COBAS® TaqMan® HBV Test For Use With The High Pure System 

 
Registration Status

Canada-IVD
CE-IVD
US-IVD
Improving patient management and treatment success
Hepatitis B virus (HBV) viral load quantification test used in the management of patients with chronic HBV undergoing antiviral therapy
The test provides clinically relevant assay performance, and high sensitivity to deliver optimal results throughout critical medical decision points and across all genotypes.
 
The High Pure System Viral Nucleic Acid Kit allows for manual specimen preparation and the COBAS® TaqMan® Analyzer for automated amplification and detection.
Features and Benefits
  • Highly sensitive and accurate detection of all known genotypes and precore mutant
  • Broad dynamic range from 29-1.1x107 IU/mL
  • Robust correlation to automated version COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0
  • Minimizes testing errors with closed-tube amplification and detection on the COBAS® TaqMan® 48 Analyzer
  • Improves result integrity, with inbuilt AmpErase enzyme reduces the risk of carryover contamination
Intended Use
 
The COBAS® TaqMan® HBV Test For Use With The High Pure System (HPS) is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma, using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.
 
The COBAS® TaqMan® HBV Test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.
 
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
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