FDA APPROVES FIRST TEST TO SCREEN BLOOD DONORS FOR CHAGAS DISEASE

The FDA's Center for Biologics Evaluation and Research (CBER) has approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a potentially fatal parasitic infection.

The Ortho T. cruzi Elisa Test System, manufactured by Ortho-Clinical Diagnostics, detects antibodies to the Trypanosoma cruzi parasite. CBER approved the test Dec. 13.

In addition to screening donated whole blood, the test can screen plasma and serum samples from organ, cell and tissue donors. The test is not currently approved to diagnose the disease, the FDA said.

"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," the FDA said. "Most have no symptoms or signs of the disease, which is usually acquired from an insect bite but also can be transmitted through blood transfusions or organ transplants."

Early infection may lead to organ damage, "particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide," the FDA said. Infection can also be severe in people whose immune systems are suppressed, such as organ transplant recipients.

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

The notice can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01524.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01524.html).