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Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
Sponsor: Mercy Corps Pakistan
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?
Official title: An Evaluation of New TB Diagnostic Tests (NATs) for Active Case Finding for TB in Pakistan
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6100
Start Date
2025-12-19
Completion Date
2026-08-30
Last Updated
2026-01-02
Healthy Volunteers
Yes
Conditions
Interventions
Diagnostic procedures
This study will be evaluated by conducting a non-inferiority diagnostic trial within routine ACF settings by comparing the New Diagnostic tests (NAT) to the reference standard test (Xpert MTB/Rif Assay) to determine how well it can detect and diagnose TB. All samples will be tested for MTB using cultures.
Locations (1)
National Reference Laboratory
Islamabad, Federal Capital, Pakistan