New Diagnostic Test for Chagas Launched

A new diagnostic test for Chagas disease, which is caused by the protozoan parasite Trypanosoma cruzi, has been launched in Europe.

The diagnostic test for Chagas disease demonstrated 100% sensitivity to all geographically diverse samples tested and specificity of more than 99.99% in blood donors' samples. Ortho-Clinical Diagnostics (Raritan, NJ, USA), a Johnson and Johnson company, developed the test, which will be used for screening blood donations and testing blood donors who have returned from areas endemic for Chagas disease, and whose blood has not been accepted in the past. The test will also be used for serodiagnosis of Chagas disease.

Chagas disease is usually transmitted by contact with the feces of an infected triatomine ("cone nose” or "kissing”) bug. Transmission can also occur through blood transfusion and organ transplantation, and congenitally through passage of parasites across the placenta. It is endemic to South America.

Acquisition of infection is rare in the United States and Europe although some cases have been detected. An estimated 11 million people are infected worldwide. Acute infection is usually asymptomatic but may be accompanied by local swelling at the site of inoculation, fever, and in 5-10% of cases, meningoencephalitis, myocarditis, or both. An asymptomatic phase follows the acute infection and lasts for life in 70-80% of cases. A chronic phase occurring 10-20 years after initial exposure can cause an enlarged heart or digestive tract.

Ortho-Clinical Diagnostics provides diagnostic solutions for the global health care community and provides blood screening and typing products that help ensure the safety of the world's blood supply. The company is committed to developing advanced tests for early detection or diagnosis of disease.



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