Assay Is Now Available in Mexico and Countries That Accept CE Mark

Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, Monday announced the introduction of its next-generation Anti-T. cruzi assay, with CE Mark approval and approval for use in Mexico. Ortho’s VITROS® Anti-T. cruzi assay offers best-in-class sensitivity which is key to the early detection of Chagas disease, and best-in-class specificity, valued by blood banks.

Trypanosoma cruzi /CDC
Trypanosoma cruzi /CDC

“We’re committed to expanding our menu with new and innovative offerings,” said Jennifer Paine, Chief Product Portfolio and Quality, Regulatory and Compliance Officer at Ortho. “The launch of Ortho’s VITROS® Anti-T. cruzi assay will strengthen our VITROS® donor screening solution, allowing us to serve more blood banks.”

The World Health Organization (WHO) estimates that approximately 7-8 million people worldwide are infected with Trypanosoma cruzi, a blood-borne protozoan parasite that causes Chagas disease. With its incapacitating effects and mortality, this disease is one of the biggest public health problems in Latin America. Since human transmission occurs primarily through blood transfusions and organ transplants from infected donors, testing for Trypanasoma cruzi has become mandatory for blood screening in Latin America and parts of Europe.

Ortho’s VITROS® Anti-T. cruzi assay is approved for use on the VITROS® ECi/ECiQ Immunodiagnostic System, VITROS® 3600 Immunodiagnostic Systems, VITROS® 5600 Integrated System and the  next-generation VITROS® XT 7600 Integrated System.