MedTrace Logo

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

NCT03712709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1926

Last updated 2020-08-06

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Burnet Institute

    collaborator OTHER

  • National Institute for Research in Tuberculosis, Chennai, India

    collaborator UNKNOWN

  • Universidad Peruana Cayetano Heredia

    collaborator OTHER

  • Ethiopian Public Health Institute

    collaborator OTHER_GOV

  • PD Hinduja Hospital and Medical Research Centre, Mumbai, India

    collaborator UNKNOWN

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2020-07-09
Completion
2020-07-09

Countries

  • Ethiopia
  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712709 on ClinicalTrials.gov