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FDA Approval For Abbott Prism Chagas Screening Test

FDA has approved Abbott Prism Chagas, a second test to screen blood, tissue and organ donors for a blood-borne parasite Trypanosoma cruzi (T cruzi) that causes Chagas disease, a parasitic infection.

Abbott Prism Chagas [T cruzi (E coli, Recombinant) Antigen] detects antibodies to T cruzi. The test is manufactured by Abbott Laboratories, based in Abbott Park, Ill. It is a fully automated and sensitive and specific test for the detection of antibodies to T cruzi.

According to Abott, the assay is intended as a screen to detect antibodies to T cruzi in serum or plasma specimens obtained from donors of whole blood and blood components and other living donors. It is also intended for use to screen organ donors when serum and plasma specimens are obtained while the donor’s heart is still beating and in testing blood specimens to screen cadaveric donors.

Reportedly, national screening of the blood supply was instituted in early 2007, and more than 1,000 donors with T cruzi infection have been identified within the past three years of testing.

Karen Midthun, acting director of FDA’s Center for Biologics Evaluation and Research, said: “Screening for T cruzi is an important safety measure to help protect our blood supply and help prevent the spread of Chagas disease.”