The Food and Drug Administration has approved Bio-Rad Laboratories’ Genetic Systems HIV-1/HIV-2 Plus O EIA for use on the Ortho SummitTM System.
The assay is used for the detection of antibodies to Human Immunodeficiency Virus type 1 (groups M and O) and type 2 in human serum and plasma, and is indicated for the screening of the blood supply for HIV infection. This is the first blood donor screening HIV antibody test with claims for HIV-1 group O detection that has been approved for use with a fully automated system in the United States.
The FDA had previously requested that the industry include HIV-1 group O detection, a strain the Centers for Disease Control first reported in the US in 1996, in future HIV tests for blood donor screening.
The Ortho Summit System fully automates the processing of blood donation screening assays and ensures stringent test standards are met and all critical functions are monitored, controlled, and documented.