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FDA Approves First Test to Screen Blood Donors for Chagas Disease
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.
“Our blood supply is now extremely safe from diseases once frequently transmitted by blood, such as HIV. However, we are constantly faced with new threats,” said Jesse L. Goodman, MD, MPH, Director of CBER. “Evaluating this test involved a high degree of interaction between FDA scientists, the blood industry and test developers. It is part of an ongoing effort to, wherever possible, identify emerging threats and provide the tools needed to help keep blood safe.”
It is estimated that as many as 11 million people are currently infected by T. cruzi, most commonly in parts of Mexico, Central and South America. Most have no symptoms or signs of the disease. The infection is usually acquired from the bite of an infected insect but also can be transmitted through blood transfusions or organ transplants. Early infection is usually mild and unrecognized, but persists lifelong and may lead to organ damage, particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide. Infection also 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.
“The availability of this test offers an important new safety measure to protect recipients of blood, organs and tissues against a potentially very serious, though uncommon infection,” said Jay Epstein, MD, Director of the Office of Blood Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER).
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