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cobas® HBV Test

Confidence and precision at medically relevant decision points
cobas® HBV Test

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® 4800/5800/6800/8800 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.

A critical assessment tool for long term patient monitoring

Roche hepatitis assays deliver robust, clinically relevant performance with a broad linear range, high sensitivity and optimal results within a fully automated workflow.

Registration status

cobas® HBV for 4800/5800/6800/8800 Systems: CE-IVD 

cobas® HBV for 5800/6800/8800 Systems: US-IVD

Package inserts

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

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    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® 4800/5800/6800/8800 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%)

      EDTA Plasma                   Serum
      4.4 IU/mL (400 µL)          2.8 IU/mL (400 μL)
      7.6 IU/mL (200 µL)          5.5 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® 5800/6800/8800 Systems Performance

    • Sample type

      EDTA plasma, Serum

       

    • Sample processing volume

      500 μL or 200 μL

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

      EDTA Plasma                  Serum
      500 µL: 2.7 lU/mL          500 µL: 2.4 IU/mL
      200 μL: 15.5 lU/mL**      200 μL: 12.5 IU/mL**

    • Linear range

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

    • Specificity

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

    • Genotypes detected

      HBV genotypes A-H, and predominant precore mutant

    *Not available in the United States.

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

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