Author | Fujimori, Mahyumi | |
Author | Valencia-Portillo, Ruth Tamara | |
Author | Lindoso, Jose´ Angelo Lauletta | |
Author | Celeste, Beatriz Julieta | |
Author | Almeida, Roque Pacheco de | |
Author | Costa, Carlos Henrique Nery | |
Author | Cruz, Alda Maria da | |
Author | Druzian, Angelita Fernandes | |
Author | Duthie, Malcolm Scott | |
Author | Fortaleza, Carlos Magno Castelo Branco | |
Author | Oliveira, Ana Lúcia Lyrio de | |
Author | Paniago, Anamaria Mello Miranda | |
Author | Queiroz, Igor Thiago | |
Author | Reed, Steve | |
Author | Vallur, Aarthy C. | |
Author | Goto, Hiro | |
Author | Sanchez, Maria Carmen Arroyo | |
Access date | 2023-05-08T18:35:41Z | |
Available date | 2023-05-08T18:35:41Z | |
Document date | 2023 | |
Citation | FUJIMORI, Mahyumi et al. Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas. Plos One, v. 18, n. 3, e0282483, Mar. 2023. | en_US |
ISSN | 1932-6203 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/58210 | |
Abstract in Portuguese | 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. Crossreactivity
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_US |
Language | eng | en_US |
Publisher | Public Library of Science | en_US |
Rights | open access | |
Subject in Portuguese | Proteína recombinante KR95 | en_US |
Subject in Portuguese | Como alternativa para o diagnóstico sorológico | en_US |
Subject in Portuguese | Infecção visceral humana leishmaniose | en_US |
Subject in Portuguese | Nas Américas | en_US |
Title | Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas | en_US |
Type | Article | |
DOI | 10.1371/journal. pone.0282483 | |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brasil. | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brasil. | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Departamento de Doenças Infecciosas e Parasitárias. São Paulo, SP, Brasil / Secretaria de Estado da Saúde, São Paulo / Instituto de Infectologia Emílio Ribas. São Paulo, SP, Brasil. | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brasil / Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil. | en_US |
Affilliation | Universidade Federal de Sergipe. Hospital Universitário/EBSERH. Departamento de Medicina Interna e Patologia. Aracaju, SE, Brasil. | en_US |
Affilliation | Universidade Federal do Piauí. Instituto Natan Portella para Doenc¸as Tropicais. Aracaju, Sergipe, Brasil. | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório Interdisciplinar de Pesquisas Médicas. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Universidade Federal de Mato Grosso do Sul. Faculdade de Medicina. Campo Grande, MS, Brasil. | en_US |
Affilliation | HDT Bio, Seattle, Washington, United States of America. | en_US |
Affilliation | Universidade Estadual Paulista Júlio de Mesquita Filho. Departamento de Doenças Tropicais e Diagnóstico por Imagem. Botucatu, SP, Brasil. | en_US |
Affilliation | Universidade Federal de Mato Grosso do Sul. Faculdade de Medicina. Campo Grande, MS, Brasil. | en_US |
Affilliation | Universidade Federal de Mato Grosso do Sul. Faculdade de Medicina. Campo Grande, MS, Brasil. | en_US |
Affilliation | Hospital Giselda Trigueiro. Secretaria Estadual da Saúde Pública, Natal, RN, Brasil. | en_US |
Affilliation | HDT Bio, Seattle, Washington, United States of America. | en_US |
Affilliation | InBios International Inc, Seattle, Washington, United States of America. | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brasil / Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.. | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brasil / Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil. | en_US |
Subject | Recombinant protein KR95 | en_US |
Subject | Alternative for serological diagnosis | en_US |
Subject | Human visceral leishmaniasis | en_US |
Subject | Americas | en_US |