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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).
Condition or disease
Diagnosis of Tuberculosis in People Living With HIV
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult people living with HIV
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)
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.