Rapid HIV test approved by FDA

The US Food and Drug Administration (FDA) has approved a pioneering rapid HIV test that can simultaneously detect HIV-1 p24 antigen as well as antibodies to both HIV Type 1 and Type 2.

As well as providing faster diagnosis of HIV infection, the new test is also relatively simple to administer in remote ‘outreach’ settings. These two advantages have huge implications for combating AIDS in sub-Saharan Africa and other underdeveloped areas of the world.

The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Alere’s Israel-based Orgenics subsidiary. It can detect HIV antibodies and the HIV-1 p24 antigen in human serum, plasma, and venous or fingerstick whole-blood specimens.

Early tip-off

The HIV-1 p24 antigen test is not definitive but can act as an early ‘tip-off’ to the presence of HIV-1 infection.

When combined with the presence or absence of HIV-1 and HIV-2 antibodies, the combined test can differentiate an acute onset infection from a more established one.

In acute onset the blood specimen will test positive for HIV-1 p24 antigen but negative for the antibodies. In an established infection, the reverse is usually the case.

The test does not distinguish between antibodies to HIV-1 and HIV-2 so is not useful for screening of blood donors.


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