Hepatitis C Virus (HCV) RNA qualitative assay - blood plasma specimen
- LIS Mnemonic: HCVMA
Collect
PLASMA is the preferred specimen and Plasma Preparation Tubes (PPT with K2EDTA) are the preferred collection tubes. Other collection tubes containing K2EDTA, sodium heparin, sodium citrate, or acid citrate dextrose are also acceptable.
REMARK: SERUM is an acceptable alternative specimen. For serum, blood specimens should be collected in gold top serum separator tubes (SST) with clot activator and gel.
Liver tissue specimens may also be submitted for testing. Tissue should be placed in viral transport medium and transported at 4°C. Please consult the laboratory if necessary.
Volume Required
4-6 ml; tube should be completely filled, if possible
Minimum Required
4-6 ml; tube should be completely filled, if possible
Transport
Unprocessed blood specimens should be refrigerated at 4°C (2-8°C) shortly after collection and during transport to the laboratory, and should not be held at room temperature for longer than necessary. Liver tissue should be immediately placed in viral transport medium and transported at 4°C (2-8°C).
Stability
Unprocessed whole blood is stable at room temperature (up to 25°C) for up to 24 hours after blood draw. Processed plasma or serum are stable at 4°C (2-8°C) for up to 48 hours.
Unacceptable conditions
Specimens collected in inappropriate blood draw tubes and specimens that are not transported correctly.
Days Performed
Daily
Reported
Same day
Reflex Testing
Hepatitis C antibody performed on initial requests for Hepatitis C RNA qualitative assay
CPT
87521 (Hepatitis C RNA),86803 (Hepatitis C Antibody)
Methodology
The Gen-Probe APTIMA HCV RNA Qualitative Assay uses transcription-mediated amplification (TMA) to replicate highly conserved regions of the 5'-untranslated region of the RNA genome.
Disease Information
Utility:
HCV RNA is a direct marker for viral replication and infectivity; HCV RNA PCR is recommended to detect HCV infection in seronegative individuals and to discriminate chronic from resolved acute infection in patients who are positive for HCV antibody. Quantitative measure of RNA provides useful information about prognosis, transmission and response to therapy.
Interpretation
If positive, results are reported as hepatitis C virus RNA detected.
Reference Values
Negative or no hepatitis C virus RNA detected
Remarks
The analytical limit of detection of the assay is 5.3 IU/ml at a 95% confidence interval and the reported specificity of the assay is 99.6%. HCV genotypes 1-6 are known to be reactive in the APTIMA HCV RNA Qualitative Assay.
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