Evaluation of InBios Chagas Detect Fast, a Novel Enzyme-Linked Immunosorbent Assay for the Detection of Anti-Trypanosoma cruzi Antibodies

Chagas disease (CD), caused by the protozoan parasite Trypanosoma cruzi, affects an estimated 6 million people worldwide, predominantly in Latin America (1). Up to 30% of cases will manifest as cardiac disease, including conduction disorders and heart failure, and/or gastrointestinal motility disorders, with high resulting morbidity and mortality (2, 3). Diagnosis of chronic T. cruzi infection requires concordant positive results by two distinct serological tests. No single assay has demonstrated sensitivity and specificity adequate enough to be used alone (4, 5).