NCT04089423

FujiLAM Prospective Evaluation Trial

Completed Last updated 25 January 2022

What this trial tests

trial testing Fujifilm SILVAMP TB LAM in Diagnosis of Tuberculosis in People Living With HIV in 1,731 participants. Completed in 31 December 2021.

Timeline

13 December 2019

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,731
Start date	13 December 2019
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	7 locations across South Africa, Malawi, Vietnam, Zambia, Thailand, Tanzania, Uganda

Drugs / interventions tested

• Fujifilm SILVAMP TB LAM

Conditions studied

• Diagnosis of Tuberculosis in People Living With HIV — all drugs for Diagnosis of Tuberculosis in People Living With HIV →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

18 and older, any sex, with Diagnosis of Tuberculosis in People Living With HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Székely R, Sossen B, Mukoka M, Muyoyeta M, et al · · 2024 · cited 24× · PMID 38820372 · DOI 10.1371/journal.pone.0303846
2. Diagnostic accuracy of a novel point-of-care urine lipoarabinomannan assay for the detection of tuberculosis among adult outpatients in Zambia: a prospective cross-sectional study.
   Muyoyeta M, Kerkhoff AD, Chilukutu L, Moreau E, et al · · 2021 · cited 14× · PMID 33926972 · DOI 10.1183/13993003.03999-2020
3. User perspectives and preferences on a novel TB LAM diagnostic (Fujifilm SILVAMP TB LAM)-a qualitative study in Malawi and Zambia.
   Herrmann Y, Lainati F, Castro MDM, Mwamba CP, et al · · 2022 · cited 12× · PMID 36962216 · DOI 10.1371/journal.pgph.0000672
4. A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.
   Gils T, Hella J, Jacobs BKM, Sossen B, et al · · 2025 · cited 10× · PMID 39046150 · DOI 10.1093/infdis/jiae374
5. Implementation of the advanced HIV disease care package with point-of-care CD4 testing during tuberculosis case finding: A mixed-methods evaluation.
   Gils T, Kamele M, Madonsela T, Bosman S, et al · · 2023 · cited 10× · PMID 38134020 · DOI 10.1371/journal.pone.0296197
6. Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study.
   Sossen B, Székely R, Mukoka M, Muyoyeta M, et al · · 2024 · cited 9× · PMID 39577975 · DOI 10.1016/s2214-109x(24)00357-7
7. Diagnostic Accuracy of Urine Lipoarabinomannan Testing in Early Morning Urine versus Spot Urine for Diagnosis of Tuberculosis among People with HIV.
   Bjerrum S, Åhsberg J, Szekely R, Opintan J, et al · · 2022 · cited 2× · PMID 35357206 · DOI 10.1128/spectrum.00208-22
8. Multicentre accuracy trial of FUJIFILM SILVAMP TB LAM test in people with HIV reveals lot variability
   Székely R, Sossen B, Mukoka M, Muyoyeta M, et al · · 2022 · cited 1× · DOI 10.1101/2022.09.07.22278961