FDA Approves Supplemental Test for Chagas Disease

An additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi) has been approved by the U.S. Food and Drug Administration. T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection. The ESA Chagas [Trypanosoma cruzi (e. coli, Recombinant) Antigen], manufactured by Abbott Laboratories, is an in vitro enzyme strip assay for the qualitative detection of antibodies to T. cruzi. While there are currently two donor screening tests licensed to detect antibodies to T. cruzi, this will be the first test licensed as a supplemental test. Chagas disease is spread mainly by bloodsucking insects infected with T. cruzi, but it also can be spread through blood transfusion, organ transplants and from mother to unborn child.