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

Foundation for Innovative New Diagnostics, Switzerland1,926 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,926

Conditions

Tuberculosis, Pulmonary

Interventions

Truenat MTBDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (4)

EPHI

Addis Ababa, Ethiopia

State TB and Demonstration Center

Ahmedabad, India

NIRT

Chennai, India

PD Hinduja Hospital

Mumbai, India

Outcomes

Primary Outcomes

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

Time frame: Day 1

Secondary Outcomes

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) .

Time frame: 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.

Time frame: 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.

Time frame: Day 1

Time to TB detection and RIF resistance detection.

Assess patient important outcomes, including time to detection of TB and RIF resistance.

Time frame: Day 1

Data from ClinicalTrials.gov

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