{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T05:36:29Z","timestamp":1780378589077,"version":"3.54.1"},"reference-count":37,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2022,8,9]],"date-time":"2022-08-09T00:00:00Z","timestamp":1660003200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Ministry of Health"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>Background: Leprosy is a neglected tropical disease caused by Mycobacterium leprae, leading to disabilities if untreated. The ELISA based on phenolic glycolipid I (PGL-I), or its synthetic version ND-O-BSA, is almost universally positive in multibacillary leprosy and thus extensively used in endemic countries. Household contacts with a positive antibody titer have ~6-fold higher probability to develop the disease than those with a negative titer. Thus, the aim of the study was to evaluate the performance of this ELISA in the setting of a non-endemic country. Methods: We calculate the cut-off using optimized O.D. thresholds, generated by receiver operating characteristics (ROC) curve analysis, testing 39 well-characterized sera obtained from lepromatous leprosy patients with strongly positive ND-O-BSAELISA titer and 39 sera from healthy non-endemic patients never exposed to M. leprae or M. tuberculosis. Indeed, we tested a second set of sera from suspected or confirmed leprosy or household contacts (SLALT group, n=50), and patients with tuberculosis (control group, n=40). Results: We detected 56.4% of SLALT and 22.5% of tuberculosis as positive, consistent with the literature. Conclusion: The ELISA based on ND-O-BSA may thus be considered a good option to be used in a non-endemic area as a screening tool in at risk population usually coming to our center.<\/jats:p>","DOI":"10.3390\/pathogens11080894","type":"journal-article","created":{"date-parts":[[2022,8,10]],"date-time":"2022-08-10T04:20:32Z","timestamp":1660105232000},"page":"894","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["ELISA Test Based on the Phenolic Glycolipid-I (PGL-I) of Mycobacterium leprae: A Reality of a Laboratory from a Non-Endemic Country"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2447-1777","authenticated-orcid":false,"given":"Silvia Stefania","family":"Longoni","sequence":"first","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Beltrame","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Prato","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Stewart","family":"Spencer","sequence":"additional","affiliation":[{"name":"Mycobacteria Research Laboratories, Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO 80523, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolo","family":"Bergamaschi","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Clapasson","sequence":"additional","affiliation":[{"name":"Dermatological Clinic, National Reference Center for Hansen\u2019s Disease, IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurora","family":"Parodi","sequence":"additional","affiliation":[{"name":"Dermatological Clinic, National Reference Center for Hansen\u2019s Disease, IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"},{"name":"Department of Health Science (DISSAL), University of Genova, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5739-3795","authenticated-orcid":false,"given":"Chiara","family":"Piubelli","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Perandin","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,8,9]]},"reference":[{"key":"ref_1","unstructured":"(2021, September 14). WHO Leprosy: Situation and Trends. Available online: https:\/\/apps.who.int\/neglected_diseases\/ntddata\/leprosy\/leprosy.html."},{"key":"ref_2","unstructured":"WHO (2016). Global Leprosy Strategy 2016\u20132020, World Health Organization, Regional Office for South-East Asia."},{"key":"ref_3","unstructured":"(2021, April 30). WHO Leprosy-Key Facts. Available online: http:\/\/www.who.int\/mediacentre\/factsheets\/fs101\/en\/."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"999","DOI":"10.1111\/j.1468-3083.2011.04201.x","article-title":"Imported leprosy in Italy","volume":"26","author":"Massone","year":"2012","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"8868","DOI":"10.1038\/s41598-017-07803-7","article-title":"Field-friendly serological tests for determination of M. leprae-specific antibodies","volume":"7","author":"Wilson","year":"2017","journal-title":"Sci. Rep."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"da Silva, M.B., Li, W., Bouth, R.C., Gobbo, A.R., Messias, A.C.C., Moraes, T.M.P., Jorge, E.V.O., Barreto, J.G., Filho, F.B., and Conde, G.A.B. (2021). Latent leprosy infection identified by dual RLEP and anti-PGL-I positivity: Implications for new control strategies. PLoS ONE, 16.","DOI":"10.1371\/journal.pone.0251631"},{"key":"ref_7","unstructured":"WHO (2018). Guidelines for the Diagnosis, Treatment and Prevention of Leprosy, World Health Organization, Regional Office for South-East Asia."