Hepatitis C Viral RNA, Quantitative, Real-Time PCR with Reflex to Genotype LiPA

Test Code
11348


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 potassium 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.


Transport Container
Transport tube


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 72 hours
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
Set up: Mon-Sat; Report available: 2-4 days


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).




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.