Diagnostic validity of ELISA-IgM, DPP® rapid test, and MAT for leptospirosis diagnosis in Brazilian reference laboratories: a latent class analysis
8 affiliations
- 1Universidade Federal de São João del-Rei
- 2Fundação Oswaldo Cruz, Instituto Carlos Chagas
- 3Universidade Federal da Bahia, Departamento de Estatística, Instituto de Matemática e Estatística
- 4Fundação Oswaldo Cruz, Instituto Oswaldo Cruz, Laboratório de Referência Nacional para Leptospirose/Laboratório de Zoonoses Bacterianas
- 5Ministério da Saúde do Brasil, Secretaria de Vigilância em Saúde de Ambiente
- 6Instituto Adolfo Lutz, Centro de Bacteriologia
- 7Fundação Ezequiel Dias, Instituto Otávio Magalhães
- 8Instituto Evandro Chagas, Seção de Bacteriologia e Micologia, Laboratório de Enteroinfecções Bacterianas
Abstract
Diagnosing leptospirosis and assessing test accuracy are challenging because no single method can reliably identify true infection across all stages, thereby preventing the establishment of a definitive gold standard. This study analyzes the performance of ELISA-IgM, DPP® Leptospirosis rapid test, and MAT using Latent Class Analysis (LCA) to infer infection status in the absence of an absolute reference standard. Samples from 430 individuals were included, whose diagnoses had been performed in reference laboratories in four states of Brazil. In the first stage of the analysis, 215 samples comprised the dataset used to estimate the two-latent-class model (“infected” and “not infected”). The latent status obtained was then used to estimate the accuracy of the tests in the second group of 215 individuals. ELISA-IgM, although highly sensitive (100%), showed low specificity (48.62%). MAT, in contrast, had high specificity (97.25%) but reduced sensitivity (69.81%). The DPP® Leptospirosis rapid test demonstrated a more balanced performance between sensitivity (82.08%) and specificity (90.83%). The results reinforce the need for combined diagnostic strategies to optimize leptospirosis detection, highlight the potential contribution of rapid testing in settings with limited laboratory infrastructure, and underscore the importance of improving the accuracy of currently available assays.
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BibTeX
@article{ribeiro2026diagnostic,
title = {{Diagnostic validity of ELISA-IgM, DPP® rapid test, and MAT for leptospirosis diagnosis in Brazilian reference laboratories: a latent class analysis}},
author = {Renata Aparecida Nascimento Ribeiro and Tiago Silveira Gontijo and Fabiano Borges Figueiredo and Heber Paulino Pena and Leila Denise Alves Ferreira Amorim and Michelle Pereira Vale dos Passos and Alexsandro Sobreira Galdino and Ana Alice Maia Gonçalves and Carolina Alves Petit Couto and Isadora Braga Gandra and Kátia Eliane Santos Avelar and Ilana Teruszkin Balassiano and Gilcelia Correia Santos Bernardes and Lidsy Ximenes Fonseca and Roberta Morozetti Blanco and Max Assunção Correia and Cintya de Oliveira Souza and Elaine Santos Lima and Vinícius Silva Belo},
journal = {Scientific Reports},
year = {2026},
month = jul,
doi = {10.1038/s41598-026-63621-w},
url = {https://doi.org/10.1038/s41598-026-63621-w},
note = {CC BY},
}
RIS
TY - JOUR
TI - Diagnostic validity of ELISA-IgM, DPP® rapid test, and MAT for leptospirosis diagnosis in Brazilian reference laboratories: a latent class analysis
AU - Renata Aparecida Nascimento Ribeiro
AU - Tiago Silveira Gontijo
AU - Fabiano Borges Figueiredo
AU - Heber Paulino Pena
AU - Leila Denise Alves Ferreira Amorim
AU - Michelle Pereira Vale dos Passos
AU - Alexsandro Sobreira Galdino
AU - Ana Alice Maia Gonçalves
AU - Carolina Alves Petit Couto
AU - Isadora Braga Gandra
AU - Kátia Eliane Santos Avelar
AU - Ilana Teruszkin Balassiano
AU - Gilcelia Correia Santos Bernardes
AU - Lidsy Ximenes Fonseca
AU - Roberta Morozetti Blanco
AU - Max Assunção Correia
AU - Cintya de Oliveira Souza
AU - Elaine Santos Lima
AU - Vinícius Silva Belo
PY - 2026
DA - 2026/07/01
JO - Scientific Reports
DO - 10.1038/s41598-026-63621-w
UR - https://doi.org/10.1038/s41598-026-63621-w
AB - Diagnosing leptospirosis and assessing test accuracy are challenging because no single method can reliably identify true infection across all stages, thereby preventing the establishment of a definitive gold standard. This study analyzes the performance of ELISA-IgM, DPP® Leptospirosis rapid test, and MAT using Latent Class Analysis (LCA) to infer infection status in the absence of an absolute reference standard. Samples from 430 individuals were included, whose diagnoses had been performed in reference laboratories in four states of Brazil. In the first stage of the analysis, 215 samples comprised the dataset used to estimate the two-latent-class model (“infected” and “not infected”). The latent status obtained was then used to estimate the accuracy of the tests in the second group of 215 individuals. ELISA-IgM, although highly sensitive (100%), showed low specificity (48.62%). MAT, in contrast, had high specificity (97.25%) but reduced sensitivity (69.81%). The DPP® Leptospirosis rapid test demonstrated a more balanced performance between sensitivity (82.08%) and specificity (90.83%). The results reinforce the need for combined diagnostic strategies to optimize leptospirosis detection, highlight the potential contribution of rapid testing in settings with limited laboratory infrastructure, and underscore the importance of improving the accuracy of currently available assays.
SN - 2045-2322
ER -