NCT06984887Enrolling by invitation
Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
Evaluation of Portable Nucleic Acid Amplification Tests for Tuberculosis Active Case Finding in Pakistan
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 6100 (estimated)
- First submitted
- 14 May 2025
- Start date
- 20 Feb 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Mercy Corps Pakistan
- Diseases
- Tuberculosis
- NCT number
- NCT06984887
What you commit to
- Study type: Interventional
- Planned participants: 6100
- From 20 Feb 2026 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known pulmonary tuberculosis.
- Known extrapulmonary tuberculosis.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Reference Laboratory Coordinator of this site? Confirm its status | Islamabad | Pakistan | Unknown status |
| Provincial Reference Laboratory, