{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T09:19:15Z","timestamp":1785403155998,"version":"3.56.0"},"reference-count":13,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T00:00:00Z","timestamp":1761177600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI22\/01834"],"award-info":[{"award-number":["PI22\/01834"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The Stop TB Partnership TB REACH","award":["CA-3-D000920001"],"award-info":[{"award-number":["CA-3-D000920001"]}]},{"name":"European and Developing Countries Clinical Trial Partnership","award":["EDCTP, DRIA2014-309"],"award-info":[{"award-number":["EDCTP, DRIA2014-309"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Tuberculosis (TB) remains a leading cause of death worldwide, with major diagnostic challenges in low-resource settings. Urine-based lipoarabinomannan (LAM) assays provide a non-invasive option, particularly for people living with HIV who may struggle to produce sputum. Fujifilm has developed a second-generation SILVAMP TB LAM assay (FujiLAM v.2) to improve diagnostic performance. This study aimed to evaluate the diagnostic accuracy of FujiLAM v.2 among Nigerian adults with presumptive TB and directly compare it with the first-generation assay (FujiLAM v.1) using the same set of urine samples. Methods: We conducted a retrospective analysis among Nigerian adults with presumptive TB (n = 178). Stored urine samples collected in Abuja were retested with FujiLAM v.2 and compared with results previously obtained using FujiLAM v.1 on the same specimens. Xpert MTB\/RIF and culture served as the reference standard. Sensitivity, specificity, agreement with the reference standard (Cohen\u2019s Kappa), and differences (McNemar\u2019s test) were assessed. Results: FujiLAM v.2 demonstrated sensitivity of 58.3% and specificity of 97.3%, comparable to FujiLAM v.1 (58.3% and 98.0%, respectively). No significant differences were found between test versions across TB or HIV subgroups (p &gt; 0.05). Overall agreement between assays was 97.1% (\u03ba = 0.80). Conclusions: FujiLAM v.2 showed diagnostic performance consistent with the first-generation assay, with similar sensitivity and specificity to the earlier version. These findings support its potential as a rapid, non-sputum-based diagnostic tool to complement TB testing in resource-limited settings. Further studies are needed to assess its implementation within TB diagnostic algorithms, including studies with multiple production lots.<\/jats:p>","DOI":"10.3390\/jcm14217524","type":"journal-article","created":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T02:34:45Z","timestamp":1761273285000},"page":"7524","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic Performance of Second-Generation Fujifilm SILVAMP TB LAM in Nigerian Adults with Presumptive Tuberculosis"],"prefix":"10.3390","volume":"14","author":[{"given":"Nadiia","family":"Tytarenko","sequence":"first","affiliation":[{"name":"Institut d\u2019Investigaci\u00f3 Germans Trias i Pujol, CIBER Enfermedades Respiratorias (CIBERES), Universitat Aut\u00f2noma de Barcelona, Carretera del Canyet, Cam\u00ed de les Escoles s\/n, 08916 Badalona, Barcelona, Spain"},{"name":"Microbiology, Virology and Biotechnology Department, Odesa National I.I. Mechnikov University, 65000 Odesa, Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7847-4271","authenticated-orcid":false,"given":"John S.","family":"Bimba","sequence":"additional","affiliation":[{"name":"Zankli Research Centre and Department of Community Medicine, Bingham University, Karu 961105, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didac","family":"Vulcano","sequence":"additional","affiliation":[{"name":"Institut d\u2019Investigaci\u00f3 Germans Trias i Pujol, CIBER Enfermedades Respiratorias (CIBERES), Universitat Aut\u00f2noma de Barcelona, Carretera del Canyet, Cam\u00ed de les Escoles s\/n, 08916 Badalona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2433-9864","authenticated-orcid":false,"given":"Patricia","family":"Comella-del-Barrio","sequence":"additional","affiliation":[{"name":"Institut d\u2019Investigaci\u00f3 Germans Trias i Pujol, CIBER Enfermedades Respiratorias (CIBERES), Universitat Aut\u00f2noma de Barcelona, Carretera del Canyet, Cam\u00ed de les Escoles s\/n, 08916 Badalona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Okoedoh","family":"Osazuwa","sequence":"additional","affiliation":[{"name":"Zankli Research Centre and Department of Community Medicine, Bingham University, Karu 961105, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4885-940X","authenticated-orcid":false,"given":"Jacob","family":"Creswell","sequence":"additional","affiliation":[{"name":"Innovations & Grants, Stop TB Partnership, 1218 Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Dom\u00ednguez","sequence":"additional","affiliation":[{"name":"Institut d\u2019Investigaci\u00f3 Germans Trias i Pujol, CIBER Enfermedades Respiratorias (CIBERES), Universitat Aut\u00f2noma de Barcelona, Carretera del Canyet, Cam\u00ed de les Escoles s\/n, 08916 Badalona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,23]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2024). Global Tuberculosis Report 2024, World Health Organization. Available online: https:\/\/www.who.int\/teams\/global-programme-on-tuberculosis-and-lung-health\/tb-reports\/global-tuberculosis-report-2024."},{"key":"ref_2","unstructured":"Gupta-Wright, A., Broger, T., Yerlikaya, S., and Denkinger, C.M. (2025). Next-Generation Urinary LAM Assays\u2014Are We There Yet?. Clin. Infect. Dis., ciaf081."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e126","DOI":"10.1016\/S2214-109X(22)00463-6","article-title":"Novel FujiLAM Assay to Detect Tuberculosis in HIV-Positive Ambulatory Patients in Four African Countries: A Diagnostic Accuracy Study","volume":"11","author":"Huerga","year":"2023","journal-title":"Lancet Glob. Health"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"World Health Organization (2024). Target Product Profiles for Tuberculosis Diagnosis and Detection of Drug Resistance, World Health Organization. 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Public Health, 9.","DOI":"10.3389\/fpubh.2021.757133"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/21\/7524\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T04:33:52Z","timestamp":1761366832000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/21\/7524"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,23]]},"references-count":13,"journal-issue":{"issue":"21","published-online":{"date-parts":[[2025,11]]}},"alternative-id":["jcm14217524"],"URL":"https:\/\/doi.org\/10.3390\/jcm14217524","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,23]]}}}