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Hepatitis C Viral RNA, Quantitative, Real-Time PCR with Reflex to Genotype LiPA
Test Code11348
Alias/See Also
LAB916
CPT Codes
87522
Includes
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
1.5 mL
Other Acceptable Specimens
Plasma collected in: PPT EDTA (white-top) tube • Serum
Instructions
Separate plasma from whole blood within 24 hours of collection by centrifugation at 800 to 1600 x g for 20 minutes at room temperature. Transfer to a transport tube and refrigerate.
Serum collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate.
Serum collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate.
Transport Container
Transport tube
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 • Unspun serum separator tube (SST) • Unspun red-top tube (no gel) • Received room temperature
Methodology
Real-Time Polymerase Chain Reaction
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
Mon-sat
Reference Range
HCV RNA, QN, Real-Time PCR | Not detected (IU/mL) |
HCV RNA, QN, Real-Time PCR | Not detected (Log IU/mL) |
Clinical Significance
Useful in monitoring response to therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 log IU/mL).
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |