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

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorFUJIMORI, Mahyumi
dc.contributor.authorVALENCIA-PORTILLO, Ruth Tamara
dc.contributor.authorLINDOSO, Jose Angelo Lauletta
dc.contributor.authorCELESTE, Beatriz Julieta
dc.contributor.authorALMEIDA, Roque Pacheco de
dc.contributor.authorCOSTA, Carlos Henrique Nery
dc.contributor.authorCRUZ, Alda Maria da
dc.contributor.authorDRUZIAN, Angelita Fernandes
dc.contributor.authorDUTHIE, Malcolm Scott
dc.contributor.authorFORTALEZA, Carlos Magno Castelo Branco
dc.contributor.authorOLIVEIRA, Ana Lucia Lyrio de
dc.contributor.authorPANIAGO, Anamaria Mello C. Miranda
dc.contributor.authorQUEIROZ, Igor Thiago
dc.contributor.authorREED, Steve
dc.contributor.authorVALLUR, Aarthy
dc.contributor.authorGOTO, Hiro
dc.contributor.authorSANCHEZ, Maria Carmen Arroyo
dc.date.accessioned2023-06-21T14:14:52Z
dc.date.available2023-06-21T14:14:52Z
dc.date.issued2023
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.eng
dc.description.indexMEDLINE
dc.description.indexPubMed
dc.description.indexWoS
dc.description.indexScopus
dc.identifier.citationPLOS ONE, v.18, n.3, 2023
dc.identifier.doi10.1371/journal.pone.0282483
dc.identifier.issn1932-6203
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/54009
dc.language.isoeng
dc.publisherPUBLIC LIBRARY SCIENCEeng
dc.relation.ispartofPlos One
dc.rightsopenAccesseng
dc.rights.holderCopyright PUBLIC LIBRARY SCIENCEeng
dc.subject.otherdirect agglutination-testeng
dc.subject.othertestseng
dc.subject.otherinfantumeng
dc.subject.otherantigeneng
dc.subject.otherserodiagnosiseng
dc.subject.otherinfectioneng
dc.subject.otherantibodyeng
dc.subject.otherdonovanieng
dc.subject.otherrk39eng
dc.subject.wosMultidisciplinary Scienceseng
dc.titleRecombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americaseng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.author.externalALMEIDA, Roque Pacheco de:Univ Fed Sergipe, Hosp Univ, Dept Med Interna & Patol, EBSERH, Aracaju, SE, Brazil
hcfmusp.author.externalCOSTA, Carlos Henrique Nery:Univ Fed Piaui, Inst Natan Portella Doencas Tropicais, Teresina, PI, Brazil
hcfmusp.author.externalCRUZ, Alda Maria da:Fiocruz MS, Inst Oswaldo Cruz, Lab Interdisciplinar Pesquisas Med, Rio De Janeiro, RJ, Brazil
hcfmusp.author.externalDRUZIAN, Angelita Fernandes:Univ Fed Mato Grosso do Sul, Fac Med, Campo Grande, MS, Brazil
hcfmusp.author.externalDUTHIE, Malcolm Scott:HDT Bio, Seattle, WA USA
hcfmusp.author.externalFORTALEZA, Carlos Magno Castelo Branco:Univ Estadual Paulista, Dept Doencas Tropicais & Diagnost Imagem, Botucatu, SP, Brazil
hcfmusp.author.externalOLIVEIRA, Ana Lucia Lyrio de:Univ Fed Mato Grosso do Sul, Fac Med, Campo Grande, MS, Brazil
hcfmusp.author.externalPANIAGO, Anamaria Mello C. Miranda:Univ Fed Mato Grosso do Sul, Fac Med, Campo Grande, MS, Brazil
hcfmusp.author.externalQUEIROZ, Igor Thiago:Hosp Giselda Trigueiro, Secretaria Estadual Saude Publ, Natal, RN, Brazil
hcfmusp.author.externalREED, Steve:HDT Bio, Seattle, WA USA
hcfmusp.author.externalVALLUR, Aarthy:InBios Int Inc, Seattle, WA USA
hcfmusp.citation.scopus0
hcfmusp.contributor.author-fmusphcMAHYUMI FUJIMORI
hcfmusp.contributor.author-fmusphcRUTH TAMARA VALENCIA PORTILLO
hcfmusp.contributor.author-fmusphcJOSE ANGELO LAULETTA LINDOSO
hcfmusp.contributor.author-fmusphcBEATRIZ JULIETA CELESTE
hcfmusp.contributor.author-fmusphcHIRO GOTO
hcfmusp.contributor.author-fmusphcMARIA CARMEN ARROYO SANCHEZ
hcfmusp.description.issue3
hcfmusp.description.volume18
hcfmusp.origemWOS
hcfmusp.origem.pubmed36862710
hcfmusp.origem.scopus2-s2.0-85149331471
hcfmusp.origem.wosWOS:000943271500011
hcfmusp.publisher.citySAN FRANCISCOeng
hcfmusp.publisher.countryUSAeng
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