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

Better information for patient management

The cobas® HBV test for use on the cobas® 6800/8800 Systems 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.

Highly optimized primer-probe selection

  • HBV DNA detection and viral load measurement are essential for the diagnosis, decision to treat and subsequent monitoring of patients.1
  • Roche primers and probes target 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

Features and Benefits 

  • Broad coverage of all known HBV genotypes (A-H) including pre-core mutations
  • Tight precision at medically relevant decision points
  • 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.

cobas® 6800/8800 Systems are not available in all markets, including the U.S.

Learn more at www.cobas68008800.com/assay_menu

References

  1. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. Journal of hepatology. 2012:57(1).
  2. Hunt, C.M., et al., Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-44.