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

Test Code

11348

CPT Codes
87522

Includes

If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥2000 IU/mL, then Hepatitis C Virus RNA Genotype 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. Transfer to a transport tube and refrigerate or freeze.
Serum is collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 30 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 • Gross hemolysis • Grossly lipemic • Specimens collected using heparin as anticoagulant

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

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.