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FDA NEWS RELEASE

For Immediate Release: Sept. 18, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

FDA Approves Donor Screening Test for Antibodies to HIV

The U. S. Food and Drug Administration today announced approval of the Abbott Prism HIV O Plus assay, as a screening tool designed to detect the presence of certain antibodies to HIV. The 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. Both types have been detected in the United States and Europe.

The Abbott Prism HIV O Plus assay detects antibodies to HIV type 1, groups M and O, and HIV type 2. It is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.

The Abbott Prism HIV O Plus assay is licensed to screen donated blood and blood specimens from other living donors for these specific types of HIV and subgroups of HIV type 1. The assay is also licensed to screen specimens from organ donors when specimens are obtained while the donor’s heart is still beating and from cadavers. Positive results from the screening test require confirmation from supplemental tests.

The Abbott Prism HIV O Plus assay and the Abbot Prism system are manufactured by Abbott Laboratories, Abbott Park, Ill.

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