cobas® HBV for use on the cobas® 4800 System

Better information for patient management

cobas® HBV, test for use on the cobas® 4800 System 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.

cobas® HBV offers:

  • 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

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.1

Intended Use
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.

Reference

  1. Hunt CM, McGill JM, Allen MI, Condreay LD. Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-1044.