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FDA approves new supplemental test to detect Chagas’ disease
The FDA has approved an additional, more specific test on human serum or plasma specimens that are positive for antibodies to Trypanosoma cruzi, the cause of Chagas’ disease, according to a press release.
“This test will help health care professionals to provide counseling to donors with positive screening test results,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.
Other than the two donor screening tests that are currently licensed to detect antibodies to T. cruzi, the new test (ESA Chagas assay, Abbott Laboratories) is an in vitro enzyme strip assay for the qualitative detection of antibodies to T. cruzi and is the first-ever licensed supplemental test.
“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,” according to the press release. “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.”
For more information, please visit www.FDA.gov.
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