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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diagnosis of Tuberculosis in People Living With HIV
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Enrollment
- 1731
- Locations
- 7
- Primary Endpoint
- Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
Time Frame: Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.
Time Frame: 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).
Time Frame: Day 1