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cobas® HCV Test

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Innovative, dual-probe HCV viral load testing for the cobas® 4800 and cobas® 5800/6800/8800 Systems

Accurate quantification and detection for an ever-changing virus

 

Every day, approximately 4,000 people die from the consequences of viral hepatitis, and 1.4 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 ® 4800 and cobas ® 5800/6800/8800 Systems, offers precise, dual-probe HCV viral load testing to accurately identify the 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
  • Excellent correlation with the COBAS® AmpliPrep / COBAS® TaqMan® HCV Quantitative Test, v2.0

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 optimised clinical decision
Intended use

Intended use

cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV-infected individuals. Samples containing HCV genotype 1 to 6 are validated for detection and quantitation in the assay. 

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 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. 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 must be interpreted within the context of all relevant clinical and laboratory finding.  

 

These are the intended use for the cobas HBV assay on the different platforms

 

cobas® HCV 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.   

cobas® HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV 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 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 to antiviral treatment (response guided therapy) as measured by changes of HCV RNA levels in serum or EDTA plasma. The results must be interpreted within the context of all relevant clinical and laboratory findings.   

Registration status

cobas® HCV for 4800 System: CE-IVD 

cobas® HCV for 5800/6800/8800 Systems: CE-IVD

 

Package inserts

Access package inserts through your Roche DiaLog.

 

Related diseases

Reference

 

  1. World Health Organization (WHO). World Hepatitis Day.
     http://www.who.int/campaigns/hepatitis-day/2016/event/en. Accessed July 2016. 
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Related information

cobas® 4800 System Performance

  • Sample type

    EDTA plasma, serum

  • Sample processing volume

    400 µL or 200 µL

  • Analytical sensitivity

    9.2 lU/mL (400 µL)
    15.3 lU/mL (200 µL)

  • Linear range

    400 µL: 15 lU/mL - 1.0E+08 IU/mL
    200 µL: 25 lU/mL - 1.0E+08 IU/mL

  • Specificity

    99.5% (one-sided 95% confidence interval: 98.7%)

  • Genotypes detected

    HCV genotypes 1-6

cobas® 5800/6800/8800 Systems Performance

  • Sample type

    EDTA plasma, serum

  • Minimum amount of sample required

    650µL or 350µL

  • Sample processing volume

    500µL or 200µL

  • Analytical sensitivity

    15 lU/mL (500 µL)
    40 lU/mL (200 µL)

     

  • Linear range

    500 µL: 15 lU/mL - 1.0E+08 IU/mL
    200 µL: 40 lU/mL - 1.0E+08 IU/mL

  • Specificity

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

  • Genotypes detected

    HCV genotypes 1-6

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