FDA Approves First HIV-1/2 Ag/Ab Combo Diagnostic Test

The FDA approved Orgenics's Alere Determine HIV-1/2 Ag/Ab Combo test, the first rapid HIV test for the detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. This is the first test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

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This test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for blood donor screening. It is approved for use as a diagnostic aid of HIV-1 and HIV-2 infection.

The detection of HIV-1 antigen allows earlier detection of HIV-1 infection than testing for HIV-1 antibodies alone. Alere Determine Combo test can distinguish acute vs. established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1/2 antibodies.

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HIV-1 is responsible for most HIV infections throughout the world whereas HIV-2 is found primarily in West Africa.

For more information call (877) 441-7440 or visit Alere.com/us