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| Name | Class |
|---|---|
| Centre for Infectious Disease Research in Zambia | OTHER |
| Infectious Diseases Institute, Uganda | OTHER |
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | OTHER |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fujifilm SILVAMP TB LAM | Device | Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification. |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult people living with HIV
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| Name | Affiliation | Role |
|---|---|---|
| Morten Ruhwald, MD | FIND Head of TB programme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Blantyre | Box 30096 | Malawi | |||
| CIDRI-Africa University of Cape Town |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39577975 | Derived | Sossen B, Szekely 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. Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study. Lancet Glob Health. 2024 Dec;12(12):e2024-2034. doi: 10.1016/S2214-109X(24)00357-7. | |
| 39046150 |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Swiss Tropical & Public Health Institute |
| OTHER |
| Ifakara Health Institute | OTHER |
| University of Cape Town | OTHER |
| Viet Tiep Hospital | OTHER |
| National Tuberculosis Control Programme | UNKNOWN |
| Fujifilm | INDUSTRY |
| Omega Diagnostics | UNKNOWN |
| Tuberculosis and Lung Disease Hospital in Hai Phong | UNKNOWN |
| The HIV Netherlands Australia Thailand Research Collaboration | OTHER |
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| Cape Town |
| 7925 |
| South Africa |
| Ifakara Health Institute | Dar es Salaam | Box 78 373 | Tanzania |
| The HIV Netherlands Australia Thailand Research collaboration | Bangkok | Bankok | Thailand |
| Infectious Diseases Institute | Kampala | Box 22418 | Uganda |
| Viet Tiep Hospital | Haiphong | Le Chan | Vietnam |
| Centre for Infectious Disease Research in Zambia | Lusaka | 34620 | Zambia |
| Derived |
| Gils T, Hella J, Jacobs BKM, Sossen B, Mukoka M, Muyoyeta M, Nakabugo E, Van Nguyen H, Ubolyam S, Mace A, Vermeulen M, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Denkinger CM, Nguyen NV, Avihingsanon A, Nakiyingi L, Szekely R, Kerkhoff AD, MacPherson P, Meintjes G, Reither K, Ruhwald M. A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries. J Infect Dis. 2025 Feb 4;231(1):e82-e90. doi: 10.1093/infdis/jiae374. |
| 38820372 | Derived | Szekely R, Sossen B, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, Nguyen HV, Ubolyam S, Chikamatsu K, Mace A, Vermeulen M, Centner CM, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Mitarai S, Nguyen NV, Avihingsanon A, Reither K, Nakiyingi L, Kerkhoff AD, MacPherson P, Meintjes G, Denkinger CM, Ruhwald M; FujiLAM Study Consortium. 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. PLoS One. 2024 May 31;19(5):e0303846. doi: 10.1371/journal.pone.0303846. eCollection 2024. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |