FDA licensing of donor screening test for antibodies to HIV type 1, groups M and O, and HIV type 2

The Food and Drug Administration (FDA) licensed, on September 18, 2009, the Abbott Prism HIV O Plus assay, a new screening tool designed to detect the presence of antibodies to the two types of the virus that causes AIDS, HIV 1 and HIV 2. Both types can be transmitted by sexual contact, through blood, and by mother to child transmission. 

The new assay is one of five assays that run on the fully automated Abbott Prism System. 

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 (e.g., organ or tissue 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. 

Richard Klein 
Office of Special Health Issues 
Food and Drug Administration 

Kimberly Struble 
Division of Antiviral Drug Products 
Food and Drug Administration