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cobas® HBV for use on the cobas® 6800/8800 System

Better information for patient management

Delivering on clinical need requirements

HBV DNA detection and viral load measurement are essential for the treatment decision and subsequent monitoring of patients.1 cobas® HBV primers and probes provide security in your results by targeting the highly conserved pre-core and core regions of the HBV genome. Mutations that arise due to drug resistance will not affect the amplified region of the genome.2

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

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

  • Testing flexibility with two sample input volumes (200 µL and 500 µL) and clinically relevant sensitivity
  • 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 (HBV) 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 (HBV) 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
Minimum amount of sample required 200 µL and 500 µL
Analytical sensitivity EDTA plasma
200µL: 15.5 IU/mL
500µL: 6.6 IU/mL
Linear range 200µL: 25 IU/mL – 1 x 109 IU/mL
500µL: 10 IU/mL – 1 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
*US-IVD data only

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® 6800/8800 Systems.

References:

  1. Janssen HLA. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J hepatol. 2012;57(1):167-85.
  1. Hunt CM, McGill JM, Allen MI, Condreal LD. Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-44.