COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test, v2.0

Sensitive detection for effective patient management

Detection of HCV RNA using a qualitative test confirms HCV antibody-positive specimens and provides evidence of an active infection. This highly sensitive test accurately detects HCV genotypes 1 through 6 with fully automated sample extraction and real-time PCR amplification and detection.

Features and Benefits

Benefits

  • Highly sensitive detection of HCV RNA combined with accuracy and specificity provides confidence in confirmatory HCV testing
  • Minimizes sample dilution
  • Ensures accurate detection and quantification of HCV genotypes 1 through 6
  • Assay performance is maintained with HCV isolates presenting sequence heterogeneity
  • Allows flexibility for the laboratory to manage patient samples more efficiently
  • Optimized and fully automated workflow maximizes laboratory efficiency

Features

  • Low limit of detection (LoD) = 15 IU/mL
  • Broad dynamic range of 15 – 1×108 IU/mL
  • Novel Dual Probe technology addresses global HCV sequence diversity with enhanced primer/probe sequence mismatch tolerance
  • Low sample input volume of 650 µL
  • Flexible batch size with continuous loading feature and interleave capability with core virology COBAS® AmpliPrep/COBAS® TaqMan® assays (HIV-1, HBV, and HCV Quant)

Intended Use

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.