Print“Having a new rapid test may help boost the number of earlier diagnoses, prompting people to seek earlier medical care, and possibly reduce additional HIV transmission.”
The U.S. Food and Drug Administration approved the first blood test capable of quickly identifying HIV-infections in as little as 12 days after infection and without the need for a lab.
About 20 percent of the one million people living with HIV in the United States are undiagnosed. Having a new rapid test may help boost the number of earlier diagnoses, prompting people to seek earlier medical care, and possibly reduce additional HIV transmission, says Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
The test, marketed as Determine and sold by Massachusetts-based diagnostics company Alere, takes 20 to 30 minutes after blood collection to yield results.
Determine is the first FDA-approved test to independently distinguish a specific antigen to HIV-1, the virus responsible for most HIV infections throughout the world, and HIV antibodies in a single test. That permits earlier detection of HIV-1 infection than possible by testing for HIV-1 antibodies alone, something that requires a wait of 20 to 45 days after infection, versus just 12 to 26 days for antigen-based detection.
HIV-2, the other variant of the virus that Determine tests for, is found primarily in West Africa. However, cases of HIV-2 infection have been reported in North America and Europe.
The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics (an Alere company) of Yavne, Israel.
August 08, 2013
http://www.burrillreport.com/article-test_sees_hiv_early_fast.html
.gif)
