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

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dc.contributor.authorFujimori, Mahyumi
dc.contributor.authorValencia-Portillo, Ruth Tamara
dc.contributor.authorLauletta Lindoso, José Angelo
dc.contributor.authorCeleste, Beatriz Julieta
dc.contributor.authorde Almeida, Roque Pacheco
dc.contributor.authorNery Costa, Carlos Henrique
dc.contributor.authorda Cruz, Alda Maria
dc.contributor.authorDruzian, Angelita Fernandes
dc.contributor.authorDuthie, Malcolm Scott
dc.contributor.authorBranco Fortaleza, Carlos Magno Castelo [UNESP]
dc.contributor.authorde Oliveira, Ana Lúcia Lyrio
dc.contributor.authorMiranda Paniago, Anamaria Mello
dc.contributor.authorQueiroz, Igor Thiago
dc.contributor.authorReed, Steve
dc.contributor.authorVallur, Aarthy C.
dc.contributor.authorGoto, Hiro
dc.contributor.authorArroyo Sanchez, Maria Carmen
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionSecretaria de Estado da Saúde
dc.contributor.institutionUniversidade Federal de Sergipe (UFS)
dc.contributor.institutionUniversidade Federal do Piauí
dc.contributor.institutionInstituto Oswaldo Cruz/FIOCRUZ
dc.contributor.institutionUniversidade Federal de Mato Grosso do Sul (UFMS)
dc.contributor.institutionHDT Bio
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionSecretaria Estadual da Saúde Pública
dc.contributor.institutionInBios International Inc
dc.date.accessioned2023-07-29T13:44:33Z
dc.date.available2023-07-29T13:44:33Z
dc.date.issued2023-03-01
dc.description.abstractIn 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.en
dc.description.affiliationInstituto de Medicina Tropical Faculdade de Medicina Universidade de São Paulo, São Paulo
dc.description.affiliationDepartamento de Doenças Infecciosas e Parasitárias Faculdade de Medicina Universidade de São Paulo, São Paulo
dc.description.affiliationInstituto de Infectologia Emílio Ribas Secretaria de Estado da Saúde, São Paulo
dc.description.affiliationDepartamento de Medicina Preventiva Faculdade de Medicina Universidade de São Paulo, São Paulo
dc.description.affiliationDepartamento de Medicina Interna e Patologia Hospital Universitário EBSERH Universidade Federal de Sergipe, Sergipe
dc.description.affiliationInstituto Natan Portella para Doenças Tropicais Universidade Federal do Piauí, Piauí
dc.description.affiliationLaboratório Interdisciplinar de Pesquisas Médicas Instituto Oswaldo Cruz/FIOCRUZ, Rio de Janeiro
dc.description.affiliationFaculdade de Medicina Universidade Federal de Mato Grosso do Sul, Mato Grosso do Sul
dc.description.affiliationHDT Bio
dc.description.affiliationDepartamento de Doenças Tropicais e Diagnóstico por Imagem Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu
dc.description.affiliationHospital Giselda Trigueiro Secretaria Estadual da Saúde Pública, Rio Grande do Norte
dc.description.affiliationInBios International Inc
dc.description.affiliationUnespDepartamento de Doenças Tropicais e Diagnóstico por Imagem Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu
dc.identifierhttp://dx.doi.org/10.1371/journal.pone.0282483
dc.identifier.citationPLoS ONE, v. 18, n. 3 March, 2023.
dc.identifier.doi10.1371/journal.pone.0282483
dc.identifier.issn1932-6203
dc.identifier.scopus2-s2.0-85149331471
dc.identifier.urihttp://hdl.handle.net/11449/248458
dc.language.isoeng
dc.relation.ispartofPLoS ONE
dc.sourceScopus
dc.titleRecombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americasen
dc.typeArtigo

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