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HEPATITIS C (HCV) QUANT by PCR
Test CodeLAB8018
Alias/See Also
Hep C viral load
CPT Codes
87522
Includes
- HCV by PCR Interpretation
- HCV (IU/mL)
- HVC (log IU/mL)
- HVC Test Comment
Preferred Specimen
1 Gold tube (SST)
Patient Preparation
None
Minimum Volume
2 mL (3 mL optimal)
Other Acceptable Specimens
1 Lavender tube (EDTA)
Note: Heparin tubes are not acceptable
Note: Heparin tubes are not acceptable
Instructions
Centrifuge for complete separation of serum from red cells.
Transport Container
Refrigerate
Transport Temperature
Gold tube
Specimen Stability
2-8°C up to 3 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
- Heparinized plasma
- Quantity Not Sufficient (QNS)
Methodology
Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Setup Schedule
M, T, W, Th, F
Report Available
Final report available within 1-4 days after specimen received in the lab.
Reference Range
Not Detected
A qualitative interpretation of either DETECTED or NOT DETECTED is provided. When HCV is detected, a quantitative result of IU/mL and log (IU/mL) is also provided. The limit of quantitation for this assay is 12-100,000,000 IU/mL or 1.08-8.00 log (IU/mL).
The Alinity m HCV assay is designed to target a highly conserved sequence of the HCV genome. The HCV primers and probes for the assay include a second probe to further ensure assay robustness against new and emerging HCV variants. The design ensures accurate detection and quantitation of HCV genotypes 1 through 6 while maintaining high sensitivity.
A qualitative interpretation of either DETECTED or NOT DETECTED is provided. When HCV is detected, a quantitative result of IU/mL and log (IU/mL) is also provided. The limit of quantitation for this assay is 12-100,000,000 IU/mL or 1.08-8.00 log (IU/mL).
The Alinity m HCV assay is designed to target a highly conserved sequence of the HCV genome. The HCV primers and probes for the assay include a second probe to further ensure assay robustness against new and emerging HCV variants. The design ensures accurate detection and quantitation of HCV genotypes 1 through 6 while maintaining high sensitivity.
Clinical Significance
Intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV
infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.
This assay is not intended to be used in screening blood, plasma, serum, tissue, or tissue donors for HCV.
infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.
This assay is not intended to be used in screening blood, plasma, serum, tissue, or tissue donors for HCV.
