Rapid High-Sensitivity Detection of Antibodies to Trypanosoma cruzi With a Recombinant Tc24 Antigen-Based Magneto-Immunoassay: A Pilot Study

Abstract

The diagnosis of chronic Chagas disease is challenging due to the wide genetic diversity of Trypanosoma cruzi, the causative agent of Chagas disease, and low levels of parasitemia, resulting in low sensitivity and accuracy with existing diagnostics. We report a magneto-immunoassay that employs dually labeled magnetic beads incorporating a recombinant Tc24 antigen, which is homologous across multiple discrete typing units of T cruzi. In this pilot study, 102 serum samples from 7 endemic countries were tested by this magneto immunoassay, revealing its ability to distinguish Chagaspositive from Chagas-negative cases more accurately and faster than a standard Tc24-based immunoassay. We developed a Tc24-based magneto-immunoassay for highsensitivity detection of anti–Trypanosoma cruzi IgG. Clinical serum samples from multiple Chagas-endemic countries were tested, revealing its ability to distinguish Chagas-positive from Chagas-negative cases more accurately and faster than a standard Tc24-based immunoassay.