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November 24, 2011

FDA clears Abbott Chagas disease test

The US Food and Drug Administration has approved a test developed by Abbott Laboratories to detect antibodies to Trypanosoma cruzi, the cause of Chagas disease.

The US Food and Drug Administration has approved a test developed by Abbott Laboratories to detect antibodies to Trypanosoma cruzi, the cause of Chagas disease.

The Abbott ESA Chagas test is an in vitro enzyme strip assay that qualitatively identifies antibodies.

Karen Midthun, director of the FDA Center for Biologics Evaluation and Research, said that the test will help healthcare specialists to provide counselling to donors with positive screening test results.

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