Diagnostic validity of ELISA-IgM, DPP® rapid test, and MAT for leptospirosis diagnosis in Brazilian reference laboratories: a latent class analysis
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.
Authors
- Héber Paulino Pena (ORCID: https://orcid.org/0000-0002-9122-6827)
- Michelle Pereira Vale dos Passos (ORCID: https://orcid.org/0000-0002-4387-2234)
- Tiago Silveira Gontijo (ORCID: https://orcid.org/0000-0003-2636-899X)
- Isadora Braga Gandra
- Leila Denise Alves Ferreira Amorim (ORCID: https://orcid.org/0000-0002-1112-2332)
- Gilcélia Correia Santos Bernardes (ORCID: https://orcid.org/0000-0002-2839-2443)
- Max Assunção Correia
- Ilana Teruszkin Balassiano (ORCID: https://orcid.org/0000-0001-8036-1081)
- Roberta Morozetti Blanco (ORCID: https://orcid.org/0000-0002-8853-6795)
- Lidsy Ximenes Fonseca (ORCID: https://orcid.org/0000-0002-0831-400X)
- Alexsandro Sobreira Galdino (ORCID: https://orcid.org/0000-0002-8890-3030)
- Cintya de Oliveira Souza (ORCID: https://orcid.org/0000-0002-5496-3713)
- Renata Aparecida Nascimento Ribeiro
- Elaine Santos Lima
- Vinícius Silva Belo (ORCID: https://orcid.org/0000-0003-0183-1175)
- Kátia Eliane Santos Avelar (ORCID: https://orcid.org/0000-0002-7883-9442)
- Fabiano Borges Figueiredo (ORCID: https://orcid.org/0000-0001-6861-0997)
- Ana Alice Maia Gonçalves (ORCID: https://orcid.org/0000-0002-3374-5418)
- Carolina Alves Petit Couto
Institutions
- Universidade Federal da Bahia (BR)
- Brazilian Institute of Geography and Statistics (BR)
- Instituto Adolfo Lutz (BR)
- Ezequiel Dias Foundation (BR)
- Federal University of São João del-Rei (BR)
- Secretaria da Saúde (BR)
- Instituto Evandro Chagas (BR)
- Ministério da Saúde (ST)
- Fundação Carlos Chagas (BR)
- Fundação Oswaldo Cruz (BR)
Publication Details
- Journal
- Scientific Reports
- Published
- 2026-07-23
- DOI
- https://doi.org/10.1038/s41598-026-63621-w
- Primary Topic
- Leptospirosis research and findings
- Type
- article
- Field-Weighted Citation Impact
- 0.00