},{"key":"ref_8","unstructured":"(2021, September 14). MSI (Ministero della Salute Italiano) Morbo di Hansen, Available online: http:\/\/www.salute.gov.it\/portale\/salute\/p1_5.jsp?lingua=italiano&id=203&area=Malattie_infettive."},{"key":"ref_9","unstructured":"(2021, September 14). WHO Diagnosis of Leprosy. Available online: https:\/\/www.who.int\/lep\/diagnosis\/en\/."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1096","DOI":"10.1086\/512809","article-title":"Methods for the Classification of Leprosy for Treatment Purposes","volume":"44","author":"Pardillo","year":"2007","journal-title":"Clin. Infect. Dis."},{"key":"ref_11","first-page":"255","article-title":"Classification of leprosy according to immunity. A five-group system","volume":"34","author":"Ridley","year":"1966","journal-title":"Int. J. Lepr. Other Mycobact. Dis."},{"key":"ref_12","unstructured":"Nunzi, E., and Massone, C. (2009). La lebbra in Italia. Note di Leprologia, Associazione Italiana Amici di Raoul Follerau (Aifo)."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Gillis, T.P. (2015). Mycobacterium Leprae. Molecular Medical Microbiology, Academic Press. [2nd ed.].","DOI":"10.1016\/B978-0-12-397169-2.00093-7"},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Tatipally, S., Srikantam, A., and Kasetty, S. (2018). Polymerase Chain Reaction (PCR) as a Potential Point of Care Laboratory Test for Leprosy Diagnosis\u2014A Systematic Review. Trop. Med. Infect. Dis., 3.","DOI":"10.3390\/tropicalmed3040107"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1016\/j.medmal.2015.09.002","article-title":"Update on the epidemiology, diagnosis, and treatment of leprosy","volume":"45","author":"Reibel","year":"2015","journal-title":"Med. Mal. Infect."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"23","DOI":"10.4103\/0378-6323.168935","article-title":"Viability of Mycobacterium leprae in the environment and its role in leprosy dissemination","volume":"82","author":"Mohanty","year":"2016","journal-title":"Indian J. Dermatol. Venereol. Leprol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"344","DOI":"10.47276\/lr.82.4.344","article-title":"The role of Mycobacterium leprae phenolic glycolipid I (PGL-I) in serodiagnosis and in the pathogenesis of leprosy","volume":"82","author":"Spencer","year":"2011","journal-title":"Lepr. Rev."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s40249-016-0203-0","article-title":"Can baseline ML Flow test results predict leprosy reactions? An investigation in a cohort of patients enrolled in the uniform multidrug therapy clinical trial for leprosy patients in Brazil","volume":"5","author":"Hungria","year":"2016","journal-title":"Infect. Dis. Poverty"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1128\/CVI.00372-07","article-title":"Risk and protective factors for leprosy development determined by epidemiological surveillance of household contacts","volume":"15","author":"Goulart","year":"2008","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"9828023","DOI":"10.1155\/2018\/9828023","article-title":"Accuracy of Enzyme-Linked Immunosorbent Assays (ELISAs) in Detecting Antibodies against Mycobacterium leprae in Leprosy Patients: A Systematic Review and Meta-Analysis","volume":"2018","author":"Espinosa","year":"2018","journal-title":"Can. J. Infect. Dis. Med. Microbiol."},{"key":"ref_21","first-page":"11","article-title":"Leprosy serology using PGL-I: A systematic review","volume":"41","author":"Calado","year":"2008","journal-title":"Rev. Soc. Bras. Med. Trop."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1128\/CVI.00472-10","article-title":"Analysis of antibody responses to Mycobacterium leprae phenolic glycolipid I, lipoarabinomannan, and recombinant proteins to define disease subtype-specific antigenic profiles in leprosy","volume":"18","author":"Spencer","year":"2011","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/j.mimet.2005.12.003","article-title":"Detection of Mycobacterium tuberculosis complex with Real Time PCR: Comparison of different primer-probe sets based on the IS6110 element","volume":"66","author":"Savelkoul","year":"2006","journal-title":"J. Microbiol. Methods"},{"key":"ref_24","first-page":"533","article-title":"Low predictive value of PGL-I serology for the early diagnosis of leprosy in family contacts: Results of a 10-year prospective field study in French polynesia","volume":"61","author":"Chanteau","year":"1993","journal-title":"Int. J. Lepr."