COBAS® AmpliPrep/COBAS® AMPLICOR HCV Test, v2.0 

 
Registration Status

Canada-IVD
CE-IVD
US-IVD
Hepatitis C Virus (HCV) detection
An in vitro diagnostic nucleic acid amplification test for the qualitative detection of HCV RNA in human serum or EDTA-plasma.
 
This test is run on the COBAS® AMPLICOR Analyzer, which automates PCR amplification and detection of HCV RNA.
 
This test is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected of being actively infected with HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active HCV infection.
Features and Benefits
 
Features
  • Qualitative nucleic acid-based hepatitis C test approved by the FDA
Benefits
  • Detects HCV RNA levels as low as 50 IU/mL in plasma and as low as 60 IU/mL in serum (with equivocal results excluded)
  • Sensitivity, reliability, and rapid detection of active HCV infections in patients
Intended Use
 
The COBAS® AMPLICOR® Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) is a qualitative in vitro test for the detection of Hepatitis C Virus RNA in clinical specimens on the COBAS® AMPLICOR® Analyzer. The presence of HCV RNA is evidence of current HCV infection in patients presenting with clinical and/or biochemical evidence of liver disease. The test utilizes reverse transcription of target RNA to generate complementary DNA (cDNA), amplification of target cDNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of HCV RNA in human serum or plasma.
 
The COBAS® AMPLICOR® HCV Test, v2.0 is not intended for use in screening blood or blood products for the presence of Hepatitis C Virus.
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
Contact

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