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

  1. Mirembe Angella Nanteza
  2. Nelson Mukiza
  3. Freddie Bwanga
  4. Victor Musiime
  5. Grace Paul Kisitu
  6. Nathan Mudrak
  7. Nisreen Khambati
  8. Germine Nakayita
  9. Emmanuel Nasinghe
  10. Prossy Mbekeka
  11. Rudie Desravines
  12. Rutvi Upadhyay
  13. Emily Douglass
  14. Adeodata R. Kekitiinwa
  15. Jerrold J. Ellner
  16. Susan E. Dorman
  17. Adam Penn-Nicholson
  18. Soyeon Kim
  19. David Alland
  20. Padmini Salgame
  21. Rinn Song
  22. Francesca Wanda Basile
  23. Moses Joloba
  24. Else Margreet Bijker
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Abstract

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.

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