Abbott Announces FDA Approval for New Chagas Test

Abbott has announced that its new Chagas in vitro diagnostic test has received approval from the U.S. Food and Drug Administration (FDA).

Chagas disease is caused by the T.cruzi parasite and is endemic throughout much of Mexico, Central America and South America. The disease is transmitted to animals and people through the infected feces of insects. Infection may also occur congenitally through transfusion of contaminated blood products or through an organ transplant from an infected donor. Chagas disease develops from an acute to a chronic illness, which can cause constipation, digestive problems, abdomen pain, and abnormal heart rhythms or heart failure which can prove fatal.

The ABBOTT ESA Chagas is the first FDA-approved supplemental test that detects antibodies to Trypanosoma cruzi (T. cruzi), a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, also known as a "kissing bug." The U.S Centers for Disease Control and Prevention (CDC) estimates that as many as 11 million people worldwide are infected with Chagas disease, with more than 300,000 of those infected living in the US.

Following concerns over the transmission of Chagas disease through blood transfusion, the FDA mandated donor screening in 2007. The American Association of Blood Banks (AABB) Chagas Biovigilance Network reports that nearly 1,500 donors with Chagas disease have been identified in the four years since mandatory donor screening was implemented.

"Chagas disease can cause significant and debilitating symptoms for those infected," said John Coulter, divisional vice president, Diagnostics, Abbott. "The new ABBOTT ESA Chagas test provides organizations that screen blood with an approved testing method to help keep the blood supply safe and enable them to confidently counsel infected donors."

The ABBOTT ESA Chagas is an in vitro enzyme strip assay (ESA) intended for the qualitative detection of T. cruzi in human serum and plasma specimens. The test is intended for use as an additional, more specific test on human serum or plasma specimens found repeatedly reactive using a licensed screening test.