe-aCnc
- 38180-6 - HCV RNA SerPl NAA+probe-Log IU
Result Turnaround Time
13-21 days
Related Documents
For more information, please review the documents below
Specimen
Unknown
Volume
Not provided
Minimum Volume
Not provided
Causes for Rejection
Hemolysis; green-top (heparin) tube; specimen not frozen on date of collection; PPT™ not centrifuged; specimen received in "pop-top" or "snap-cap" tube; specimen shipped at room temperature
Other tests from different labs that may be relevant