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The US 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 US residents are HIV-positive, although approximately 20 percent are
unaware of their infection. The United States records approximately 50,000 new
HIV infections annually.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus.
To learn more about The Friends of
AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
