Comparison of Four Chimeric Antigens and Commercial Serological Assays for the Diagnosis of Trypanosoma cruzi Infection.

Chagas disease (CD), a neglected tropical disease caused by Trypanosoma cruzi, is a significant public health issue particularly in Latin America, affecting millions worldwide. Diagnosis is a challenge owing to the genetic diversity of T. cruzi and the complexities involved in selecting antigens for the detection of anti-T. cruzi antibodies. This study evaluated four chimeric recombinant antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3, and IBMP-8.4) designed to enhance diagnostic accuracy by addressing assay variability. We compared the diagnostic performance of these chimeric antigens using indirect ELISA as a diagnostic platform, with three commercial serological assays in Brazil, analyzing 100 serum samples from individuals with confirmed CD and 86 from non-infected controls. The results revealed that all assays and antigens demonstrated an area under the receiver operating characteristic curve of 100%, signifying their exceptional ability to distinguish between CD-positive and CD-negative samples. Notably, the chimeric antigens achieved 100% sensitivity, specificity, accuracy, and kappa index, equaling or surpassing the commercial assays. This research highlights the efficacy of IBMP chimeric antigens as reliable diagnostic tools for CD, suggesting their potential integration into commercial diagnostic platforms to enhance the accuracy and reliability of CD detection.