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Paula Vaz Cardoso, L., Dias, R.F., Freitas, A.A., Hungria, E.M., Oliveira, R.M., Collovati, M., Reed, S.G., Duthie, M.S., and Martins Ara\u00fajo Stefani, M. (2013). Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology. BMC Infect. Dis., 13.","DOI":"10.1186\/1471-2334-13-497"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"389","DOI":"10.47276\/lr.82.4.389","article-title":"Comparison of three immunological tests for leprosy diagnosis and detection of subclinical infection","volume":"82","author":"Lobato","year":"2011","journal-title":"Lepr. Rev."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.diagmicrobio.2014.02.006","article-title":"A rapid ELISA for the diagnosis of MB leprosy based on complementary detection of antibodies against a novel protein-glycolipid conjugate","volume":"79","author":"Duthie","year":"2014","journal-title":"Diagn. Microbiol. Infect. Dis."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1371\/journal.pntd.0005375","article-title":"Unexpectedly high leprosy seroprevalence detected using a random surveillance strategy in midwestern Brazil: A comparison of ELISA and a rapid diagnostic test","volume":"11","author":"Frade","year":"2017","journal-title":"PLoS Negl. Trop. Dis."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s12879-018-3653-0","article-title":"Performance of serological tests PGL1 and NDO-LID in the diagnosis of leprosy in a reference Center in Brazil","volume":"19","author":"Leturiondo","year":"2019","journal-title":"BMC Infect. Dis."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1093\/trstmh\/trz089","article-title":"Evaluation of antibody detection against the NDO-BSA, LID-1 and NDO-LID antigens as confirmatory tests to support the diagnosis of leprosy in Yunnan province, southwest China","volume":"114","author":"Jian","year":"2020","journal-title":"Trans. R. Soc. Trop. Med. Hyg."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"18","DOI":"10.47276\/lr.74.1.18","article-title":"Comparison of PCR mediated amplification of DNA and the classical methods for detection of Mycobacterium leprae in different types of clinical samples in leprosy patients and contacts","volume":"74","author":"Torres","year":"2003","journal-title":"Lepr. Rev."},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Barbieri, R.R., Manta, F.S.N., Moreira, S.J.M., Sales, A.M., Nery, J.A.C., Nascimento, L.P.R., Hacker, M.A., Pacheco, A.G., Machado, A.M., and Sarno, E.M. (2019). Quantitative polymerase chain reaction in paucibacillary leprosy diagnosis: A follow-up study. PLoS Negl. Trop. Dis., 13.","DOI":"10.1371\/journal.pntd.0007147"},{"key":"ref_33","doi-asserted-by":"crossref","unstructured":"Gama, R.S., de Souza, M.L.M., Sarno, E.N., de Moraes, M.O., Gon\u00e7alves, A., Stefani, M.M.A., Garcia, R.M.G., and de Oliveira Fraga, L.A. (2019). A novel integrated molecular and serological analysis method to predict new cases of leprosy amongst household contacts. PLoS Negl. Trop. Dis., 13.","DOI":"10.1371\/journal.pntd.0007400"},{"key":"ref_34","first-page":"1","article-title":"Revisiting primary neural leprosy: Clinical, serological, molecular, and neurophysiological aspects","volume":"11","author":"Antunes","year":"2017","journal-title":"PLoS Negl. Trop. Dis."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1016\/j.healthpol.2020.12.010","article-title":"Health assessment for migrants and asylum seekers upon arrival and while hosted in reception centres: Italian guidelines","volume":"125","author":"Tosti","year":"2021","journal-title":"Health Policy"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"807","DOI":"10.25259\/IJDVL_622_19","article-title":"Semmes-Weinstein monofilament: A tool to quantify skin sensation in macular lesions for leprosy diagnosis","volume":"87","author":"Frade","year":"2021","journal-title":"Indian J. Dermatol. Venereol. Leprol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"166","DOI":"10.4103\/ijmy.ijmy_62_19","article-title":"Detection of Anti-Phenolic Glycolipid-I antibody in sera from tuberculosis patients in Bandung, West Java, Indonesia","volume":"8","author":"Gunawan","year":"2017","journal-title":"Int. J. Mycobacteriol."}],"container-title":["Pathogens"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-0817\/11\/8\/894\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T00:06:18Z","timestamp":1760141178000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-0817\/11\/8\/894"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,9]]},"references-count":37,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2022,8]]}},"alternative-id":["pathogens11080894"],"URL":"https:\/\/doi.org\/10.3390\/pathogens11080894","relation":{},"ISSN":["2076-0817"],"issn-type":[{"value":"2076-0817","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,9]]}}}