The test is called ORTHO T. cruzi ELISA Test System and is manufactured by Ortho-Clinical Diagnostics, Inc., Raritan, NJ. This is the first Trypanosoma cruzi parasite detection 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,"Â 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."Â
There are about 11 million Trypanosoma cruzi parasite infected people around the world most of all live in Mexico, Central and South America. Most of the infected US residents previously lived in the mentioned countries.
The infection can be transmitted through blood transfusions or organ transplants or bite of an infected insect. The symptoms of the disease are usually unrecognized in the first level, but the disease goes on during the whole life and kills 50,000 infected people each year worldwide.
"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,"Â said Jay Epstein, MD, Director of the Office of Blood Research and Review in FDA's Center for Biologics Evaluation and Research (CBER).
FDA's studies say that the test is 99 % accurate: 199 infected patients where tested, and the test showed 198 Trypanosoma cruzi parasite positives. 100.000 donor blood samples were tested and only 3 of them were falsely shown as positive.
By Ruzan Harutyunyan for HULIQ
Posted December 14th, 2006 by ruzik_tuzik
