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The U.S. Food and Drug Administration (FDA) today approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a serious and potentially fatal parasitic infection. The test, called the ORTHO T. cruzi ELISA Test System, detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite and is the first such test approved by FDA.

Infection can be severe in people whose immune systems are suppressed, such as organ transplant recipients. Concerns about the potential for transfusion and organ transmitted Chagas disease in the United States have heightened due to the increase in the number of U.S. residents who previously lived in countries where the infection is common. This new test identifies infected donors and therefore can reduce the risk of disease transmission through blood transfusion or organ transplantation.

In studies reviewed by FDA, the test was found to be accurate 99% or more of the time—detecting 198 out of 199 blood specimens from individuals believed to be infected. In field trials of over 70,000 donor samples, the number of individuals falsely identified as positive was extremely small, only 2-3 per 100,000 test results.

In addition to screening people who donate whole blood, this test is intended for use in screening plasma and serum samples from organ, cell and tissue donors. At this time, the test is not approved to diagnose the disease.

The ORTHO T. cruzi ELISA Test System is manufactured by Ortho-Clinical Diagnostics, Inc., Raritan, NJ