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Hepatitis C Viral RNA, Quantitative, Real-Time PCR with Reflex to Genotype LiPA : 11348
Test CodeHCVQNR or 11348
CPT Codes
87522
Includes
If the viral load is greater than or equal to 300 IU/mL, Hepatitis C Viral RNA, Genotype, LiPA (test code HCVGT) will be performed at an additional charge (CPT code(s): 87902). (If reflex: 37811, HCVGT)
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 from cells within 24 hours of collection by centrifugation. Follow manufacturer’s instructions for collection tube handling.
Primary tubes or aliquots from primary tubes preferred; specimen sharing is not recommended.
Primary tubes or aliquots from primary tubes preferred; specimen sharing is not recommended.
Transport Container
Preferred Specimen:
3 mL plasma collected and separated from an EDTA (lavender-top) tube
Alternative Specimens:
Plasma collected in PPT potassium EDTA (white-top) tube; Serum
Minimum Volume: 1.5 mL
3 mL plasma collected and separated from an EDTA (lavender-top) tube
Alternative Specimens:
Plasma collected in PPT potassium EDTA (white-top) tube; Serum
Minimum Volume: 1.5 mL
Transport Temperature
Frozen.
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 >72 hours
Methodology
Real-Time Polymerase Chain Reaction
If reflex, Reverse Transcriptase Polymerase Chain Reaction
Setup Schedule
Monday & Wednesday & Friday
Reflex test: Sunday - Saturday
Reflex test: Sunday - Saturday
Report Available
1-4 days; if reflexed: reflex test will report separately in 2-5 days after receipt at performing laboratory
Limitations
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.
Reference Range
Reportable Range: 15 to 100,000,000 IU/mL or 1.18 to 8.00 log IU/mL
Reference range:
Not Detected IU/mL
Not Detected log IU/mL
Reflex: By report
Reference range:
Not Detected IU/mL
Not Detected log IU/mL
Reflex: By report
Clinical Significance
Useful in monitoring therapy and/or disease progression.
Performing Laboratory
med fusion and Quest Diagnostics