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Evaluation of New TB Diagnostic Tests (NATs) in Pakistan

NCT06984887 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6100

Last updated 2026-01-02

No results posted yet for this study

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?

Conditions

  • Tuberculosis Diagnosis

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Centre for Global Public Health Pakistan

    collaborator OTHER

  • Royal Tropical Institute

    collaborator OTHER

  • Mercy Corps Pakistan

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2026-05-31
Completion
2026-08-30

Countries

  • Pakistan

Study Locations

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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 NCT06984887 on ClinicalTrials.gov