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cobas® HBV for use on the cobas® 4800 System

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 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.

Performance

Parameter 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
5 IU/mL (400 µL);
10 IU/mL (200 µL)
Linear range 400 µL: 10 IU/mL – 1 x 109 IU/mL
200 µL: 10 IU/mL – 1 x 109 IU/mL
Specificity in EDTA Plasma 100.0% (one-sided 95% confidence interval; 99.5%)
Genotypes detected HBV genotypes A-H, precore mutant

A critical assessment tool for long term patient monitoring

Discover robust, clinically relevant assay performance with a broad linear range, high sensitivity and optimal results within a fully automated workflow. Learn more about cobas® HBV for the cobas® 4800 System.

References:

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