COBAS® AmpliPrep/COBAS® TaqMan® HCV Test

Improve patient management and treatment success

Fully automated Hepatitis C Virus (HCV) quantification test

An in vitro nucleic acid amplification test for the quantitation of HCV RNA in human plasma or serum.

This test uses the COBAS® AmpliPrep Instrument to automate specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer to automate amplification and detection. The test utilizes real-time PCR technology in the quantitation of HCV RNA.

Features and Benefits

Features

  • Highly sensitive and accurate
  • A fully automated, docked platform that uses the COBAS® AmpliPrep Instrument to automate sample preparation and the COBAS® TaqMan® Analyzer to automate real-time PCR amplification and detection

Benefits

  • Quantification of HCV RNA, genotypes 1 through 6, with a linear range of 43 to 69,000,000 IU/mL
  • Complete automation means “sample in/results out,” eliminating manual intervention to improved workflow efficiency and test result integrity.
  • Multiple configuration options: use of an undocked station and/or COBAS® TaqMan® 48 – a lower capacity instrument – provide customizable workflow options for laboratories.
  • Bar coded reagents packaged in ready-to-use, spill-proof cassettes for ease-of-use and  self-sealing caps for increased stability
  • Bar coded samples for sample tracking and result integrity
  • AmpErase enzymes reduce the risk of contamination

Intended Use

(FDA-IVD)

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test is anin vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human 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. Specimens containing HCV genotypes 1 – 6 have been validated for quantitation in the assay.
The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test 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. Assay performance for determining the state of HCV infection has not been established.

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test 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.

(EU-IVD)

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test is anin vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human 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 conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV. The test can be used to assess the probability of a sustained viral response early in a course of antiviral therapy and to assess viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels. The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test 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.