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.
FDA's Center for Biologics Evaluation and Research Director Karen Midthun predicted the test could help in identifying HIV earlier in "outreach settings." Early detection could help newly infected people receive medical care sooner and potentially could prevent HIV transmission.
CDC estimated that more than a million U.S. residents are HIV-positive, although approximately 20 percent are unaware of their infection. The United States records approximately 50,000 new HIV infections annually.