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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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2023
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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. |
format | Online Article Text |
id | pubmed-9980733 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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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