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Test Name:
Hepatitis C Virus Genotyping, by RT-PCR
- SBMF No:
36123 - Performance Lab Name:
Flow Cytometry/Molecular Pathology - Test Mnemonic:
HCV GENO- - ABN:
Required – Not FDA-Approved - CPT Code:
87902 - LOINC Code:
32286-7 - Also Known As:
HCV Genotyping
VERSANT® HCV Genotype 2.0 Line Probe Assay (LiPA) - Also See:
25106 Hepatitis C Virus RNA, Quantitative, by RT-PCR
36124 Hepatitis C Virus RNA, Qualitative, 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), pale yellow top (ACD), gold top (SST), or red top (serum) tubes
NOTE: Use the above alternate tubes only if pearl white top tube not available - Min Vol:
3.0 mL - Fasting:
No - Patient Prep:
This test may be unsuccessful if the HCV viral load is less than 1,000 IU/mL of plasma or serum
Supply copy of prior viral load result if quantitative testing is not ordered at this time - 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)
4 months deep-frozen (-70°C) - Spec Reject:
Less than 1,000 IU/mL of Hepatitis C Virus in sample
Serum or plasma not separated from cells within 6 hours of collection - Spec Remarks:
Samples collected in gel-barrier tubes (PPT or 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 and Real-Time Polymerase Chain Reaction (RT-PCR) - Use:
Aid in the clinical management and prognosis of HCV infection - Clinical Significance:
HCV infection is a leading cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma, with more than 170 million people chronically infected worldwide. Very effective treatment is now available. The combination of pegylated interferon and ribavirin can eradicate the virus in more than 50% of patients. These antiviral treatments reduce liver fibrosis progression and can reverse cirrhosis.Knowledge of the genotype and viral load results help to predict sustained virological response and the choice of treatment duration. Response rates to treatment by pegylated interferon and ribavirin combination are about 88% for genotypes 2 and 3 and 48% for the other 4 genotypes. Genotypes do not change during the course of infection; however, co-infections are known to exist. - Reference Range:
By report
Interpretive Data:
Extracted HCV RNA is analyzed using reverse transcription polymerase chain reaction (RT-PCR). Both 5'UTR and core regions of the HCV virus are targeted for amplification to detect 6 major genotypes, genotypes 1 to 6 and the majority of common subtypes. Although determination of subtype may not be clinically important.Knowledge of the genotype is helpful for prediction of sustained virological response and the choice of treatment duration. Response rates to treatment are about 88% for genotypes 2 and 3 and 48% for the other 4 genotypes. The severity of the disease (fibrosis stage) is not related to the genotype.
This test uses analyte specific reagent (ASR). The method was developed and its performance characteristic determined by South Bend Medical Foundation Laboratory. It has not been cleared or approved by the U.S. FDA. This test is used for clinical purposes and should not be regarded as investigational or for research. SBMF is certified under CLIA as qualified to perform high complexity clinical laboratory testing.
This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.
- Day Run:
Wed - Time Run:
10:00 am - Time Reported:
48 hours - Test Type:
INFECTIOUS ORGANISM
