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Medical News

Rapid HIV Test Approved by U.S. FDA

August 13, 2013

The U.S. Food and Drug Administration (FDA) has approved the Alere Determine HIV-1/2 AF/Ab Combo test that can detect an HIV infection and distinguish between an early infection and an established HIV infection from "human serum, plasma, and venous or fingerstick whole-blood specimens." Developed by Alere's Israel-based Orgenics subsidiary, the Alere Determine rapid HIV test not only would provide faster HIV diagnosis, but also would be relatively simple to use in remote high-incidence areas such as sub-Saharan Africa.

The Alere Determine rapid test is able to detect simultaneously the HIV-1 p24 antigen, a signal of HIV-1 infection, and the presence of HIV-1 and HIV-2 antibodies usually present in established infections. Most worldwide AIDS cases developed from HIV-1 infections, and HIV-2 infections have occurred mostly in West Africa. The Alere Determine test is not useful for screening blood donors because it does not distinguish between HIV-1 antibodies and HIV-2 antibodies.

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See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Rapid HIV Testing

Reader Comments:

Comment by: dick keiser (fort lauderdale) Wed., Aug. 14, 2013 at 9:40 am UTC
so why does the CDC continue to report as a matter of fact the 1:5 that don't know status and the 50,000 new infections a year. We could end or at least traumatically lower new infections if anyone cared! this is now the 12th year of these 'routine' statistics.
HIV is now 50 billion a year in the US .. my latest blog will suggest the epidemic is not sustainable financially at current level

and passive hiv testing is not going to route out the 1:5 and get them on anti-virals and non-infectious .. neither are men who last tested negative, continuing to sero sort for bb sex
dick keiser huffington post, author upcoming book
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