Clinical Trial

Evaluation of New TB Diagnostic Tests (NATs) in Pakistan

Study acronym: TB
Enrolling by Invitation
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Record status
This record was last updated January 2, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to test new diagnostic methods for tuberculosis (TB) testing as compared to the existing Xpert MTB/Rif Ultra testing approach. The research questions that will be addressed by this study include: * What are the sensitivity and specificity of the new diagnostic tests Pluslife MTBC and Ustar PortNAT for tuberculosis and how do these compare to Xpert Ultra? * How does the new diagnostic method compare to Xpert Ultra in terms of implementation feasibility, cost and turnaround time? * What are the logistical and technical advantages and challenges associated with implementing the new diagnostic method compared to Xpert Ultra? * What are the perceptions of healthcare providers as well as sample provider regarding the usability, feasibility and convenience of use of the new sample collection method compared to existing methods?
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-14.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-12-31
Trial Details
NCT Number NCT06984887
Lead Sponsor Mercy Corps Pakistan
Collaborators: Centre for Global Public Health Pakistan, Royal Tropical Institute
Conditions Tuberculosis Diagnosis
Enrollment 6,100 participants
Start Date 2025-12-19
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-02