FDA Approves Screening Test for Parasitic Disease

FDA's Center for Biologics Evaluation and Research has approved the first blood test for a parasite that causes Chagas disease, an infection that can be deadly. The Ortho T. cruzi ELISA Test System, made by Johnson & Johnson's Ortho-Clinical Diagnostics (Raritan, NJ), detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite. It is believed to have infected 11 million people worldwide, mostly in Latin America.

December 14, 2006

1 Min Read
FDA Approves Screening Test for Parasitic Disease

It is not approved to diagnose the disease but to screen plasma and serum samples from organ, cell, and tissue donors. In trials it was found to be accurate more than 99% of the time, and false positives were extremely rare.

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