Evaluation of New TB Diagnostic Tests (NATs) in Pakistan

NCT06984887 | Enrolling By Invitation

• 1 other identifier: INV-045723
• Study Type: interventional
• Target: 6,100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

New TB diagnostics; New NATs for TB; Cost efficient TB diagnostic tools

Outcome Measures

Primary Outcomes (1)

• Number of participants with positive and negative Mycobacterium Tuberculosis

  The results of each of the test performed (negative and positive TB) using Pluslife MTBC test result, Ustar's PortNAT test result, Xpert MTB/Rif test result and results of the MTB culture.

  From enrolment to the end of results confirmation at 8 weeks

Study Arms (1)

Diagnostic Trial

EXPERIMENTAL

Diagnostic Test: Diagnostic procedures

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

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.

Diagnostic Trial

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People who are screened for TB on X-ray with CAD and their CAD scores are available
• Age range appropriate for the test (e.g., adult patients 12 yrs old and above)
• Any gender
• Consent to participate in the study and provide samples (e.g., tongue swab, sputum).

You may not qualify if:

• Pregnant women (depending on the diagnostic method or potential risks involved).
• Known cases of Pulmonary TB
• People who are unable to produce sputum
• Extra Pulmonary TB cases
• People who are not screened for TB on X-ray and/or their CAD scores are not available

Sponsors & Collaborators

• Centre for Global Public Health Pakistan: collaborator
• Royal Tropical Institute: collaborator
• Mercy Corps Pakistan: lead

Study Sites (1)

National Reference Laboratory

Islamabad, Federal Capital, 44000, Pakistan

Location

MeSH Terms

Interventions

Diagnostic Techniques and Procedures

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A diagnostic non-inferiority trial design will be followed to demonstrate that the new diagnostic tests (NAT) is equal to/not lesser than the existing standard test (Xpert MTB/Rif Assay). The aim of this trial is not to prove that the new test is better, but to show that the performance of the new tests is comparable to the current test which is used in ACF settings in Pakistan. The two new, the reference diagnostic test (Xpert Ultra) and the gold standard test (MTB culture) will be done in parallel to allow for a direct comparison of the two new tests and the reference test, performed on the same set of samples from each participant. This diagnostic evaluation study is cross-sectional in nature as it will typically involve assessing a diagnostic test's performance (such as sensitivity, specificity, etc.) at a single point in time. The key outcomes will be assessed using culture-confirmed TB and culture negative TB as a reference standard.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

PA (1)