Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test

Study Overview
=================
Brief 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.

Official Title
-----------------
Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use

Conditions
-----------------
Tuberculosis, Pulmonary

Intervention / Treatment
-----------------
* Diagnostic Test: Truenat MTB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case Detection Group: Age 18 years or above Clinical suspicion of pulmonary TB (including cough ≥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. Drug Resistant TB Group: In addition to the criteria of the Case Detection Group, participants should also meet the following conditions: Non-converting pulmonary TB cases (category I and category II failures) 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Detection Group<br>Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB). Only participants who have not received any form of TB treatment within the prior 60 days will be enrolled | Diagnostic Test: Truenat MTB<br>* 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.<br>* Other names: Truenat MTB-RIF Dx;|
| Drug Resistant TB Group<br>In addition to the criteria of the Case Detection Group, participants should also meet the following conditions: Non-converting pulmonary TB cases (category I and category II failures). | Diagnostic Test: Truenat MTB<br>* 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.<br>* Other names: Truenat MTB-RIF Dx;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay | 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 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay | Estimate diagnostic accuracy of the Truenat MTB-RIF Dx assay for RIF resistance detection among individuals undergoing evaluation for pulmonary TB and DR TB, using phenotypic/genotypic drug susceptibility testing (DST) . | Day 1 | 
| Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay compared to Xpert MTB/RIF | Compare the diagnostic accuracy of the Truenat assays (MTB and MTB Plus) to that of Xpert MTB/RIF, using a reference standard of culture for TB diagnosis and phenotypic/genotypic DST for detection of RIF resistance. | Day 1 | 
| Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB-RIF Dx assay compared to Xpert MTB/RIF | Compare the diagnostic accuracy of the Truenat MTB-RIF Dx assay to that of Xpert MTB/RIF, using a reference standard of culture for TB diagnosis and phenotypic/genotypic DST for detection of RIF resistance. | Day 1 | 
| Time to TB detection and RIF resistance detection. | Assess patient important outcomes, including time to detection of TB and RIF resistance. | Day 1 |