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Test Name:
Hepatitis C Virus RNA, Qualitative, by RT-PCR
- SBMF No:
36124 - Performance Lab Name:
Flow Cytometry/Molecular Pathology - Test Mnemonic:
HCV QUAL - ABN:
Not required - CPT Code:
87521 - LOINC Code:
11259-9 - Also Known As:
HCV RNA by RT-PCR, Qual - Also See:
25106 Hepatitis C Virus RNA, Quantitative, by RT-PCR
36123 Hepatitis C Virus Genotyping, by RT-PCR
36127 Hepatitis C Virus RNA, Quantitative, by RT-PCR, with Genotyping if Indicated - Spec Type:
Plasma - Spec Container:
Two (2) Pearl white top (PPT; EDTA + gel barrier) tubes - Alt Spec Type:
Plasma or serum - Alt Spec Container:
Two (2) Lavender top (EDTA), gold top (SST), or red top (serum) tubes
NOTE: Use the above alternate tubes only if pearl white top tube not available - Pref Vol:
3.0 mL - Min Vol:
1.5 mL
NOTE: This volume does not permit repeat analysis - Fasting:
No - Spec Collect:
Routine venipuncture
Separate samples must be submitted when multiple tests are ordered - Spec Process:
Serum sample tubes, clot 30 minutes
Promptly centrifuge 15 minutes
Immediately transfer serum or plasma to separate plastic tube
Properly centrifuged gel barrier tube sample does not require transfer of serum to separate tube - Spec Store Transport:
Refrigerated - Spec Stability:
Unprocessed sample (on cells): 6 hours room temperature (20-30°C)
After separation from cells:
3 days (72 hours) refrigerated (2-8°C)
6 weeks deep-frozen (-70°C) - Spec Reject:
Serum or plasma not separated from cells within 6 hours of collection - Spec Remarks:
Samples collected in gel-barrier tubes (PPT and SST) should be submitted in original container
Separate serum or plasma from cells within 6 hours of collection
Separate samples must be submitted when multiple tests are ordered - Methodology:
Reverse Transcription-Polymerase Chain Reaction (RT-PCR) - Use:
Assess viral response to antiviral treatment in conjunction with clinical presentation and other laboratory markers
Quantitative test is generally preferred for monitoring treatment - Clinical Significance:
Hepatitis C Virus is considered to be the principle etiologic agent responsible for 90-95% of the cases of post-transfusion non-A and non-B hepatitis. HCV is a single-stranded, positive sense RNA virus with a genome of approximately 10,000 nucleotides coding for 3,000 amino acids. Hepatitis C infection is highly prevalent among patients receiving organ transplants, blood transfusions, or commercial clotting factors, as well as persons involved in intravenous drug abuse and those undergoing renal dialysis.At the present time, an immunological assay for the direct detection of HCV antigen is unavailable. Also, direct detection by viral culture methods is also not available. Therefore, there is no method currently available to provide a quantitative measure of HCV viremia. Detection and quantification of HCV viremia by Polymerase Chain Reaction (PCR) offers a way to measure active viremia. It is possible, using PCR, to detect HCV viremia prior to immunological seroconversion, and to detect fluctuation of viremia in antibody-positive chronic HCV patients undergoing therapy with interferon. - Reference Range:
No HCV RNA detected
The extracted RNA sample from the patient's whole blood sample has been analyzed by RT-PCR. Sensitivity of the method can detect HCV viral RNA at the level of 43 IU/mL or lower.
This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.
- Additional Test Info:
A negative result does not rule out the presence of HCV RNA concentrations below the limit of detection by the assay - Day Run:
Tue, Thu - Time Run:
10:00 am - Time Reported:
48 hours - Test Type:
INFECTIOUS ANTIBODY