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

Optimize HCV patient management and treatment success

Delivering on clinical need requirements

These tests offers the ability to qualitatively detect hepatitis C virus or quantitatively determine amounts of HCV circulating in a patient’s blood. The test incorporates Roche’s novel dual-probe technology to address the global HCV sequence diversity with enhanced primer/probe sequence mismatch tolerance.

The diagnosis of acute and chronic HCV infection is based on the detection of HCV RNA by a sensitive molecular method (lower limit of detection greater than or equal to 15 international units IU/ml).1 The 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.

You can confidently monitor viral load results with the quantitative test at key medical decision points for optimized HCV treatment.

Features

  • Flexible batch size with continuous loading feature and interleave capability with core virology COBAS® AmpliPrep/COBAS® TaqMan® assays (HIV-1, HBV, CMV and HCV Qual)
  • Precisely distinguish true signals from background noise for more accurate viral load results

Performance

Parameters Performances
Sample type EDTA plasma, serum
Sample processing volume 500 µL
Analytical sensitivity
(LoD by hit rate of ≥ 95% ) in EDTA Plasma
15 IU/mL
Linear range 15 – 1.7 x 106 IU/mL
Specificity  100% (one-sided lower 95% confidence limit: >99.5%)
Genotypes detected HCV genotypes 1-6

Intended use

CE-IVD

  • 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.

US-IVD

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C (HCV) RNA genotypes 1 to 6 in human EDTA plasma or serum of HCV-infected individuals 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 as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

The test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy in conjunction with clinical and laboratory markers of infection. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings.

Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus ribavirin. No information is available on the assay’s predictive value when other therapies are used.

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 is not intended for use as a screening test for the presence of HCV in blood or blood products.

HCV detection for optimal patient management

Effective management of HCV patients relies on accurate diagnosis. Optimize both diagnosis and treatment management for HCV infected patients with the COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative and Quantitative Tests, v2.0.

Reference:

  1. Journal of Hepatology. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. http://www.easl.eu/medias/cpg/HCV2016/Summary.pdf. Accessed December 12, 2016.