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

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...

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Autores principales: Fujimori, Mahyumi, Valencia-Portillo, Ruth Tamara, Lindoso, José Angelo Lauletta, Celeste, Beatriz Julieta, de Almeida, Roque Pacheco, Costa, Carlos Henrique Nery, da Cruz, Alda Maria, Druzian, Angelita Fernandes, Duthie, Malcolm Scott, Fortaleza, Carlos Magno Castelo Branco, de Oliveira, Ana Lúcia Lyrio, Paniago, Anamaria Mello Miranda, Queiroz, Igor Thiago, Reed, Steve, Vallur, Aarthy C., Goto, Hiro, Sanchez, Maria Carmen Arroyo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9980733/
https://www.ncbi.nlm.nih.gov/pubmed/36862710
http://dx.doi.org/10.1371/journal.pone.0282483
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author Fujimori, Mahyumi
Valencia-Portillo, Ruth Tamara
Lindoso, José Angelo Lauletta
Celeste, Beatriz Julieta
de Almeida, Roque Pacheco
Costa, Carlos Henrique Nery
da Cruz, Alda Maria
Druzian, Angelita Fernandes
Duthie, Malcolm Scott
Fortaleza, Carlos Magno Castelo Branco
de Oliveira, Ana Lúcia Lyrio
Paniago, Anamaria Mello Miranda
Queiroz, Igor Thiago
Reed, Steve
Vallur, Aarthy C.
Goto, Hiro
Sanchez, Maria Carmen Arroyo
author_facet Fujimori, Mahyumi
Valencia-Portillo, Ruth Tamara
Lindoso, José Angelo Lauletta
Celeste, Beatriz Julieta
de Almeida, Roque Pacheco
Costa, Carlos Henrique Nery
da Cruz, Alda Maria
Druzian, Angelita Fernandes
Duthie, Malcolm Scott
Fortaleza, Carlos Magno Castelo Branco
de Oliveira, Ana Lúcia Lyrio
Paniago, Anamaria Mello Miranda
Queiroz, Igor Thiago
Reed, Steve
Vallur, Aarthy C.
Goto, Hiro
Sanchez, Maria Carmen Arroyo
author_sort Fujimori, Mahyumi
collection PubMed
description 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. 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.
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spelling pubmed-99807332023-03-03 Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas Fujimori, Mahyumi Valencia-Portillo, Ruth Tamara Lindoso, José Angelo Lauletta Celeste, Beatriz Julieta de Almeida, Roque Pacheco Costa, Carlos Henrique Nery da Cruz, Alda Maria Druzian, Angelita Fernandes Duthie, Malcolm Scott Fortaleza, Carlos Magno Castelo Branco de Oliveira, Ana Lúcia Lyrio Paniago, Anamaria Mello Miranda Queiroz, Igor Thiago Reed, Steve Vallur, Aarthy C. Goto, Hiro Sanchez, Maria Carmen Arroyo PLoS One Research Article 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. 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. Public Library of Science 2023-03-02 /pmc/articles/PMC9980733/ /pubmed/36862710 http://dx.doi.org/10.1371/journal.pone.0282483 Text en © 2023 Fujimori et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Fujimori, Mahyumi
Valencia-Portillo, Ruth Tamara
Lindoso, José Angelo Lauletta
Celeste, Beatriz Julieta
de Almeida, Roque Pacheco
Costa, Carlos Henrique Nery
da Cruz, Alda Maria
Druzian, Angelita Fernandes
Duthie, Malcolm Scott
Fortaleza, Carlos Magno Castelo Branco
de Oliveira, Ana Lúcia Lyrio
Paniago, Anamaria Mello Miranda
Queiroz, Igor Thiago
Reed, Steve
Vallur, Aarthy C.
Goto, Hiro
Sanchez, Maria Carmen Arroyo
Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title_full Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title_fullStr Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title_full_unstemmed Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title_short Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas
title_sort recombinant protein kr95 as an alternative for serological diagnosis of human visceral leishmaniasis in the americas
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9980733/
https://www.ncbi.nlm.nih.gov/pubmed/36862710
http://dx.doi.org/10.1371/journal.pone.0282483
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