- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves First Rapid Diagnostic Test for HIV-1 Antigen and HIV-1/2 Antibodies
Test allows infected individuals to seek medical care sooner (August 8)
The FDA has approved the Alere Determine HIV-1/2 Ag/Ab Combo test (Orgenics, Ltd.) — the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 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 undergo testing in traditional health care settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and it is not intended to be used to screen blood donors.
The detection of HIV-1 antigen permits earlier detection of HIV-1 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.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.”
HIV damages the body’s defense mechanisms by destroying certain blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified, HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.
Source: FDA; August 8, 2013.