FDA APPROVES FIRST RAPID DIAGNOSTIC TEST TO DETECT BOTH HIV-1 ANTIGEN AND HIV-1/2 ANTIBODIES "This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.” HIV infection can result in the development of Acquired Immune Deficiency Syndrome, or AIDS. HIV damages the body’s defense mechanisms by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified, HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe. The Centers for Disease Control and Prevention estimates that each year approximately 50,000 people are infected with HIV in the United States. Of the more than 1 million people living with HIV in the United States, approximately 20 percent of those people have not been diagnosed. The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, Ltd. (an Alere, Inc. company) of Yavne, Israel. Consumer Inquiries: 888-INFO-FDA, [email protected]
Posted on: Thu, 15 Aug 2013 03:27:25 +0000
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