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

CompletedOBSERVATIONAL
Enrollment

1,926

Participants

Timeline

Start Date

March 12, 2019

Primary Completion Date

July 9, 2020

Study Completion Date

July 9, 2020

Conditions
Tuberculosis, Pulmonary
Interventions
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.

Trial Locations (4)

Unknown

EPHI, Addis Ababa

State TB and Demonstration Center, Ahmedabad

NIRT, Chennai

PD Hinduja Hospital, Mumbai

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Burnet Institute

OTHER

collaborator

National Institute for Research in Tuberculosis, Chennai, India

UNKNOWN

collaborator

Universidad Peruana Cayetano Heredia

OTHER

collaborator

Ethiopian Public Health Institute

OTHER_GOV

collaborator

PD Hinduja Hospital and Medical Research Centre, Mumbai, India

UNKNOWN

lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER