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FDA Approves First Test to Screen Blood Donors for Chagas Disease

Internet URL

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01524.html  

Sponsoring Agency

U.S. Food and Drug Administration

Description

This news release announces the approval by the Food and Drug (FDA) of 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. Concerns about Chagas Disease have heightened due to the increasing number of U.S. residents who previously lived in countries where the disease is common.

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Review Date

12/22/2006