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This study evaluates whether extrapulmonary tuberculosis — particularly TB serositis and TB meningitis — can be diagnosed on the same day using the IRISA-TB test. Patients aged 18 and over with symptoms of TB who can provide the required fluid sample may take part. The study is being run as a non-phase diagnostic study and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Male or female participants 18 years and over attending health care facility with symptoms of TB. 2. Serosal or CSF fluid sample provided to NHLS with sufficient volume to perform SOC tests + 1ml. 3. Patients in whom extrapulmonary TB is part of the treating clinicians' differential diagnosis. Exclusion Criteria: 1. Volunteers who refuse to sign informed consent and/or provide clinical details (Proxy consent will be obtained for participants who are incapacitated, with a follow up consent when they have recovered their capacity to consent) 2. Patients with current significant history of substance or alcohol abuse that may impact study visits. 3. Patients who are unable to communicate by telephone or who do not have a current active traceable contact number. 4. Patients not willing to undergo an HIV test. 5. Patients whose fluid sample volumes are insufficient to perform standard of care testing in addition to IRISA-TB 6. Positive sputum GXP within 2 weeks prior to serosal fluid or CSF sampling.