Rapid HIV Test Approved by FDA

A pioneering rapid human immunodeficiency virus (HIV) test has been approved by the US Food and Drug Administration (FDA).

The test can that can simultaneously detect HIV-1 p24 antigen as well as antibodies to both HIV Type 1 and Type 2 and is also relatively simple to administer in remote poor resource settings.


The Alere Determine HIV-1/2 Ag/Ab Combo test (Waltham, MA, USA) is manufactured by their subsidiary Orgenics (Yavne, Israel). It can detect HIV antibodies and the HIV-1 p24 antigen in human serum, plasma, and venous or fingerstick whole-blood specimens. 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. 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. The test does not distinguish between antibodies to HIV-1 and HIV-2, so is not useful for screening of blood donors.

HIV infection can lead to acquired immune deficiency syndrome (AIDS) damaging natural defense mechanisms by destroying CD4+ T cells, a type of white blood cell crucial to helping the body fight diseases. Worldwide, cases of AIDS stem from HIV-1 infection, while HIV-2 infections have mostly been seen in West Africa.

Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research (Silver Spring, MD, USA) said, “This new test would enable HIV-infected people to receive medical care sooner thanks to earlier detection in outreach settings. Earlier diagnosis may also help to reduce additional HIV transmission." It is thought that more than a million people are living with HIV infection in the USA, of whom one in five have not yet been diagnosed.

Related Links:
Alere
Orgenics