10:22pm Tuesday 19 September 2017

FDA Approves Donor Screening Test for Antibodies to HIV

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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Media Inquiries: Peper Long, 301-796-4671
Consumer Inquiries: 1-888-INFO-FDA


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