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

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Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorSecretaria de Estado da Saúde-
Autor(es): dc.contributorUniversidade Federal de Sergipe (UFS)-
Autor(es): dc.contributorUniversidade Federal do Piauí-
Autor(es): dc.contributorInstituto Oswaldo Cruz/FIOCRUZ-
Autor(es): dc.contributorUniversidade Federal de Mato Grosso do Sul (UFMS)-
Autor(es): dc.contributorHDT Bio-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorSecretaria Estadual da Saúde Pública-
Autor(es): dc.contributorInBios International Inc-
Autor(es): dc.creatorFujimori, Mahyumi-
Autor(es): dc.creatorValencia-Portillo, Ruth Tamara-
Autor(es): dc.creatorLauletta Lindoso, José Angelo-
Autor(es): dc.creatorCeleste, Beatriz Julieta-
Autor(es): dc.creatorde Almeida, Roque Pacheco-
Autor(es): dc.creatorNery Costa, Carlos Henrique-
Autor(es): dc.creatorda Cruz, Alda Maria-
Autor(es): dc.creatorDruzian, Angelita Fernandes-
Autor(es): dc.creatorDuthie, Malcolm Scott-
Autor(es): dc.creatorBranco Fortaleza, Carlos Magno Castelo-
Autor(es): dc.creatorde Oliveira, Ana Lúcia Lyrio-
Autor(es): dc.creatorMiranda Paniago, Anamaria Mello-
Autor(es): dc.creatorQueiroz, Igor Thiago-
Autor(es): dc.creatorReed, Steve-
Autor(es): dc.creatorVallur, Aarthy C.-
Autor(es): dc.creatorGoto, Hiro-
Autor(es): dc.creatorArroyo Sanchez, Maria Carmen-
Data de aceite: dc.date.accessioned2025-08-21T18:55:59Z-
Data de disponibilização: dc.date.available2025-08-21T18:55:59Z-
Data de envio: dc.date.issued2023-07-29-
Data de envio: dc.date.issued2023-07-29-
Data de envio: dc.date.issued2023-03-01-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1371/journal.pone.0282483-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/248458-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/248458-
Descrição: dc.descriptionIn 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.-
Descrição: dc.descriptionInstituto de Medicina Tropical Faculdade de Medicina Universidade de São Paulo, São Paulo-
Descrição: dc.descriptionDepartamento de Doenças Infecciosas e Parasitárias Faculdade de Medicina Universidade de São Paulo, São Paulo-
Descrição: dc.descriptionInstituto de Infectologia Emílio Ribas Secretaria de Estado da Saúde, São Paulo-
Descrição: dc.descriptionDepartamento de Medicina Preventiva Faculdade de Medicina Universidade de São Paulo, São Paulo-
Descrição: dc.descriptionDepartamento de Medicina Interna e Patologia Hospital Universitário EBSERH Universidade Federal de Sergipe, Sergipe-
Descrição: dc.descriptionInstituto Natan Portella para Doenças Tropicais Universidade Federal do Piauí, Piauí-
Descrição: dc.descriptionLaboratório Interdisciplinar de Pesquisas Médicas Instituto Oswaldo Cruz/FIOCRUZ, Rio de Janeiro-
Descrição: dc.descriptionFaculdade de Medicina Universidade Federal de Mato Grosso do Sul, Mato Grosso do Sul-
Descrição: dc.descriptionHDT Bio-
Descrição: dc.descriptionDepartamento de Doenças Tropicais e Diagnóstico por Imagem Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu-
Descrição: dc.descriptionHospital Giselda Trigueiro Secretaria Estadual da Saúde Pública, Rio Grande do Norte-
Descrição: dc.descriptionInBios International Inc-
Descrição: dc.descriptionDepartamento de Doenças Tropicais e Diagnóstico por Imagem Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu-
Idioma: dc.languageen-
Relação: dc.relationPLoS ONE-
???dc.source???: dc.sourceScopus-
Título: dc.titleRecombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas-
Tipo de arquivo: dc.typelivro digital-
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