Tropical medicine & international health : TM & IH · 2025
Diagnostic Performance of Chimeric Recombinant Antigens of Trypanosoma cruzi for Identifying Chagas Disease in Samples From Rio Grande do Sul.
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Silva Ângelo Antônio Oliveira, de Leon Ítalo Ferreira, de Jesus Felipe Silva Santos, Sampaio Daniel Dias, Voigt André Luis Bartz, Pinheiro Natália Berne, Bottari Nathieli Bianchin, Castaño-Barrios Leda Margarita, Celedon Paola Alejandra Fiorani, Zanchin Nilson Ivo Tonin, Marchini Fabricio Klerynton, Berne Maria Elisabeth Aires, Santos Fred Luciano Neves
Аннотация
BACKGROUND: Chagas disease, caused by Trypanosoma cruzi, remains a significant public health challenge in Latin America, with diagnostic limitations hindering control efforts.
AIM: Our study aimed to assess the diagnostic performance of four chimeric recombinant T. cruzi antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3 and IBMP-8.4) in a highly endemic region in southern Brazil.
METHODS: Serum samples from 333 individuals residing in Canguçu, Rio Grande do Sul, were tested using an in-house ELISA platform. We assessed the sensitivity, specificity, accuracy, and diagnostic odds ratio (DOR) of individual and combined IBMP antigens through serial and parallel testing strategies.
RESULTS: All antigens exhibited 100% specificity and high accuracy (≥ 93.4%), with IBMP-8.1 and IBMP-8.4 showing the best overall performance (sensitivities of 80.0% and 76.7%; DORs of 109,136 and 89,659, respectively). Parallel testing using the combinations IBMP-8.1 + IBMP-8.3 and IBMP-8.1 + IBMP-8.4 achieved ≥ 95% sensitivity and > 99% accuracy.
CONCLUSIONS: These findings support the use of IBMP chimeric antigens, particularly in combination, as reliable tools for Chagas disease diagnosis and surveillance, and highlight the importance of region-specific validation to ensure diagnostic equity in diverse endemic settings.
AIM: Our study aimed to assess the diagnostic performance of four chimeric recombinant T. cruzi antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3 and IBMP-8.4) in a highly endemic region in southern Brazil.
METHODS: Serum samples from 333 individuals residing in Canguçu, Rio Grande do Sul, were tested using an in-house ELISA platform. We assessed the sensitivity, specificity, accuracy, and diagnostic odds ratio (DOR) of individual and combined IBMP antigens through serial and parallel testing strategies.
RESULTS: All antigens exhibited 100% specificity and high accuracy (≥ 93.4%), with IBMP-8.1 and IBMP-8.4 showing the best overall performance (sensitivities of 80.0% and 76.7%; DORs of 109,136 and 89,659, respectively). Parallel testing using the combinations IBMP-8.1 + IBMP-8.3 and IBMP-8.1 + IBMP-8.4 achieved ≥ 95% sensitivity and > 99% accuracy.
CONCLUSIONS: These findings support the use of IBMP chimeric antigens, particularly in combination, as reliable tools for Chagas disease diagnosis and surveillance, and highlight the importance of region-specific validation to ensure diagnostic equity in diverse endemic settings.