The first rapid human immunodeficiency virus (HIV) test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test has been approved by the US Food and Drug Administration (FDA).
Alere Determine HIV-1/2 Ag/Ab Combo test, manufactured by Orgenics, Ltdof Yavne, Israel, can identify the viruses in human serum, plasma, and venous or fingerstick whole blood specimens.
The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings.
FDA’s Center for Biologics Evaluation and Research director Karen Midthun said: "This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner.
"Earlier diagnosis may also help to reduce additional HIV transmission."
Detection of HIV-1 antigen allows earlier detection of infection than is possible by testing for HIV-1 antibodies alone. The test can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.
However, the FDA has highlighted that the test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.
Two types of HIV have been identified, HIV-1 and HIV-2, the latter is primarily found in West Africa, while the former is responsible for most HIV infections throughout the world. HIV infection can eventually lead to development of immune deficiency syndrome (AIDS).
Photo: Electron micrograph of HIV-1. Image: courtesy of Wikipedia.
