Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test
Not Applicable
- Conditions
- TuberculosisPulmonary TuberculosisA00-B99J00-J99Special screening examination for respiratory tuberculosis
- Registration Number
- RBR-3www35z
- Lead Sponsor
- Departamento de Ciência e Tecnologia - DECIT. Secretaria de Ciência, Tecnologia e Insumos Estratégicos – SCTIE, Ministério da Saúde-MS (SCTIE/MS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Age 18 years or above; Clinical suspicion of pulmonary TB (including cough for at least 2 week and at least 1 other symptom typical of TB); Willingness to provide 3-4 sputum specimens at enrolment; Willingness to have a trial follow-up visit approximately 2 months after enrolment; Provision of informed consent.
Exclusion Criteria
Case Detection Group:Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).
Drug Resistant TB Group: Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay <br><br>Estimate diagnostic accuracy of the Truenat assays (MTB and MTB Plus) for Mycobacterium tuberculosis (MTB) detection among individuals undergoing evaluation for pulmonary TB, using a culture reference standard
- Secondary Outcome Measures
Name Time Method