FDA Approves Chagas Disease Screening Test for Blood, Tissue and Organ Donors

Another test to detect Trypanosoma cruzi infection

SILVER SPRING, Md., April 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a second test to screen blood, tissue and organ donors for a blood-borne parasite, Trypanosoma cruzi (T. cruzi), that causes Chagas disease, a serious and potentially fatal parasitic infection.

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The test, called Abbott Prism Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen], detects antibodies to T. cruzi. It is a fully automated and highly sensitive and specific test for the detection of antibodies to T. cruzi.

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 to screen cadaveric donors (those whose hearts are not beating).

"Screening for T. cruzi is an important safety measure to help protect our blood supply and help prevent the spread of Chagas disease," said Karen Midthun, M.D., 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.

Chagas disease is spread mainly by blood-sucking insects infected with T. cruzi. Chagas disease can also be spread through blood transfusion, organ transplants and from mother to unborn child. National screening of the blood supply was instituted in early 2007, and more than 1,000 donors with T. cruzi infection have been identified within the past three years of testing.    

The Abbott Prism Chagas is manufactured by Abbott Laboratories, based in Abbott Park, Ill.

For more information:

Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm126585.htm

Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.htm

Media Inquiries: Shelly Burgess, 301-796-4651, [email protected]

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration