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cobas® HCV

Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> HCV

Accurate quantification and detection for an ever-changing virus

Every day, approximately 3,000 people die from the consequences of viral hepatitis, and 1.1 million people every year1 Roche is committed to fighting viral hepatitis with effective diagnosis and monitoring. For hepatitis C, cobas® HCV for use on the cobas® 5800/6800/8800 System, offers precise, dual-probe HCV viral load testing to accurately identify disease and determine patient response to treatment.

See what truly matters when testing for HCV

A quantitative hepatitis C virus (HCV) RNA test must be able to tolerate sequence mismatches for accurate and reliable results. The combination of error-prone RNA replication and a high rate of virus production results in extreme genetic variability of HCV. Clinicians rely on regular HCV viral load assessment to achieve an optimal treatment outcome.

The cobas® HCV quantitative nucleic acid test delivers robust, clinically relevant assay performance based on the proprietary dual-probe assay design from Roche. cobas® HCV is designed to deliver high sensitivity to meet the requirements of current and future chronic hepatitis C therapies combined with an efficient workflow for laboratories.

The innovative, state-of-the-art dual-probe HCV viral load assay precisely distinguishes true signals from background noise leading to more accurate quantification of viral loads.

Features

  • Accurate detection and quantification of HCV genotypes 1 through 6
  • Clinically validated for use with new HCV therapies
  • Optimised clinical decisions through precise HCV viral load assessment
  • Accurate HCV RNA viral load results are important for monitoring patients treated with the DAAs to decide on continuation of therapy and assess treatment success
  • The Roche HCV dual-probe assay helps clinicians to better manage HCV patients facilitating optimized clinical decision

cobas® 5800/6800/8800 Systems Performance2

  • Sample type

    EDTA plasma, serum

  • Minimum amount of sample required

    650 µL

  • Sample processing volume

    500 µL or 200 µL

  • Analytical sensitivity (LoD by hit rate of ≥95%)

    500 μL: 15 IU/mL   200 μL: 40 IU/mL **

  • Linear range

    500 μL: 15 IU/mL – 1x108 IU/mL  200 μL: 40 IU/mL – 1x108 IU/mL **

  • Specificity

    100% (one-sided 95% confidence interval: 99.5%)

  • Genotypes detected

    HCV genotypes 1-6

*Not available in the United States.

**200 μL volume not commercially available in the United States.

References

  1. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. https://www.who.int/publications/i/item/9789240027077. Accessed September 2022.
  2. cobas® HCV for use on the cobas® 5800/6800/8800 Systems Instructions for Use, Document Version 3.0, 26-09-2022, Pleasanton, CA; Roche Molecular Systems.

Overview

Detailed Specifications

Ordering Information

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