COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative and Quantitative Tests, v2.0 

 
Registration Status

CE-IVD
Empowering Change in HCV
Effectively detect active HCV infection and monitor treatment response with one fully automated workflow system
Confirm active infection and monitor treatment response to HCV therapies with a highly sensitive limit of detection and quantitation. The tests* accurately detect and quantitate HCV genotypes 1 through 6 with fully automated sample extraction and real-time PCR amplification and detection.
Benefits
  • State of the art assays with robust performance
  • Superior workflow to maximize laboratory efficiency
  • Medically relevant tests for the new ear of HCV therapeutics
Features
  • Low limit of detection at 15 IU/mL suitable for the new era of HCV therapeutics
  • Broad dynamic range of 15 – 1E108 IU/mL minimizes sample dilution
  • Novel probe technology enhances primer/probe sequence mismatch tolerance for accurate detection and quantitation of HCV genotypes 1 through 6
  • High specificity and excellent precision prevent false positive results and ensure precision at key medical decision points
  • Low sample input volume of 650uL allows flexibility for the laboratory
  • Flexible batch size with continuous loading feature and interleave capability with core virology COBAS® TaqMan® assays (HIV-1, HBV, HCV Quant and HCV Qual) 
Intended Use
 
(Qualitative)
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test, v2.0 is a qualitative in vitro nucleic acid amplification test for the detection of Hepatitis C Virus (HCV) RNA genotypes 1 to 6 in human EDTA plasma or serum using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test, v2.0 is indicated for patients who have clinical and/or biochemical evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
 
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test, v2.0 is not intended for use as a screening test for the presence of HCV in blood or blood products.

(Quantitative )
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA genotypes 1 to 6 in human EDTA plasma or serum using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test is intended for use in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy, and to assess viral response (response guided therapy) to antiviral treatment as measured by changes of HCV RNA levels in serum or EDTA plasma.
 
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0 is not intended for use as a screening test for the presence of HCV in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.
*Not available in the United States
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.
 
 
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