The U.S. Food and Drug Administration (FDA) approved a rapid diagnostic test today for the human immunodeficiency virus (HIV). It’s the first one to simultaneously test for HIV-1 p24 antigens as well as antibodies to HIV-1 or HIV-2 in human serum, plasma, and venous or fingerstick blood samples.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Earlier diagnosis may also help to reduce additional HIV transmission.”
Called the Alere Determine HIV-1/2 Ag/Ab Combo test, it’s the first to test for the p24 capsid protein of HIV, which is the most abundant viral protein out of between 1,500 and 3,000 p24 molecules, while also detecting antibodies of HIV-1 or HIV-2 infections.
By searching for both the infection and any immune responses to it, the FDA says it will be able to identify “HIV-infected individuals who might not be able to be tested in traditional health care settings.”
The test isn’t able to distinguish between antibodies of HIV-1 and HIV-2, and it can’t be used to screen blood donors. But it will be able to distinguish between acute HIV-1 infection and established HIV-1 infection, which is the time between initial infection and the presence of antibodies.
HIV, which can develop into acquired immune deficiency syndrome (AIDS), destroys CD+ T cells that are integral to the body’s disease-fighting mechanisms.
The Centers for Disease Control and Prevention estimates that more than 1.1 million people aged 13 and older have HIV, and that almost 20 percent of them don’t know that they are living with it. In 2011, almost 50,000 people were diagnosed with HIV.