{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T06:49:11Z","timestamp":1792046951463,"version":"4.4.0"},"reference-count":44,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n Leptospirosis is a globally prevalent zoonotic disease that remains challenging to diagnose due to its nonspecific symptoms and the limitations of current diagnostic methods and targets. To address these challenges, we developed and validated a naked\u2010eye loop\u2010mediated isothermal amplification (LAMP) assay targeting the newly identified orpH region for the rapid detection of pathogenic Leptospira species.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Comparative genomic analysis identified orpH as a conserved sequence among pathogenic Leptospira. A colorimetric LAMP assay (LAMP\u2010orpH) was developed and evaluated using reference strains and serum samples obtained from patients with suspected leptospirosis. The diagnostic performance of the assay on these serum samples was evaluated in comparison with conventional PCR and the microscopic agglutination test (MAT), with the real\u2010time PCR assay targeting lipL32 designated as the reference standard.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The LAMP\u2010\n orpH<\/jats:italic>\n assay demonstrated 87.2% sensitivity and 94.8% specificity among 76 suspected cases and 29 controls, showing strong agreement with real\u2010time PCR (\n \u03ba<\/jats:italic>\n \u2009=\u20090.826). It outperformed MAT (63.8% sensitivity) and conventional PCR (23.4% sensitivity), achieving a detection limit of 10\n 2<\/jats:sup>\n cells\/mL in spiked serum.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n The LAMP\u2010\n orpH<\/jats:italic>\n assay offers a rapid, sensitive, and specific tool for early leptospirosis diagnosis. Its simple colorimetric readout and minimal equipment requirements make it ideal for use in rural and resource\u2010limited settings, providing a practical alternative to MAT, conventional PCR, and qPCR.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/jcla.70277","type":"journal-article","created":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T06:25:27Z","timestamp":1792045527000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Novel Target for Pathogenic Leptospira Detection via Colorimetric Loop\u2010Mediated Isothermal Amplification (\n LAMP<\/scp>\n ): Development, Validation, and Comparative Analysis"],"prefix":"10.1002","author":[{"given":"Peyman","family":"Ghoraishizadeh","sequence":"first","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8647-5669","authenticated-orcid":false,"given":"Benjie","family":"Clemente","sequence":"additional","affiliation":[{"name":"Department of Medical Technology, Faculty of Pharmacy University of Santo Tomas Manila Philippines"},{"name":"The Graduate School, University of Santo Tomas Manila Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kween","family":"Saimuang","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sakaorat","family":"Lertjuthaporn","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukhonta","family":"limsampan","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patcharapan","family":"Suwannin","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mongkol","family":"Techakasikornpanich","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Galayanee","family":"Doungchawee","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edilberto","family":"Manahan","sequence":"additional","affiliation":[{"name":"Department of Medical Technology, Faculty of Pharmacy University of Santo Tomas Manila Philippines"},{"name":"School of Health Sciences University of Santo Tomas General Santo Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4181-3425","authenticated-orcid":false,"given":"Kulachart","family":"Jangpatarapongsa","sequence":"additional","affiliation":[{"name":"Center for Research Innovation and Biomedical Informatics, Faculty of Medical Technology Mahidol University Nakhon Pathom Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,14]]},"reference":[{"issue":"13","key":"e_1_2_12_2_1","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.2460\/javma.22.06.0258","article-title":"A Global One Health Perspective on Leptospirosis in Humans and Animals","volume":"260","author":"Sykes J. 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J. M.","year":"2021","journal-title":"Journal of Biomolecular Techniques: JBT"},{"issue":"4","key":"e_1_2_12_37_1","doi-asserted-by":"crossref","first-page":"277","DOI":"10.1007\/978-1-0716-0459-5_25","article-title":"Laboratory Diagnosis of Leptospirosis","volume":"2134","author":"Koizumi N.","year":"2020","journal-title":"Methods in Molecular Biology"},{"issue":"1","key":"e_1_2_12_38_1","doi-asserted-by":"crossref","first-page":"3","DOI":"10.4103\/0974-777X.192967","article-title":"Utility of Loop\u2010Mediated Isothermal Amplification Assay, Polymerase Chain Reaction, and Elisa for Diagnosis of Leptospirosis in South Indian Patients","volume":"9","author":"Sengupta M.","year":"2017","journal-title":"Journal of Global Infectious Diseases"},{"issue":"48","key":"e_1_2_12_39_1","article-title":"Evaluation of Surveillance Case Definition in the Diagnosis of Leptospirosis, Using the Microscopic Agglutination Test: A Validation Study","volume":"9","author":"Dassanayake D. L. 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