COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
US-IVD
Improve patient management and treatment success
Fully automated hepatitis B virus (HBV) viral load quantitation for improved testing in serum and plasma
An in vitro nucleic acid amplification test for the quantitation of HBV DNA in human plasma and serum.
  • Measures HBV DNA levels at baseline and during treatment to aid in assessing response to treatment
  • Detects genotypes A-H and pre-core mutants.
  • Offers a broader dynamic range than previous generation tests – from 20 to 1.7E+08 IU/mL
  • Offers both serum and plasma specimen type
  • Uses a 650 μl sample processing volume
Features and Benefits
 
Features
  • Highly sensitive and accurate
  • Optimizes patient treatment
  • Efficient automated testing and standardized viral load measurements
  • A fully automated, docked platform that uses the COBAS® AmpliPrep Instrument to automate specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer to automate amplification and detection.
Benefits
  • Improves the ability to monitor patients throughout critical medical decision points
  • Offers use of serum or plasma specimen – requires half the sample input volume of previously available tests
  • Covers known HBV genotypes including pre-core mutants
  • Provides robust correlation to the previous version of the test
  • Is standardized against WHO standards for HBV, and titer results are reported in IU/mL
  • Can be run in combination with HIV and HCV on the same platform
Intended Use
 
The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human serum or plasma (EDTA), using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection.
 
This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing antiviral 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 the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 must be interpreted within the context of all relevant clinical and laboratory findings.
 
Assay performance characteristics have been established for individuals treated with adefovir dipivoxil. Assay performance for determining the state of HBV infection has not been established.
 
The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 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.
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.
 
 
Contact

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