Urine-based ELISA using a recombinant chimeric protein for the diagnosis of paucibacillary and multibacillary leprosy

IF 2.8 3区医学 Q3 IMMUNOLOGY

Tuberculosis Pub Date : 2025-02-06 DOI:10.1016/j.tube.2025.102613

Raquel S.B. Câmara , Isabela A.G. Pereira , Geise C. Espíndola , Daniela P. Lage , Ana L. Silva , Camila S. Freitas , Bárbara P.N. Assis , Laís V.A. Corrêa , Ricardo L.F. Moreira , Sandra Lyon , Rozana C. Silva , Tiago S. Barros , Ana Laura G. de Oliveira , Fernanda Ludolf , Miguel A. Chávez-Fumagalli , Myron Christodoulides , Ricardo A. Machado-de-Ávila , Unaí Tupinambás , Denise U. Gonçalves , Manoel O. da Costa Rocha , Ana T. Chaves

{"title":"Urine-based ELISA using a recombinant chimeric protein for the diagnosis of paucibacillary and multibacillary leprosy","authors":"Raquel S.B. Câmara , Isabela A.G. Pereira , Geise C. Espíndola , Daniela P. Lage , Ana L. Silva , Camila S. Freitas , Bárbara P.N. Assis , Laís V.A. Corrêa , Ricardo L.F. Moreira , Sandra Lyon , Rozana C. Silva , Tiago S. Barros , Ana Laura G. de Oliveira , Fernanda Ludolf , Miguel A. Chávez-Fumagalli , Myron Christodoulides , Ricardo A. Machado-de-Ávila , Unaí Tupinambás , Denise U. Gonçalves , Manoel O. da Costa Rocha , Ana T. Chaves","doi":"10.1016/j.tube.2025.102613","DOIUrl":null,"url":null,"abstract":"<div><div>Leprosy diagnosis is difficult to perform due to variable sensitivity and/or specificity of the tests. In addition, the collection of the blood samples requires laboratorial structure and trained professionals. In the present study, the diagnostic efficacy of M1 chimeric protein, which was recently showed to be antigenic for leprosy using a serum-based ELISA, was evaluated against patient urine. Paired serum and urine samples were collected from patients with paucibacillary (PB) and multibacillary (MB) leprosy, tegumentary and visceral leishmaniasis, tuberculosis, Chagas disease, malaria, and HIV-infected subjects. Samples from healthy individuals and household contacts were also used. The protein and peptides used to compose it were used as antigens, and results showed that the four peptides presented good sensitivity and specificity to detect MB leprosy, while M1 protein showed sensitivity and specificity of 98.5 % and 100 %, respectively, to detect both PB and MB leprosy, when an urine-based ELISA was performed. Positive (PPV) and negative (NPV) predictive values were 100 % and 98.3 %, respectively. In a serum-based ELISA, sensitivity and specificity were 96.9 % and 100 %, respectively, with PPV and NPV of 100 % and 96.5 %, respectively. In conclusion, preliminary data suggest that M1 protein could be considered for diagnosis of leprosy by using patient urine.</div></div>","PeriodicalId":23383,"journal":{"name":"Tuberculosis","volume":"151 ","pages":"Article 102613"},"PeriodicalIF":2.8000,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tuberculosis","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1472979225000083","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Leprosy diagnosis is difficult to perform due to variable sensitivity and/or specificity of the tests. In addition, the collection of the blood samples requires laboratorial structure and trained professionals. In the present study, the diagnostic efficacy of M1 chimeric protein, which was recently showed to be antigenic for leprosy using a serum-based ELISA, was evaluated against patient urine. Paired serum and urine samples were collected from patients with paucibacillary (PB) and multibacillary (MB) leprosy, tegumentary and visceral leishmaniasis, tuberculosis, Chagas disease, malaria, and HIV-infected subjects. Samples from healthy individuals and household contacts were also used. The protein and peptides used to compose it were used as antigens, and results showed that the four peptides presented good sensitivity and specificity to detect MB leprosy, while M1 protein showed sensitivity and specificity of 98.5 % and 100 %, respectively, to detect both PB and MB leprosy, when an urine-based ELISA was performed. Positive (PPV) and negative (NPV) predictive values were 100 % and 98.3 %, respectively. In a serum-based ELISA, sensitivity and specificity were 96.9 % and 100 %, respectively, with PPV and NPV of 100 % and 96.5 %, respectively. In conclusion, preliminary data suggest that M1 protein could be considered for diagnosis of leprosy by using patient urine.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Tuberculosis 医学-呼吸系统

CiteScore

4.60

自引率

3.10%

发文量

审稿时长

49 days

期刊介绍： Tuberculosis is a speciality journal focusing on basic experimental research on tuberculosis, notably on bacteriological, immunological and pathogenesis aspects of the disease. The journal publishes original research and reviews on the host response and immunology of tuberculosis and the molecular biology, genetics and physiology of the organism, however discourages submissions with a meta-analytical focus (for example, articles based on searches of published articles in public electronic databases, especially where there is lack of evidence of the personal involvement of authors in the generation of such material). We do not publish Clinical Case-Studies. Areas on which submissions are welcomed include: -Clinical TrialsDiagnostics- Antimicrobial resistance- Immunology- Leprosy- Microbiology, including microbial physiology- Molecular epidemiology- Non-tuberculous Mycobacteria- Pathogenesis- Pathology- Vaccine development. This Journal does not accept case-reports. The resurgence of interest in tuberculosis has accelerated the pace of relevant research and Tuberculosis has grown with it, as the only journal dedicated to experimental biomedical research in tuberculosis.