TB-CAPT CORE Truenat Trial

NACompletedINTERVENTIONAL
Enrollment

3,987

Participants

Timeline

Start Date

August 28, 2022

Primary Completion Date

June 16, 2024

Study Completion Date

December 31, 2024

Conditions
TuberculosisDiagnoses Disease
Interventions
DIAGNOSTIC_TEST

Truenat TB platform/TB assays

"Truenat TB platform/TB assays, a molecular diagnostic test developed by Molbio diagnostics, for the diagnosis of Mycobacterium tuberculosis complex (MTBC) and Truenat MTB-RIF Dx for detection of RIF resistance was endorsed in 2020 by the WHO for TB diagnosis.~The system has been designed to be operated as a point-of-care- diagnostic solution in peripheral laboratories with minimal infrastructure.~It takes about 25 minutes to do the DNA extraction and another 35 minutes to diagnose TB.~It is portable and battery operated, have no need for a computer or laptop, and operate from 2-40 C ambient temperature. The system uses room temperature stable reagents with long shelf life."

Trial Locations (4)

1100

Instituto Nacional de Saúde (INS), Maputo

1929

Centro de Investigação em Saúde de Manhiça-Fundação, Manhiça

2410

National Institute of Medical Research (NIMR), Mbeya

Box 78 373

Ifakara Health Institute, Dar es Salaam

All Listed Sponsors
collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

collaborator

Centro de Investigação em Saúde de Manhiça

OTHER

collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

collaborator

Ifakara Health Institute

OTHER

lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER