In December 2006, Ortho-Clinical Diagnostics received FDA approval for the ORTHO(R) T.cruzi ELISA Test System. The test detects antibodies to the Trypanosoma cruzi parasite. In clinical trials, the ORTHO(R) T.cruzi ELISA Test System demonstrated 100 percent sensitivity with parasite positive and serological positive populations, and demonstrated an observed specificity of greater than 99.99 percent. When the FDA approved the test, the agency said: "This new test identifies infected donors and therefore can reduce the risk of disease transmission through blood transfusion or organ transplantation."
The company will seek FDA approval to expand use of its test for Chagas' disease in tissue and cell transplants (cadaveric testing) and for general diagnostic purposes. Physicians and patients with questions about Chagas' disease are encouraged to visit the CDC's Web site at http://www.cdc.gov. For the latest data and a state-by-state accounting of blood donations testing positive for Chagas', visit the AABB's Chagas' Disease Biovigilance Network on the Web. Maps are updated weekly. http://www.aabb.org/Content/Programs_and_Services/Data_Center/Chagas /chagas.htm. (Due to length of URL, please cut and paste into browser.)
(1) Updated CDC estimates as of March 2007. Earlier CDC estimates said the
number of people infected with Chagas' disease worldwide ranged from
16 to 18 million. Experts suggest that the decline may be
attributable, at least in part, to effective prevention and
intervention programs initiated in central and south America
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading
provider of high-value diagnostic solutions for the global health care
community. Committed to developing the most advance
|SOURCE Ortho-Clinical Diagnostics, Inc.|
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