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FDA approves HIV antibodies screening test

The FDA has approved the Abbott Prism HIV O Plus assay as a screening tool to detect HIV in blood and organ donations

The US Food and Drug Administration (FDA) has approved the Abbott Prism HIV O Plus assay as a screening tool designed to detect the presence of antibodies to HIV type 1, groups M and O and HIV type 2.

The assay is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O, and is one of five assays that run on the fully automated Abbott Prism System. During the past decade, fourth-generation assays have been developed that combine antigen and antibody detection in a single assay.

The test runs on Abbott Laboratories' Illinois-based system and will be used to screen for HIV in blood and organ donations.

HIV group M is the most common subgroup of the virus in the US and group O occurs primarily in West Africa.

21st September 2009


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