Laboratory evaluation of five rapid diagnostic tests for the serological diagnosis of chronic Trypanosoma cruzi infection in Yucatan, Mexico
- 1IRD: Institut de recherche pour le developpement
Abstract
Chagas disease (CD), caused by Trypanosoma cruzi, is a significant public health challenge in Latin America, where an estimated 70% of infected individuals remain undiagnosed. Rapid diagnostic tests (RDTs) offer a promising solution for new screening strategies, yet their performance has not been systematically assessed in Mexican cohorts. Here, we evaluated the diagnostic performance of five RDTs: Chagas Rapid Test (Certum), Bio-Chagas Rapid Test (Mexlab), BiolineTM Chagas Ab (Abbott), Chagas Rapid Test (Amunet) and Chagas Sero K-SeT (Coris BioConcept). Performance was tested using 79 archived human serum samples from Yucatan. All tests were benchmarked against the diagnostic reference algorithm established by the Mexican Official Norm (NOM), where samples were characterised as positive if they were reactive to [≥] 2 conventional serological assays (Chagatest Lisado, Chagatest Recombinante v4.0 and Chagatest HAI). The RDTs demonstrated variable diagnostic sensitivity. The BiolineTM Chagas Ab test demonstrated the highest sensitivity (97.2%, 95% CI: 85.5 - 99.9; 35/36 positive samples detected) and almost perfect statistical agreement with the NOM reference algorithm ({kappa}= 0.90; p < 0.0001). Similarly, the Chagas Sero K-SeT prototype showed a high sensitivity (91.7%, 95% CI: 77.5 - 98.2; 33/36 positive samples detected) and substantial concordance ({kappa}= 0.87, p < 0.0001) with the NOM-based composite result. In contrast, the remaining RDTs demonstrated low sensitivities (Certum: 0.0%, 95% CI: 0.0-9.7; Mexlab: 5.6%, 95% CI: 0.7-18.7; Amunet: 33.3%, 95% CI: 18.6-51.0), limiting their suitability for CD diagnostic algorithms, at least in Yucatan. Specificity was consistently high across the RDTs, ranging from 93.0% to 100% (95% CIs: 80.9-100). These findings underscore the need to locally validate diagnostic tools. The BiolineTM Chagas Ab and Chagas Sero K-SeT tests met the WHO benchmarks for RDT performance and, if validated in larger cohorts, could strengthen the screening of T. cruzi infection and epidemiological surveillance in Mexico.
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BibTeX
@misc{heslop2026laboratory,
title = {{Laboratory evaluation of five rapid diagnostic tests for the serological diagnosis of chronic Trypanosoma cruzi infection in Yucatan, Mexico}},
author = {R. Heslop and G. Pellegrin and P. Martinez-Vega and C. Teh-Poot and J. Torres-Montero and H. Noh-Pech and K. Dzul-Rosado and F. Puerto-Manzano and A. Gonzalez-Martinez and C. Ibarra-Cerdena and C. Meza-Ayala and O. Valenzuela-Antelo and J. Cruz-Chan and V. Lejon and C. Guzman-Bracho and J. Ortiz and A. Ramos-Ligonio and J. Alonso-Padilla and B. Bucheton and E. Waleckx},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.26.26366472},
url = {https://www.medrxiv.org/content/10.64898/2026.10.26.26366472v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Laboratory evaluation of five rapid diagnostic tests for the serological diagnosis of chronic Trypanosoma cruzi infection in Yucatan, Mexico
AU - R. Heslop
AU - G. Pellegrin
AU - P. Martinez-Vega
AU - C. Teh-Poot
AU - J. Torres-Montero
AU - H. Noh-Pech
AU - K. Dzul-Rosado
AU - F. Puerto-Manzano
AU - A. Gonzalez-Martinez
AU - C. Ibarra-Cerdena
AU - C. Meza-Ayala
AU - O. Valenzuela-Antelo
AU - J. Cruz-Chan
AU - V. Lejon
AU - C. Guzman-Bracho
AU - J. Ortiz
AU - A. Ramos-Ligonio
AU - J. Alonso-Padilla
AU - B. Bucheton
AU - E. Waleckx
PY - 2026
DA - 2026/10/26
PB - medRxiv
DO - 10.64898/2026.10.26.26366472
UR - https://www.medrxiv.org/content/10.64898/2026.10.26.26366472v1
AB - Chagas disease (CD), caused by Trypanosoma cruzi, is a significant public health challenge in Latin America, where an estimated 70% of infected individuals remain undiagnosed. Rapid diagnostic tests (RDTs) offer a promising solution for new screening strategies, yet their performance has not been systematically assessed in Mexican cohorts. Here, we evaluated the diagnostic performance of five RDTs: Chagas Rapid Test (Certum), Bio-Chagas Rapid Test (Mexlab), BiolineTM Chagas Ab (Abbott), Chagas Rapid Test (Amunet) and Chagas Sero K-SeT (Coris BioConcept). Performance was tested using 79 archived human serum samples from Yucatan. All tests were benchmarked against the diagnostic reference algorithm established by the Mexican Official Norm (NOM), where samples were characterised as positive if they were reactive to [≥] 2 conventional serological assays (Chagatest Lisado, Chagatest Recombinante v4.0 and Chagatest HAI). The RDTs demonstrated variable diagnostic sensitivity. The BiolineTM Chagas Ab test demonstrated the highest sensitivity (97.2%, 95% CI: 85.5 - 99.9; 35/36 positive samples detected) and almost perfect statistical agreement with the NOM reference algorithm ({kappa}= 0.90; p < 0.0001). Similarly, the Chagas Sero K-SeT prototype showed a high sensitivity (91.7%, 95% CI: 77.5 - 98.2; 33/36 positive samples detected) and substantial concordance ({kappa}= 0.87, p < 0.0001) with the NOM-based composite result. In contrast, the remaining RDTs demonstrated low sensitivities (Certum: 0.0%, 95% CI: 0.0-9.7; Mexlab: 5.6%, 95% CI: 0.7-18.7; Amunet: 33.3%, 95% CI: 18.6-51.0), limiting their suitability for CD diagnostic algorithms, at least in Yucatan. Specificity was consistently high across the RDTs, ranging from 93.0% to 100% (95% CIs: 80.9-100). These findings underscore the need to locally validate diagnostic tools. The BiolineTM Chagas Ab and Chagas Sero K-SeT tests met the WHO benchmarks for RDT performance and, if validated in larger cohorts, could strengthen the screening of T. cruzi infection and epidemiological surveillance in Mexico.
ER -