News and Features
FDA Approves First Rapid Diagnostic Test for Simultaneous Detection of HIV-1 Antigen and Both HIV-1 and HIV-2 Antibodies
“The U.S. Food and Drug Administration today [August 8, 2013] approved 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. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.
“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. 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.
“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.”
More information is available:
- FDA: Press release
CDC Webpage Offers Information on Preexposure Prophylaxis (PrEP)
CDC recently updated the “Basic Information on PrEP” webpage. The webpage offers helpful, easy-to-understand information on preexposure prophylaxis, or PrEP, which is a prevention option for people who are at high risk of getting HIV. Topics include why a person may want to consider taking PrEP, how well PrEP works, and how a person can start PrEP. For more information, visit the CDC PrEP webpage.