FDA Approves Chagas Disease Screening Test

WASHINGTON, May 3 (UPI) — The U.S. Food and Drug Administration has approved a second test to screen blood and tissue for a blood-borne parasite that causes Chagas disease.

The assay — called the Abbott Prism Chagas test — detects antibodies to the parasite Trypanosoma cruzi.

The FDA said the assay is intended as a screen to detect antibodies to T. cruzi in serum or plasma specimens obtained from donors of whole blood and blood components and other living donors. It is also intended for use to screen organ donors when serum and plasma specimens are obtained while the donor’s heart is still beating and in testing blood specimens from cadaveric donors.

“Screening for T. cruzi is an important safety measure to help protect our blood supply and help prevent the spread of Chagas disease,” said Dr. Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research.

An estimated 300,000 people in the United States are infected with Chagas disease — a serious and potentially fatal disease spread mainly by blood-sucking insects infected with T. cruzi. Officials said it can also be spread through blood transfusion, organ transplants and from mother to unborn child.

The Abbott Prism Chagas test is manufactured by Abbott Laboratories of Abbott Park, Ill.

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