{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T11:50:21Z","timestamp":1767181821820,"version":"build-2238731810"},"reference-count":42,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T00:00:00Z","timestamp":1677715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011721","name":"Laborat\u00f3rios de Investiga\u00e7\u00e3o M\u00e9dica - Hospital das Cl\u00ednicas da Faculdade de Medicina da Universidade de S\u00e3o Paulo","doi-asserted-by":"publisher","award":["LIM 38"],"award-info":[{"award-number":["LIM 38"]}],"id":[{"id":"10.13039\/501100011721","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","doi-asserted-by":"publisher","award":["302940\/2019-7"],"award-info":[{"award-number":["302940\/2019-7"]}],"id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001807","name":"Funda\u00e7\u00e3o de Amparo \u00e0 Pesquisa do Estado de S\u00e3o Paulo","doi-asserted-by":"publisher","award":["2017\/03367-3"],"award-info":[{"award-number":["2017\/03367-3"]}],"id":[{"id":"10.13039\/501100001807","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002322","name":"Coordena\u00e7\u00e3o de Aperfei\u00e7oamento de Pessoal de N\u00edvel Superior","doi-asserted-by":"publisher","award":["88882.376665\/2019-01 and 88887.689454\/2022-00"],"award-info":[{"award-number":["88882.376665\/2019-01 and 88887.689454\/2022-00"]}],"id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>\n                    In the Americas, visceral leishmaniasis (VL) is caused by the protozoan\n                    <jats:italic>Leishmania infantum<\/jats:italic>\n                    , 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\u201389.7) and 95.6% (88.8\u201398.6), and specificity (95% CI) was 93.3% (85.9\u201397.2) and 97.8% (91.8\u201399.9). 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\u2019 samples, significantly lower sensitivity was obtained by rK18-ELISA (88.5%, 95% CI: 81.5\u201393.2) compared with rK28-ELISA (95.9%, 95% CI: 90.5\u201398.5), but the sensitivity was similar comparing rKR95-ELISA (95.1%, 95% CI: 89.5\u201398.0), rK28-ELISA (95.9%, 95% CI: 90.5\u201398.5), and rK39-ELISA (94.3%, 95% CI: 88.4\u201397.4). Analyzing the specificity, it was lowest with rK18-ELISA (62.7%, 95% CI: 51.9\u201372.3) with 83 healthy control samples. Conversely, higher and similar specificity was obtained by rKR95-ELISA (96.4%, 95% CI: 89.5\u201399.2), rK28-ELISA (95.2%, 95% CI: 87.9\u201398.5), and rK39-ELISA (95.2%, 95% CI: 87.9\u201398.5). 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.\n                  <\/jats:p>","DOI":"10.1371\/journal.pone.0282483","type":"journal-article","created":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T13:36:43Z","timestamp":1677764203000},"page":"e0282483","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas"],"prefix":"10.1371","volume":"18","author":[{"given":"Mahyumi","family":"Fujimori","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3552-8318","authenticated-orcid":true,"given":"Ruth Tamara","family":"Valencia-Portillo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos\u00e9 Angelo Lauletta","family":"Lindoso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatriz Julieta","family":"Celeste","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roque Pacheco","family":"de Almeida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos Henrique Nery","family":"Costa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7455-2447","authenticated-orcid":true,"given":"Alda Maria","family":"da Cruz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelita Fernandes","family":"Druzian","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malcolm Scott","family":"Duthie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos Magno Castelo Branco","family":"Fortaleza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana L\u00facia Lyrio de","family":"Oliveira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anamaria Mello Miranda","family":"Paniago","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2346-0272","authenticated-orcid":true,"given":"Igor Thiago","family":"Queiroz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steve","family":"Reed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aarthy C.","family":"Vallur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiro","family":"Goto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4055-5556","authenticated-orcid":true,"given":"Maria Carmen Arroyo","family":"Sanchez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,3,2]]},"reference":[{"key":"pone.0282483.ref001","unstructured":"CDC\u2014DPDx Laboratory Identification of Parasites of Public Health Concern. 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Brasil, Grandes Regi\u00f5es e Unidades Federadas. 2000 a 2020. 2021 [cited 5 Oct 2022]. https:\/\/www.gov.br\/saude\/pt-br\/assuntos\/saude-de-a-a-z\/l\/leishmaniose-visceral\/arquivos\/lv-letalidade.pdf"},{"key":"pone.0282483.ref006","unstructured":"Sinan\/SVS\/MS. Casos confirmados de leishmaniose visceral, Brasil, Grandes Regi\u00f5es e Unidades Federadas. 1990 a 2020. 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