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.

There are two types of HIV: HIV type 1 consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa. HIV type 2 is found mostly in West Africa, but both types have been detected in the United States and Europe.

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.