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Improved Viral Load Testing for Hepatitis B Virus


Improve patient management and treatment success

In our continuous effort to improve our products and associated workflows, Roche Diagnostics is pleased to announce the availability of the new, enhanced Version 2.0 of the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test from April 2009. This highly sensitive test offers Roche’s fully automated real-time PCR technology to achieve a broad dynamic range for the quantitative detection of hepatitis B virus (HBV) DNA in patient plasma and serum.

According to the World Health Organization, approximately 2 billion people worldwide and about 350 million live with chronic HBV infection and are at risk of developing end stage liver disease and liver cancer. Even with a Hepatitis B vaccine, which has been available since 1982, about 600,000 people a year die worldwide from chronic active hepatitis, cirrhosis or primary liver cancer. Monitoring the levels of circulating hepatitis B virus is crucial as an indicator as to when hepatitis B therapies should be started, and to determine response to treatment. This test enables doctors to optimise patient treatment with standardized viral load measurements and enables laboratories to test efficiently with improved automation. Hepatitis B viral load testing enables clinicians to quantify the amount of hepatitis B virus in a patient’s blood, select patients for treatment, predict and assess individual responses to therapy and assess patients’ responses to therapy when they undergo treatment.

Better information for healthcare management

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test v2.0 (Cat. No. 04894570190) improves Hepatitis B virus load monitoring by

  • broad coverage of all known HBV genotypes (A-H) including pre-core mutations,
  • excellent performance and flexibility with serum and plasma specimens,
  • a broad dynamic range without grey zone from as low as 20 IU/mL and as high as 1.7×108 IU/mL,
  • standardisation against the WHO Standard for HBV with titre results reported in IU/mL.

In terms of test handling, a lowered sample input volume of 650 µL and increased on-board reagent stability of 56 days add to the improvements provided by the new test version.

See the Product Information flyer for more detailed performance data.


This test is designed for use on Roche’s automated platform combining the COBAS® AmpliPrep Instrument for automated sample preparation and the COBAS® TaqMan® Analyser or the smaller COBAS® TaqMan® 48 Analyser for automated real-time PCR amplification and detection. “Sample in/results out” testing eliminates manual intervention between steps and configuration options allow for customizable solutions for throughput needs. For a flexible throughput solution, the test offers up to 72 tests per kit in self sealing, ready-to-use reagent cassettes. The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 utilizes well established TaqMan® chemistry (over 2,000,000 HBV tests/year) and Roche’s proprietary AmpErase® enzyme designed to prevent cross-contamination of samples and labs is also included. Roche primers and probes target the highly conserved pre-core and core regions of the HBV genome, not the reverse transcriptase gene. The amplified region of the genome does not contain any portion of the S or P genes and will not be affected by mutations that arise due to drug resistance.

Correlation studies proved robust concordance with the current test version, thus the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test v2.0 is fully backward compatible and there is no need for re-validation or re-baselining. All that is needed to be done by current test users is to install the new Test Definition Files (Cat. No. 05385032190 for COBAS® TaqMan® 48 Analyser; Cat. No. 05385059190 for COBAS® TaqMan® Analyser) into AMPLILINK software.