Abbott receives CE Mark for rapid diagnostic HBV surface antigen test

Abbott received CE Mark for the company’s Determine HBsAg 2 test, a rapid diagnostic test designed to detect hepatitis B surface antigen, according to a press release.

“To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia,” Damian Halloran, vice president of Infectious Disease-Emerging Markets at Abbott, said in the release. “The unparalleled sensitivity, portability and ease-of-use of the Determine HBsAg 2 provides life-changing technology that can dramatically scale up testing services so more infected people can know their status and get treatment earlier.”

The Determine HBsAg 2 can be used with serum, plasma or whole blood and provides an analytical sensitivity of 0.1 IU/mL. Results are available in 15 minutes and can be administered easily in any health care setting, according to the release.

The test is now commercially available in Europe, Africa, Asia Pacific and Latin America. Additionally, Abbott has submitted data on the test for WHO prequalification.

Reference: www.abbott.com