ELISA with recombinant antigen Lb6H validated for the diagnosis of American tegumentary leishmaniasis.

Autor: Valencia-Portillo RT; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Soroepidemiologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil., Lindoso JA; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Soroepidemiologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Instituto de Infectologia Emílio Ribas, Secretaria de Saúde do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Protozoologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil., Celeste BJ; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Soroepidemiologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Faculdade de Medicina, Departamento de Medicina Preventiva, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil., Bittencourt AA; Instituto de Infectologia Emílio Ribas, Secretaria de Saúde do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Global Medical Affairs, MSD in Brazil, Sao Paulo, São Paulo, Brazil., de Brito MEF; Centro de Pesquisas Aggeu Magalhães, Fundacao Oswaldo Cruz, Recife, Pernambuco, Brazil., Duthie MS; Host Directed Therapeutics, Seattle, Washington, United States of America., Guderian J; Access to Advanced Health Institute, Seattle, Washington, United States of America., Guerra J; Fundacao de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Amazonas, Brazil., Oliveira ALL; Faculdade de Medicina, Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil., Reed S; Host Directed Therapeutics, Seattle, Washington, United States of America., Rocha MC; Laboratório de Investigação Médica (LIM 48), Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil., Santos NT; Fundacao de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Amazonas, Brazil., Silveira FT; Departamento de Parasitologia, Instituto Evandro Chagas, Pará, Pará, Brazil.; Núcleo de Medicina Tropical, Universidade Federal de Para, Pará, Brazil., Goto H; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Soroepidemiologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Faculdade de Medicina, Departamento de Medicina Preventiva, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil., Sanchez MCA; Faculdade de Medicina, Instituto de Medicina Tropical de Sao Paulo, Laboratório de Soroepidemiologia, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.; Faculdade de Medicina, Departamento de Medicina Preventiva, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2024 Jun 05; Vol. 19 (6), pp. e0304268. Date of Electronic Publication: 2024 Jun 05 (Print Publication: 2024).
DOI: 10.1371/journal.pone.0304268
Abstrakt: American tegumentary leishmaniasis (ATL) diagnosis is an open question, and the search for a solution is urgent. The available tests that detect the etiological agent of the infection are specific for ATL diagnosis. However, they present disadvantages, such as low sensitivity and the need for invasive procedures to obtain the samples. Immunological methods (leishmanin skin test and search for anti-Leishmania antibodies) are good alternatives to the etiological diagnosis of ATL. Presently, we face problems with disease confirmation due to the discontinuity in the production of leishmanin skin test antigen, particularly in resource-poor settings. Aiming to diagnose ATL, we validated rLb6H-ELISA for IgG antibodies using 1,091 samples from leishmaniasis patients and healthy controls, divided into four panels, living in 19 Brazilian endemic and non-endemic states. The rLb6H-ELISA showed a sensitivity of 98.6% and a specificity of 100.0%, with the reference panel comprising 70 ATL patient samples and 70 healthy controls. The reproducibility evaluation showed a coefficient of variation of positive samples ≤ 8.20% for repeatability, ≤ 17,97% for reproducibility, and ≤ 8.12% for homogeneity. The plates sensitized with rLb6H were stable at 4°C and -20°C for 180 days and 37°C for seven days, indicating 12 months of validity. In samples of ATL patients from five research and healthcare centers in endemic and non-endemic areas, rLb6H-ELISA showed a sensitivity of 84.0%; no significant statistical difference was observed among the five centers (chi-square test, p = 0.13). In samples of healthy controls from four areas with different endemicity, a specificity of 92.4% was obtained; lower specificity was obtained in a visceral leishmaniasis high endemicity locality (chi-square test, p<0.001). Cross-reactivity was assessed in 166 other disease samples with a positivity of 13.9%. Based on the good diagnostic performance and the reproducibility and stability of the antigen, we suggest using ELISA-rLb6H to diagnose ATL.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Valencia-Portillo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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