Back to Search Start Over

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

Authors :
Mahyumi Fujimori
Ruth Tamara Valencia-Portillo
José Angelo Lauletta Lindoso
Beatriz Julieta Celeste
Roque Pacheco de Almeida
Carlos Henrique Nery Costa
Alda Maria da Cruz
Angelita Fernandes Druzian
Malcolm Scott Duthie
Carlos Magno Castelo Branco Fortaleza
Ana Lúcia Lyrio de Oliveira
Anamaria Mello Miranda Paniago
Igor Thiago Queiroz
Steve Reed
Aarthy C. Vallur
Hiro Goto
Maria Carmen Arroyo Sanchez
Source :
PLoS ONE, Vol 18, Iss 3 (2023)
Publication Year :
2023
Publisher :
Public Library of Science (PLoS), 2023.

Abstract

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.

Subjects

Subjects :
Medicine
Science

Details

Language :
English
ISSN :
19326203
Volume :
18
Issue :
3
Database :
Directory of Open Access Journals
Journal :
PLoS ONE
Publication Type :
Academic Journal
Accession number :
edsdoj.4b3fd3df8e74437a40ed72b0ebc3ec4
Document Type :
article