FDA Approval for Abbott Fully Automated Blood Screening for HIV-1/HIV-2

Abbott has received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully automated blood screening test for HIV-1/HIV-2. This test can be used by laboratory professionals to screen individual donors of blood and plasma for antibodies to human immunodeficiency virus type 1 Groups M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection.

The assay, which provides laboratories a fully automated test compared to the current method, runs on the ABBOTT PRISM system, which can run 160 samples per hour, making it possible to test more than 1,200 samples in an eight-hour shift. Speed and efficiency are important to labs given the volume of blood that is screened each year. According to the American Association of Blood Banks (AABB), eight million volunteers donate about 15 million units of whole blood each year in the United States alone. Each donated unit of blood must be tested for infectious diseases including hepatitis, HIV and other retroviruses. Abbott´s hepatitis and retrovirus tests are used thousands of times every day around the globe for blood screening and diagnostic testing.

With this approval, Abbott now has a complete panel of hepatitis and retrovirus tests on the ABBOTT PRISM system which includes the following assays: a hepatitis B core test (ABBOTT PRISM HBcore); a hepatitis B surface antigen test (ABBOTT PRISM HBsAg along with ABBOTT PRISM HBsAg Confirmatory); a hepatitis C test (ABBOTT PRISM HCV); and a human T- lymphotropic virus test (ABBOTT PRISM HTLV-I/HTLV-II). Used in more than 30 countries, the ABBOTT PRISM is used to screen the majority of the blood supply in the United States and around the world.