COBAS® TaqMan® HCV Test v2.0 For Use With The High Pure System

Hepatitis C virus (HCV) viral load testing quantification

An in vitro nucleic acid amplification test for the quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma.

The High Pure System Viral Nucleic Acid Kit allows manual specimen preparation and the COBAS® TaqMan® 48 Analyzer automates amplification and detection. This test utilizes real time PCR technology for the detection and quantitation of HCV RNA.

Features and Benefits

Features

  • CE-IVD: Sensitivity (LOD; genotype 1) – plasma: 9.3 HCV RNA IU/mL, serum: 8.8 HCV RNA IU/mL; linear range – 25 to 3.91×10^8 IU/mL
  • FDA-IVD: Sensitivity (LoD; across all genotypes) – 20 IU/mL; Linear range –Quantitation of HCV RNA from 25 to 3×10^8 IU/mL
  • COBAS® TaqMan® 48 Analyzer for automated real-time PCR amplification and detection

Benefits

  • Minimizes testing errors and manual intervention steps with automated closed-tube amplification and detection on the COBAS® TaqMan® 48 Analyzer
  • Improves result integrity with bar coded samples for sample tracking – AmpErase enzyme reduces risk of contamination – internal quantitation standard eliminates need for calibration

Intended Use

(CE-IVD)
The COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System (HPS) is an in vitro nucleic acid amplification test for the quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and 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 as an aid in assessing viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels. Recent data suggest that early changes in serum/plasma HCV RNA levels may predict long-term response to interferon therapy.1

The 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 or as a diagnostic test to confirm the presence of HCV infection.

(FDA-IVD)
The COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System is an in vitro nucleic acid amplification test for the quantitation of hepatitis C virus (HCV) RNA in human plasma or serum of HCV-infected individuals using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 through 6 have been validated for quantitation in the assay.

The COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System 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 used to predict sustained and non-sustained virological response to HCV therapy. The results from the COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System 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® TaqMan® HCV Test, v2.0 For Use With The High Pure System 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.

References

  1. Orito, E., Mizokami, M., Suzuki, K. et al. Loss of serum HCV RNA at week 4 of interferon-a therapy is associated with more favorable long-term response in patients with chronic Hepatitis C. Journal of Medical Virology. 1995;46:109-115.