Hepatitis C Viral RNA, Quantitative, Real-Time PCR

Test Code
35645


Alias/See Also
LAB00365


CPT Codes
87522

Preferred Specimen
3 mL plasma collected and separated from an EDTA (lavender-top) tube


Minimum Volume
1 mL


Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum


Instructions
Do not freeze whole blood or any samples stored in primary tube. 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.


Transport Container
Transport tube


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 84 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Whole blood samples >24 hours old • Frozen whole blood


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 Log IU/mL
HCV RNA, QN, Real-Time PCR Not detected IU/mL


Clinical Significance
Useful in monitoring 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




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.