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Rapid diagnostic test approved for HIV-1, HIV-2.

The first rapid diagnostic test to simultaneously detect the HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 has earned Food and Drug Administration approval.

Like other HIV tests, the Alere Determine HIV-1/2 Ag/Ab Combo test can detect antibodies to HIV-I, the most common type of HIV, and HIV-2 in human serum, plasma, or venous and fingerstick blood specimens.

But the new test also can distinguish acute HIV-1 infection from established HP/-i infection, if the blood specimen is positive for HIV-1 p24 antigen but negative for HIV-1 and HIV-2 antibodies.

The new test could be a crucial tool for identifying HIV-infected individuals who might not be able to be tested in traditional health care settings, said Dr. Karen Midthun director of the FDA's Center for Biologics Evaluation and Research, in a statement.

Orgenics makes the Alere Determine HIV-1 / 2 Ag/Ab Combo test.
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Author:Bock, Mike
Publication:Internal Medicine News
Date:Sep 1, 2013
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