September 21, 2009
FDA OKs second HIV donor screening test
The U. S. Food and Drug Administration says it has approved the second screening test that detects HIV antibodies in donated blood and in organ transplants.
The federal agency said the new test -- the Abbott Prism HIV O Plus assay -- is one of five assays that run on the fully automated Abbott Prism System.
The FDA said the newly approved test detects antibodies to HIV type 1, groups M and O, and HIV type 2. It's the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.
Positive results from the screening test require confirmation from supplemental tests, officials said.
The Abbott Prism HIV O Plus assay and the Abbot Prism system are manufactured by Abbott Laboratories of Abbott Park, Ill.