Automated Assay Quantitatively Detects Hepatitis B Virus DNA

A test has been approved that provides a fully automated solution for the quantitative detection of Hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy.

The new assay uses a reduced sample input volume of 650 μL of either serum or plasma specimens and is standardized against the international standard for hepatitis B (World Health Organization [WHO]; Geneva, Switzerland).

The COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0 has been validated to quantify diverse samples from genotypes A-H and pre-core mutants across a broad linear dynamic range of 20 IU/mL to 1.7 ×10⁸ IU/mL. It has been approved by the U.S. Food and Drug Administration (FDA; Silver Springs, MD, USA) for use in that country.

This test is designed for and made by Roche Molecular Diagnostics (Pleasanton, California, USA), to use on their fully automated COBAS AmpliPrep/COBAS TaqMan System that is used in more than 250 clinical laboratories across the US. The platform combines the COBAS AmpliPrep Instrument for automated sample preparation and the COBAS TaqMan Analyzer or the smaller COBAS TaqMan 48 Analyzer for automated real-time PCR amplification and detection. Sample in and 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 72 tests per kit in self-sealing, ready-to-use reagent cassettes. Roche's proprietary AmpErase enzymes are also included in each test and are designed to prevent cross-contamination of samples.

Teresa Wright, M.D., Chief Medical Officer of Roche Molecular Diagnostics, said, "Viral load testing remains the gold-standard for the management of HBV antiviral therapy. Roche's new HBV test provides accurate and reproducible results at the key medical decision points, allowing the clinician to optimize patient outcomes." Approximately 4,500 cases of acute hepatitis B in the United States are reported each year and an estimated 43,000 persons are newly infected with HBV annually. However, because many HBV infections are either asymptomatic or never reported, the actual number of new infections is estimated to be approximately tenfold higher.

Related Links:
Roche Molecular Diagnostics
WHO
FDA