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Hepatitus C RNA PCR, Quantitative
Test CodeLab1753
Alias/See Also
HCVPCR
CPT Codes
87522
Preferred Specimen
BD Vacutainer Plasma Preparation Tubes (PPT)
Minimum Volume
3 mL
Other Acceptable Specimens
Serum Separation Tubes (SST)
BD Vacutainer EDTA tubes
BD Vacutainer EDTA tubes
Instructions
If collecting specimen in SST, centrifuge SST after clotting to separate serum from cells.
Transport Container
BD Vacutainer Plasma Preparation Tubes (PPT)
Serum Separation Tubes (SST)
BD Vacutainer EDTA tubes
Serum Separation Tubes (SST)
BD Vacutainer EDTA tubes
Transport Temperature
Ambient
Refrigerated if specimen centrifuged prior to transport
Refrigerated if specimen centrifuged prior to transport
Specimen Stability
Prior to plasma/serum preparation:
Up to 24 hours ambient or refrigerated
After plasma/serum separation:
Up to 6 days refrigerated
Up to 12 weeks frozen at ≤ -18°C.
For long-term storage up to 6 months, temperatures at ≤ -60°C are recommended.
Up to 24 hours ambient or refrigerated
After plasma/serum separation:
Up to 6 days refrigerated
Up to 12 weeks frozen at ≤ -18°C.
For long-term storage up to 6 months, temperatures at ≤ -60°C are recommended.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Storage and stability requirements not met
Improper or no label on container
Improper container
Leaking container
Quantity not sufficient
Expired collection tube
Improper or no label on container
Improper container
Leaking container
Quantity not sufficient
Expired collection tube
Methodology
Cobas® HCV PCR
Setup Schedule
Tuesday and Friday
Reference Range
HCV RNA Quant PCR IU/mL <15
HCV RNA Quant PCR logIU/mL <1.18
HCV RNA Quant Interpretation Not detected
HCV RNA Quant PCR logIU/mL <1.18
HCV RNA Quant Interpretation Not detected
Clinical Significance
Cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of HCV RNA in HCV-antibody positive or HCV-infected individuals.
The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
The test is also intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings.
The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
The test is also intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings.
Performing Laboratory
Meritus Molecular Diagnostics - Microbiology
