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FDA NEWS RELEASE
FDA approves first supplemental test for Chagas disease
The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi). T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection.
The test, called the ABBOTT ESA Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen], is an in vitro enzyme strip assay for the qualitative detection of antibodies to T. cruzi. There are currently two donor screening tests licensed to detect antibodies to T. cruzi; however, this will be the first test licensed as a supplemental test.
“This test will help health care professionals to provide counseling to donors with positive screening test results,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Chagas disease is mainly spread by blood-sucking insects infected with T. cruzi. Chagas disease can also be spread through blood transfusion, organ transplants, and from mother to unborn child. The estimated number of persons living in the United States infected with T. cruzi, and at risk for developing Chagas disease, is 300,000 or more.
More than 5,000 donors with positive test results on a screening test have been identified since national screening of the blood supply was instituted in early 2007.
The Abbott ESA Chagas assay is manufactured by Abbott Laboratories, based in Abbott Park, Ill.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.