Bio-Rad Laboratories Inc announced that two of its test kits used for the screening and confirmation of the Hepatitis B virus have been approved by the United States FDA (Food and Drug Administration). Bio-Rad's Genetic Systems HBsAg EIA 3.0 and HBsAg Confirmatory Assay 3.0 also received Medical Device Licenses from the Medical Devices Bureau at Health Canada. These tests replace the company's existing Hepatitis B kits. They are more sensitive, easier to use, and they are the only Hepatitis B tests on the market approved for use on cadaveric samples, or samples taken from organ donors. They will be available throughout the U.S. and Canada within weeks.
"We are pleased to be able to make these much-needed tests available to our customers in the U.S. and Canada," said John Goetz, Vice President of Bio-Rad's Clinical Diagnostics Group. "These licensing approvals come at a critical time as public health concerns over the safety of the blood supply increase."
Hepatitis B is the most common liver infection in the world. It affects an estimated 400 million people and is the leading cause of liver cancer. The World Health Organization estimates that the virus leads to more than one million deaths every year. It is transmitted through blood and other bodily fluids through direct contact with infected blood, unprotected sex, drug use, and is also passed from infected mothers to their offspring during birth. Hepatitis B has become a major public health problem worldwide, with significant transmission of the virus occurring through the use of contaminated donor blood and plasma. Effective screening can aid in the prevention of the virus.
Bio-Rad's new Hepatitis B test, the HBsAg EIA 3.0, is licensed for blood screening and for diagnostic testing of human serum, plasma and cadaveric serum specimens. The HBsAg Confirmatory Assay 3.0 is approved for confirmatory use on reactive specimens. These tests are currently the most sensitive Hepatitis B tests available in the U.S. Bio-Rad also produces a variety of other diagnostic test kits used for HIV, blood viruses, and autoimmune diseases, as well as tests for the detection of genetic disorders and food-borne pathogens like listeria, salmonella and BSE (bovine spongiform encephalopathy or mad cow disease).