Trials / Completed
CompletedNCT03712709
Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test
Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,926 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Truenat MTB | The Truenat MTB (including both MTB and MTB Plus) and the MTB-RIF Dx reflex assays (Molbio Diagnostics; Bangalore, India) utilize chip-based real-time micro-PCR for detection of tuberculosis (TB) and rifampicin (RIF) resistance from DNA extracted (on a separate device) from sputum samples. The Truenat MTB assay targets a single copy gene while the MTB Plus assay combines detection of a single copy and multi-copy gene. |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2020-07-09
- Completion
- 2020-07-09
- First posted
- 2018-10-19
- Last updated
- 2020-08-06
Locations
4 sites across 2 countries: Ethiopia, India
Source: ClinicalTrials.gov record NCT03712709. Inclusion in this directory is not an endorsement.