Evaluation of Centralized TB Assay Solutions
Not Applicable
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2022/08/044804
- Lead Sponsor
- Foundation for Innovative New Diagnostics India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Aged Equal ore more than 18 years.
2) Clinical suspicion of pulmonary TB including productive cough of equal or more than 2 weeks and equal or more than 1 week for other symptom typical of pulmonary TB listed below:
2.1. Fever
2.2. Contact with active case
2.3. Malaise
2.4. Haemoptysis
2.5. Recent weight Loss
2.6. Chest Pain
2.7. Night sweats
2.8. Loss of appetite
3) Willing to Provide two sputum specimens at enrollment
4) Willing to provide informed consent.
Exclusion Criteria
1) Only extra-pulmonary TB signs & symptoms
2) Receipt of any dose of TB treatment within 6 months prior to enrolment or currently on TB treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Diagnostic accuracy for MTB detection: clinical sensitivity <br/ ><br>and specificity by smear-status measured against <br/ ><br>mycobacterial culture as the reference standard.Timepoint: Baseline
- Secondary Outcome Measures
Name Time Method 1) Diagnostic accuracy for MTB detection:clinical point estimates of sensitivity and specificity measured against <br/ ><br>mycobacterial culture as the reference standard by sub gr oup. <br/ ><br>2) Operational characteristics - description of operator <br/ ><br>experience with the assays through daily observed usage and user appraisal questionnairesTimepoint: Baseline