PERFORMANCE OF FUJILAM VERSION 1 FOR THE DIAGNOSIS OF TUBERCULOSIS IN CHILDREN UNDER 5 YEARS IN UGANDA – A BRIEF REPORT

Background 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.

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.

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 – 21.8) of FujiLAM version 1 against the microbiological reference standard. Conclusion: 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. Competing Interest Statement The authors have declared no competing interest. Clinical Protocols https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-025-05554-3 Funding Statement The primary study, NOD-pedFEND, was funded by the National Institute of Allergy and Infectious Diseases (NIAID) through grant numbers 1R01AI152159 and 1U01AI152084. The nested study was supported by HEPI-SSHU and the views expressed herein are exclusively those of the authors and do not necessarily exemplify views of NIAID and HEPI-SSHU. EB is supported by a fellowship from the European Society for Paediatric Infectious Diseases. NM was supported by the Marshall Aid Commemoration Commission. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approval was obtained from the Makerere University School of Biomedical Sciences Higher Degree Research Ethics Committee, Uganda National Council for Science and Technology, University Ethics and Compliance at Rutgers, the State University of New Jersey, and the Oxford Tropical Research Ethics Committee (OxTREC). Written informed consent from parents/legal guardians was obtained, and the study procedures adhered to the Declaration of Helsinki. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes ↵^ See end of manuscript for names Data Availability Data used during this study is available upon reasonable request to the corresponding author. Abbreviations - FujiLAM - Fujifilm SILVAMP Tuberculosis LAM - MTB - Mycobacterium tuberculosis - HIV - Human Immunodeficiency Virus - NOD - Novel and Optimized Diagnostics - FEND - Feasibility of Novel Diagnostics for TB in Endemic Countries - NOD-pedFEND - the paediatric arm of the FEND study merged with the NOD study - HEPI-SSHU - Health Professional Education Partnership Initiative for Strengthening the Health System and Services in Uganda