Abbott Receives CE Mark for New Hepatitis Test

11-11-2011: Abbott announced it has received CE Marking (Conformité Européenne) in the European Union to market a new, highly sensitive diagnostic test for detection of hepatitis B surface antigen (HBsAg). The test is performed on Abbott's ARCHITECT® system.

HBsAg assays may be used to help identify acute and chronic HBV infections, to screen blood and blood products, and to aid in the diagnosis of infected pregnant women. Perinatal HBV transmission can frequently be prevented by immunizing the infant at birth.

"The hepatitis B virus is constantly evolving, and it is important to have a test that has the right sensitivity to detect different strains of the virus," said Dr. Thoai Duong Ly, biologist, Biomnis. "The new ARCHITECT hepatitis B surface antigen test is an important tool in helping to detect mutant strains of the virus."

The ARCHITECT HBsAg Qualitative II assay is intended to be used as an aid in the diagnosis of HBV infection and as a screening test for donated blood and plasma using the ARCHITECT immunochemistry system. It provides qualitative detection of HBsAg, which is the first serological marker after infection with HBV and appears in the blood between one to 10 weeks after exposure to the virus.

"Our research and assay development in hepatitis demonstrates the role advanced diagnostics technology is playing to enable clinicians to detect infectious diseases rapidly and accurately," said Brian Blaser, senior vice president, Diagnostics, Abbott. "Introduction of the new ARCHITECT hepatitis B surface antigen assay is another milestone in Abbott's 40-year history of achievement in hepatitis diagnostics."