First rapid HIV diagnostic test approved by US FDA

The first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies has been approved by the US Food and Drug Administration.

The Alere Determine HIV-1/2 Ag/Ab Combo test has been approved for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. The test is manufactured by Orgenics, Ltd, which is an Alere company, situated in Isreal.

“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner. Earlier diagnosis may also help to reduce additional HIV transmission.”

Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

HIV infection can result in the development of AIDS. HIV damages the body’s defense mechanisms by destroying specific blood cells, which are crucial to helping the body fight diseases. HIV-1 is responsible for most HIV infections throughout the world, while HIV-2 is found primarily in West Africa.

Approximately 50,000 people each year are infected with HIV in the US, while in 2011 it was estimated that there were over 34 million people living with HIV/AIDS worldwide, according to the World Health Organisation.

 

Related news:

U.S. health regulators approve Alere’s HIV test (Reuters)

Reference links:

FDA press release

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