Trials / Completed
CompletedNCT04089423
FujiLAM Prospective Evaluation Trial
Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,731 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fujifilm 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. |
Timeline
- Start date
- 2019-12-13
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2019-09-13
- Last updated
- 2022-01-25
Locations
7 sites across 7 countries: Malawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia
Source: ClinicalTrials.gov record NCT04089423. Inclusion in this directory is not an endorsement.