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Hepatitis C Viral RNA, Genotype, LiPA
MessageQNI Test Code 37811
Test Code
HCVLIPA
Quest Code
37811
CPT Codes
87902
Preferred Specimen
2 mL plasma collected in a PPT potassium EDTA (white-top) tube or EDTA (lavender-top) tube
Minimum Volume
0.6 mL
Other Acceptable Specimens
Serum
Instructions
Separate plasma (preferred) or serum (acceptable) from whole blood within 24 hours of collection by centrifugation at 800-1600 X G for 20 minutes at room temperature. Transfer the plasma to a properly identified, sterile, polypropylene transport tube and ship refrigerated or frozen.
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 tubes • Heparinized samples
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-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
A.M.
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 |
