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Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
Sponsor: Mercy Corps Pakistan
Summary
This study evaluates two portable molecular tests for tuberculosis (TB), Pluslife MTBC and Ustar PortNAT, during community-based active case-finding activities in Pakistan. It compares testing of tongue swabs and sputum swabs with the routinely used sputum Xpert MTB/RIF Ultra test. Mycobacterial culture is the microbiological reference standard used to assess diagnostic accuracy. The study examines how often each test detects TB when culture is positive and how often it gives a negative result when culture is negative. Results will be assessed separately for each test and specimen type. The study also compares specimen collection, test usability, costs and time to results, and explores participants' and health-care workers' experiences and preferences regarding tongue-swab and sputum collection.
Official title: Evaluation of Portable Nucleic Acid Amplification Tests for Tuberculosis Active Case Finding in Pakistan
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6100
Start Date
2026-02-20
Completion Date
2027-03-31
Last Updated
2026-10-27
Healthy Volunteers
Yes
Conditions
Interventions
Paired tongue-swab and sputum-based molecular testing for tuberculosis
Collection of tongue swabs and sputum specimens during routine community-based active case finding. Tongue-swab and sputum-swab specimens are evaluated separately using Pluslife MTBC and Ustar PortNAT. Sputum Xpert MTB/RIF Ultra is the comparator and sputum mycobacterial culture is the microbiological reference standard. Diagnostic tests are performed on matched specimens from the same participant under the study laboratory procedures. Participants who cannot provide sputum remain eligible for tongue-swab collection under the revised criteria; unavailable sputum-based tests or cultures are recorded as unavailable, not negative. Diagnostic accuracy, paired sensitivity differences, collection success, validity, turnaround time, costs and acceptability are evaluated as specified in the protocol and analysis plans.
Locations (2)
National Reference Laboratory
Islamabad, Federal Capital, Pakistan
Provincial Reference Laboratory, Dow University of Health Sciences
Karachi, Sindh, Pakistan