Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: FluoroType MTBDR V2 assay: The investigational product (FluoroType MTBDR V2 assay) are intended for the
detection of M. tuberculosis in sputum as well as the detection of M. tuberculosi
Sponsors
Foundation for Innovative New Diagnostics India
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Diagnostic accuracy for MTB detection: clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Diagnostic accuracy for MTB detection:clinical point estimates of sensitivity and specificity measured against mycobacterial culture as the reference standard by sub gr oup. 2) Operational characteristics - description of operator experience with the assays through daily observed usage and user appraisal questionnairesTimepoint: Baseline | — |
Countries
India
Contacts
Public ContactDr R Priya
ICMR- National Institute for Research in Tuberculosis
Outcome results
None listed