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Hepatitis C Viral RNA Genotype,LiPA with Reflex to HCV NS5a Drug Resistance
Test Code93871
CPT Codes
87902
Includes
If Hepatitis C Viral Genotype, LiPA is GENOTYPE 1 or GENOTYPE 1a, then Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge (CPT code(s): 87902).
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
1.2 mL
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
Instructions
Freshly drawn specimens (whole blood) may be stored at 2-25° C for up to 24 hours prior to centrifugation.
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
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?)
Unspun PPT tube • Whole blood samples >24 hours old • Frozen whole blood • Heparinized samples
Methodology
DNA Sequencing • Multi-Probe Reverse Hybridization • Polymerase Chain Reaction (PCR)
FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 6 days
Reference Range
See Laboratory Report
Clinical Significance
Determination of hepatitis C genotype is often required to select the most appropriate direct acting agent(s) (DAA) for the treatment of hepatitis C. Some DAA's are only effective for the treatment of hepatitis C genotype 1, whereas others may be used for additional genotypes. Refer to the package inserts of the relevant DAA's for guidance. A concurrent patient HCV viral load of >=300 IU/mL is required for this test.
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |