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

Optimize HCV patient management and treatment success

Confidently monitor treatment response to HCV therapies with a highly sensitive limit of quantitation. The test accurately quantitates HCV genotypes 1 through 6 with fully automated sample extraction and real-time PCR amplification and detection.

Features and Benefits


  • Suitable for the new era of HCV therapeutics with robust performance and high accuracy to provide confidence in viral load results at key medical decision points.
  • 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.


  • Low limit of detection (LoD) = Limit of Quantitation (LoQ) = 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 Qual)

Intended Use

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.