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U.S. Department of Health and Human Services

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First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies approved

On August 8, 2013, the Food and Drug Administration approved the Alere Determine HIV-1/2 Ag/Ab Combo assay, which is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection.

The assay is the first FDA-approved rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens, allowing earlier diagnosis of HIV infection.

The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be tested in traditional health care settings.

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.

Earlier diagnosis of HIV infection allows individuals to seek medical care sooner.  Earlier diagnosis during the acute stage of infection may also help reduce further HIV transmission.  

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.

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 Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, Ltd. (an Alere, Inc. company) of Yavne, Israel.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration