FujiLAM Prospective Evaluation Trial

Conditions

Diagnosis of Tuberculosis in People Living With HIV

Keywords

tuberculosis, PLHIV

Brief summary

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).

Sossen B, Székely R, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, Van Nguyen H, Ubolyam S, Erkosar B, Vermeulen M, Centner CM, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Nguyen NV, Avihingsanon A, Kerkhoff AD, Denkinger CM, Reither K, Nakiyingi L, MacPherson P, Meintjes G, Ruhwald M, FujiLAM Study Consortium.

2024-12-017 citations

10.1016/s2214-109x(24)00357-7

A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries

Tinne Gils, Jerry Hella, Bart K. M. Jacobs, Bianca Sossen, Madalo Mukoka et al. (28 authors)

The Journal of Infectious Diseases2024-07-249 citations

10.1093/infdis/jiae374

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

Rita Székely, Bianca Sossen, Madalo Mukoka, Monde Muyoyeta, Elizabeth Nakabugo et al. (29 authors)

PLoS ONE2024-05-3124 citations

10.1371/journal.pone.0303846

User perspectives and preferences on a novel TB LAM diagnostic (Fujifilm SILVAMP TB LAM)–a qualitative study in Malawi and Zambia

Yannis Herrmann, Federica Lainati, María del Mar Castro, Chanda Mwamba, Moses Kumwenda et al. (13 authors)

PLOS Global Public Health2022-07-1910 citations

10.1371/journal.pgph.0000672

Interventions

DEVICEFujifilm SILVAMP TB LAM

Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Adult PLHIV (≥18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB * Inpatients: irrespective of TB symptoms * Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO\*) * written informed consent * willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate)

Exclusion criteria

* Current anti-TB treatment \* * Any anti-TB treatment within 60 days prior to enrolment * Any isoniazid preventive therapy within 6 months prior to enrolment \* Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment.

Design outcomes

Primary

Measure	Time frame
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.	Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.	Day 1
Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens).	Day 1

Countries

Malawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia

Outcome results

None listed