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Hepatitis C Viral RNA Genotype 1 NS5b Drug Resistance
Test Code92204
CPT Codes
87902
Includes
HCV NS5b Subtype and Sofosbuvir Resistance
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
0.6 mL
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
Instructions
Separate plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a plastic, screw-cap vial and refrigerate or freeze. Serum is collected in a serum separator tube SST® or red-top tube (no gel). Transfer to a plastic screw-cap vial and refrigerate or freeze.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 42 days
Refrigerated: 14 days
Frozen: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Specimens collected using heparin as anticoagulant
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues; Report available: 4-11 days
Reference Range
See Laboratory Report
Clinical Significance
For detection of mutations in the Genotype 1 NS5b gene associated with resistance to nucleotide analog NS5b polymerase inhibitors (example: sofosbuvir, a nucleotide analog inhibitor of HCV NS5b polymerase).
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
