Abbott and Celera, an Applera Corporation business, announced that Abbott has received CE marking for a real-time PCR (polymerase chain reaction) test for monitoring hepatitis B (HBV) viral load in patients, allowing the test to be marketed in the European Union. Abbott is marketing the test under its strategic alliance with Celera.

The Abbott RealTime HBV test, developed for use on the Abbott m2000 automated instrument system, is designed for the quantitation (precise measurement) of HBV in human plasma or serum from patients known to be infected with the virus. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing a patient's response to antiviral treatment. With the addition of the HBV test, the m2000 offers the broadest menu of molecular tests available on a single instrument platform. The m2000 menu includes real-time PCR tests for HIV-1, hepatitis C, chlamydia, and a combination test for chlamydia and gonorrhea.

Quantitative measurements of HBV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of patients with HBV. An initial measurement of HBV viral load can guide a decision to begin antiviral therapy, while monitoring HBV DNA levels during therapy can influence its duration and also signal the development of drug resistance.

In addition, the higher the baseline viral level the more likely a patient is to develop hepatocellular carcinoma, a primary cancer of the liver.

"The Abbott RealTime HBV assay is the only test currently, available that targets an essential, highly conserved segment of the HBV genome, which makes it a very reliable test for detecting and measuring all known HBV genotypes," said John Robinson, PhD, senior director, research and development, Abbott Molecular. "It gives physicians one of the most precise tests available to guide treatment decisions and builds upon Abbott's 30-year legacy in hepatitis testing."

HBV genomes have been classified into eight genotypes (A-H). Detecting HBV genotypes is important in terms of both monitoring the disease and guiding treatment decisions.

The Abbott RealTime HBV assay has been developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to efficiently detect and measure life-threatening viruses and bacteria in patient serum or plasma samples in less than five hours, compared to other testing methods that may take up to two days. The RealTime HBV test is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.

Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera. In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.

"We're very pleased that the menu for the m2000 system is expanding in Europe with the registration of the RealTime assay for monitoring hepatitis B viral load," said Kathy Ordoñez, president, Celera. "The five tests now approved for sale in Europe on the m2000 system reinforce the system's breadth of menu as a competitive advantage."