{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T13:29:41Z","timestamp":1768570181163,"version":"3.49.0"},"posted":{"date-parts":[[2025,10,19]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":16,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:00:00Z","timestamp":1760832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2025,10,19]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Diagnosing tuberculosis in children remains challenging due to the paucibacillary nature of the disease, non-specific symptoms, and difficulty collecting samples. New tests are urgently needed. We evaluated the diagnostic accuracy of FujiLAM version 1 urine test in children under 5 years with presumptive tuberculosis in Uganda.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was a cross-sectional evaluation nested in the NOD-pedFEND diagnostic study. Children under 5 years with signs or symptoms of tuberculosis were recruited from three hospitals in Uganda. All participants underwent comprehensive baseline investigations, including culture and Xpert MTB\/RIF Ultra on reference samples and chest X-ray. Culture and Xpert MTB\/RIF Ultra results were used to define a microbiological reference standard. FujiLAM version 1 testing was performed on fresh urine at the baseline visit.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>\n                    Seventy-nine children were included in the study. Fifteen participants (19%) were classified as having microbiologically confirmed TB, 44 (56%) as unconfirmed TB, thirteen (16%) as unlikely TB, and seven participants (9%) were unclassifiable. Only one participant (with unlikely TB) had a positive FujiLAM test. Culture and Xpert MTB\/RIF Ultra on reference samples were negative in this child, indicating poor diagnostic accuracy with a sensitivity of 0% (95% CI: 0 \u2013 21.8) of FujiLAM version 1 against the microbiological reference standard.\n                    <jats:italic>Conclusion:<\/jats:italic>\n                    The poor diagnostic accuracy of FujiLAM version 1 in children under five years of age makes it unsuitable as a diagnostic test in this age group. Further evaluation with the optimized version 2 of this test is needed.\n                  <\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2025.10.17.25338231","type":"posted-content","created":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T07:30:14Z","timestamp":1760945414000},"source":"Crossref","is-referenced-by-count":0,"title":["PERFORMANCE OF FUJILAM VERSION 1 FOR THE DIAGNOSIS OF TUBERCULOSIS IN CHILDREN UNDER 5 YEARS IN UGANDA \u2013 A BRIEF REPORT"],"prefix":"10.64898","author":[{"given":"Mirembe Angella","family":"Nanteza","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nelson","family":"Mukiza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Freddie","family":"Bwanga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Musiime","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grace Paul","family":"Kisitu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathan","family":"Mudrak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nisreen","family":"Khambati","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Germine","family":"Nakayita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Nasinghe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prossy","family":"Mbekeka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rudie","family":"Desravines","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rutvi","family":"Upadhyay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Douglass","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adeodata R.","family":"Kekitiinwa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerrold J.","family":"Ellner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan E.","family":"Dorman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Penn-Nicholson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soyeon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Alland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Padmini","family":"Salgame","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rinn","family":"Song","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca Wanda","family":"Basile","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moses","family":"Joloba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Else Margreet","family":"Bijker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"issue":"4","key":"2025102209350599000_2025.10.17.25338231v1.1","doi-asserted-by":"crossref","first-page":"893","DOI":"10.1016\/j.pcl.2017.03.010","article-title":"Tuberculosis in Children","volume":"64","year":"2017","journal-title":"Pediatr Clin North Am"},{"key":"2025102209350599000_2025.10.17.25338231v1.2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(13)70008-2"},{"issue":"2","key":"2025102209350599000_2025.10.17.25338231v1.3","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1590\/s1806-37562017000000461","article-title":"Epidemiological aspects, clinical manifestations, and prevention of pediatric tuberculosis from the perspective of the End TB Strategy","volume":"44","year":"2018","journal-title":"J Bras Pneumol"},{"issue":"3","key":"2025102209350599000_2025.10.17.25338231v1.4","first-page":"EC32","article-title":"The diagnostic value of urine lipoarabinomannan (LAM) antigen in childhood tuberculosis","volume":"11","year":"2017","journal-title":"Journal of clinical and diagnostic research: JCDR"},{"key":"2025102209350599000_2025.10.17.25338231v1.5","unstructured":"WHO: Lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis of active tuberculosis in people living with HIV, Policy update 2019 edn. Geneva: World Health Organization; 2019."},{"key":"2025102209350599000_2025.10.17.25338231v1.6","doi-asserted-by":"publisher","DOI":"10.1016\/s1473-3099(19)30001-5"},{"key":"2025102209350599000_2025.10.17.25338231v1.7","doi-asserted-by":"publisher","DOI":"10.1136\/bmjpo-2022-001447"},{"issue":"1","key":"2025102209350599000_2025.10.17.25338231v1.8","doi-asserted-by":"crossref","first-page":"647","DOI":"10.1186\/s12887-025-05554-3","article-title":"Novel and optimized diagnostics for pediatric TB in endemic countries: NOD-pedFEND study protocol","volume":"25","year":"2025","journal-title":"BMC Pediatr"},{"key":"2025102209350599000_2025.10.17.25338231v1.9","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jis008"},{"issue":"9","key":"2025102209350599000_2025.10.17.25338231v1.10","doi-asserted-by":"crossref","first-page":"1914","DOI":"10.3390\/jcm10091914","article-title":"Diagnostic performance of the Fujifilm SILVAMP TB-LAM in children with presumptive tuberculosis","volume":"10","year":"2021","journal-title":"Journal of clinical medicine"},{"issue":"6","key":"2025102209350599000_2025.10.17.25338231v1.11","doi-asserted-by":"crossref","first-page":"714","DOI":"10.5588\/ijtld.18.0364","article-title":"Point-of-care urine lipoarabinomannan antigen detection for diagnosis of tuberculosis in children","volume":"23","year":"2019","journal-title":"The International Journal of Tuberculosis and Lung Disease"},{"key":"2025102209350599000_2025.10.17.25338231v1.12","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30598-3"},{"issue":"9","key":"2025102209350599000_2025.10.17.25338231v1.13","doi-asserted-by":"crossref","first-page":"e280","DOI":"10.1093\/cid\/ciaa1052","article-title":"Accuracy of a novel urine test, Fujifilm SILVAMP tuberculosis lipoarabinomannan, for the diagnosis of pulmonary tuberculosis in children","volume":"72","year":"2021","journal-title":"Clinical Infectious Diseases"},{"key":"2025102209350599000_2025.10.17.25338231v1.14","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00003315"},{"issue":"5","key":"2025102209350599000_2025.10.17.25338231v1.15","doi-asserted-by":"crossref","first-page":"e0303846","DOI":"10.1371\/journal.pone.0303846","article-title":"Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability","volume":"19","year":"2024","journal-title":"Plos one"},{"issue":"1","key":"2025102209350599000_2025.10.17.25338231v1.16","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","year":"2023","journal-title":"The Lancet Global Health"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1101\/2025.10.17.25338231","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T20:49:03Z","timestamp":1768510143000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.1101\/2025.10.17.25338231"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,19]]},"references-count":16,"URL":"https:\/\/doi.org\/10.1101\/2025.10.17.25338231","relation":{},"subject":[],"published":{"date-parts":[[2025,10,19]]},"subtype":"preprint"}}