Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas.

Autor: Fujimori M; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil., Valencia-Portillo RT; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil., Lindoso JAL; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil.; Instituto de Infectologia Emílio Ribas, Secretaria de Estado da Saúde, São Paulo, São Paulo, Brazil., Celeste BJ; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil.; Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil., de Almeida RP; Departamento de Medicina Interna e Patologia, Hospital Universitário/EBSERH, Universidade Federal de Sergipe, Aracaju, Sergipe, Brazil., Costa CHN; Instituto Natan Portella para Doenças Tropicais, Universidade Federal do Piauí, Teresina, Piauí, Brazil., da Cruz AM; Laboratório Interdisciplinar de Pesquisas Médicas, Instituto Oswaldo Cruz/FIOCRUZ, Rio de Janeiro, Rio de Janeiro, Brazil., Druzian AF; Faculdade de Medicina, Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil., Duthie MS; HDT Bio, Seattle, Washington, United States of America., Fortaleza CMCB; Departamento de Doenças Tropicais e Diagnóstico por Imagem, Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu, São Paulo, Brazil., Oliveira ALL; Faculdade de Medicina, Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil., Paniago AMM; Faculdade de Medicina, Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil., Queiroz IT; Hospital Giselda Trigueiro, Secretaria Estadual da Saúde Pública, Natal, Rio Grande do Norte, Brazil., Reed S; HDT Bio, Seattle, Washington, United States of America., Vallur AC; InBios International Inc, Seattle, Washington, United States of America., Goto H; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil.; Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil., Sanchez MCA; Instituto de Medicina Tropical, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil.; Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Mar 02; Vol. 18 (3), pp. e0282483. Date of Electronic Publication: 2023 Mar 02 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0282483
Abstrakt: In the Americas, visceral leishmaniasis (VL) is caused by the protozoan Leishmania infantum, leading to death if not promptly diagnosed and treated. In Brazil, the disease reaches all regions, and in 2020, 1,933 VL cases were reported with 9.5% lethality. Thus, an accurate diagnosis is essential to provide the appropriate treatment. Serological VL diagnosis is based mainly on immunochromatographic tests, but their performance may vary by location, and evaluation of diagnostic alternatives is necessary. In this study, we aimed to evaluate the performance of ELISA with the scantily studied recombinant antigens, K18 and KR95, comparing their performance with the already known rK28 and rK39. Sera from parasitologically confirmed symptomatic VL patients (n = 90) and healthy endemic controls (n = 90) were submitted to ELISA with rK18 and rKR95. Sensitivity (95% CI) was, respectively, 83.3% (74.2-89.7) and 95.6% (88.8-98.6), and specificity (95% CI) was 93.3% (85.9-97.2) and 97.8% (91.8-99.9). For validation of ELISA with the recombinant antigens, we included samples from 122 VL patients and 83 healthy controls collected in three regions in Brazil (Northeast, Southeast, and Midwest). When comparing the results obtained with the VL patients' samples, significantly lower sensitivity was obtained by rK18-ELISA (88.5%, 95% CI: 81.5-93.2) compared with rK28-ELISA (95.9%, 95% CI: 90.5-98.5), but the sensitivity was similar comparing rKR95-ELISA (95.1%, 95% CI: 89.5-98.0), rK28-ELISA (95.9%, 95% CI: 90.5-98.5), and rK39-ELISA (94.3%, 95% CI: 88.4-97.4). Analyzing the specificity, it was lowest with rK18-ELISA (62.7%, 95% CI: 51.9-72.3) with 83 healthy control samples. Conversely, higher and similar specificity was obtained by rKR95-ELISA (96.4%, 95% CI: 89.5-99.2), rK28-ELISA (95.2%, 95% CI: 87.9-98.5), and rK39-ELISA (95.2%, 95% CI: 87.9-98.5). There was no difference in sensitivity and specificity across localities. Cross-reactivity assessment, performed with sera of patients diagnosed with inflammatory disorders and other infectious diseases, was 34.2% with rK18-ELISA and 3.1% with rKR95-ELISA. Based on these data, we suggest using recombinant antigen KR95 in serological assays for VL diagnosis.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Fujimori 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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