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Published On: Fri, Aug 9th, 2013

FDA approves the Alere Determine HIV-1/2 Ag/Ab Combo test, detects antigen and antibody simultaneously

The U.S. Food and Drug Administration Thursday approved the first rapid Human Immunodeficiency Virus (HIV) test 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. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.
Image/CDC/ Jim Gathany

Image/CDC/ Jim Gathany

The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.

Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test, can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-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.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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