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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

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.

Performance

Parameters Performances
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 (400ul) 7.6 IU/Ml (200 ul)
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 in EDTA Plasma 100.0% (one-sided 95% confidence interval; 99.5%)
Genotypes detected HBV genotypes A-H, 61896A precore mutant
Parameters Performances
Sample type EDTA plasma, serum
Minimum amount of sample required 200 µL and 500 µL
Analytical sensitivity 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.

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.

Learn more about Roche's commitment to fighting viral hepatitis.

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.