Clinical Evaluation of tNGS for Diagnosis of DR-TB

CompletedOBSERVATIONAL
Enrollment

800

Participants

Timeline

Start Date

April 16, 2021

Primary Completion Date

January 31, 2023

Study Completion Date

June 30, 2023

Conditions
Tuberculosis, Multidrug-Resistant
Interventions
DIAGNOSTIC_TEST

targeted Next Generation Sequencing (tNGS)

The index tests used in this trial will include up to three end-to-end, targeted next generation sequencing (tNGS) solutions for diagnosis of DR-TB. Each solution will include all of the equipment, reagents, and software necessary for handling the entire sequencing workflow, including DNA extraction from processed sputum samples (i.e. sediment), library preparation, sequencing, and data analysis/interpretation for clinical result reporting.

Trial Locations (3)

2192

National Institute for Communicable Diseases & Wits Health Consortium, Johannesburg

40016

Hinduja Hospital and Medical Research Centre, Mumbai

380060

National Center for Tuberculosis and Lung Diseases, Tbilisi

All Listed Sponsors
lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER