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cobas® HBV Test

cobas® HBV Test

Confidence and precision at medically relevant decision points

Delivering on clinical need requirements

 

Hepatitis B virus (HBV) DNA detection and viral load measurement are essential for treatment decisions and patient monitoring.1 cobas® HBV for use on the cobas® 4800/6800/8800 Systems provides security in your results with primers and probes targeting the highly conserved pre-core and core regions of the HBV genome. The amplified region of the genome will not be affected by mutations that arise due to drug resistance.2

cobas® HBV provides robust, clinically relevant assay performance with a broad linear range and high sensitivity, delivering optimal results throughout critical medical decision points and across all genotypes combined with a highly efficient laboratory workflow.1,3

Roche has been at the forefront of viral load monitoring tests for hepatitis and continues to provide a robust assay design to ensure accurate and reliable results to improve patient management and treatment success.

Features

  • Excellent performance with serum and plasma specimens
  • Built-in contamination control with AmpErase enzyme to prevent carryover contamination
  • Excellent correlation to Roche COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0
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Intended use

Intended use

CE-IVD

cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus DNA in human EDTA plasma or serum of HBV-infected individuals.

 

This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.

US-IVD

cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus DNA in human EDTA plasma or serum of HBV-infected individuals.

 

This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.

 

The cobas® HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.

Registration status

cobas® HBV for 4800 System: CE-IVD 
cobas® HBV for 6800/8800 Systems: CE-IVD; US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

 

  1. Janssen HLA. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167-85.
  2. Hunt CM, et al. Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-44.
  3. cobas® HBV Test for use on the cobas® 4800/6800/8800 System Package Inserts.

cobas® 4800 System* Performance

  • Sample type

    EDTA plasma, Serum

  • Sample processing volume

    400 µL or 200 µL

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

    4.4 IU/mL (400 µL) 
    7.6 IU/mL (200 µL)

  • Linear range

    400 µL: 10 lU/mL - 1.0 x 109 IU/mL
    200 µL: 10 lU/mL - 1.0 x 109 IU/mL

  • Specificity

    100.0% (one-sided 95% confidence interval; 99.5%)

  • Genotypes detected

    HBV genotypes A-H, 61896A precore mutant

cobas® 6800/8800 Systems** Performance

  • Sample type

    EDTA plasma, Serum

     

  • Minimum amount of sample required

    200 µL and 500 µL

  • Analytical sensitivity in EDTA plasma

    200 µL: 15.5 lU/mL 
    500 µL: 6.6 lU/mL

  • Linear range

    200 µL: 25 lU/mL - 1.0 x 109 IU/mL
    500 µL: 10 lU/mL - 1.0 x 109 IU/mL

  • Performance with HBV DNA-negative samples

    100.0% "Target Not Detected" (with a two-sided 95% confidence interval of 99.4% - 100%)

  • Genotypes detected

    HBV genotypes A-H, and predominant precore mutant

*Not available in the United States.

**US-IVD data only.

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