medRxiv : the preprint server for health sciences · 2025
PERFORMANCE OF FUJILAM VERSION 1 FOR THE DIAGNOSIS OF TUBERCULOSIS IN CHILDREN UNDER 5 YEARS IN UGANDA - A BRIEF REPORT.
СтатьяПрепринтНазвание и аннотация: Перевод в очереди
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Nanteza Mirembe Angella, Mukiza Nelson, Bwanga Freddie, Musiime Victor, Kisitu Grace Paul, Mudrak Nathan, Khambati Nisreen, Nakayita Germine, Nasinghe Emmanuel, Mbekeka Prossy, Desravines Rudie, Upadhyay Rutvi, Douglass Emily, Kekitiinwa Adeodata R, Ellner Jerrold J, Dorman Susan E, Penn-Nicholson Adam, Kim Soyeon, Alland David, Salgame Padmini, Song Rinn, Basile Francesca Wanda, Joloba Moses, Bijker Else Margreet
Аннотация
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.
METHODS: 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.
RESULTS: 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.
METHODS: 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.
RESULTS: 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.