Tests new portable tuberculosis diagnostics using tongue and sputum swabs in Pakistan
Compares two portable tests for tuberculosis with a standard test in community screening.
Plain-language title generated from the registry record
Registry title: Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
Key facts
- Where
- Islamabad and Karachi, PakistanSee the 2 sites
Where in Pakistan
- National Reference LaboratoryIslamabad, PakistanNo longer taking part
- Provincial Reference Laboratory, Dow University of Health SciencesKarachi, PakistanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mercy Corps Pakistan
- Trial code
- NCT06984887
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Evaluation of Portable Nucleic Acid Amplification Tests for Tuberculosis Active Case Finding in Pakistan
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.
Inclusion: Age 12 years or older; Attendance at a participating tuberculosis active case-finding activity with chest X-ray screening and an available computer-aided detection (CAD) score; Any sex; Informed consent to participate and willingness to provide at least one study specimen (tongue swab and/or sputum). Participants aged 12-17 years provide assent with parent or guardian consent in accordance with the approved protocol; Inability to produce sputum is not an exclusion criterion. Sputum induction may be offered under the study procedures. Participants unable to provide sputum remain eligible for tongue-swab collection; unavailable sputum-based test and culture results are recorded separately.
Exclusion: Known pulmonary tuberculosis; Known extrapulmonary tuberculosis; Refusal of informed consent or required assent/guardian consent; Inability to comply with study procedures or follow-up; Pregnancy; No chest X-ray screening or unavailable CAD score.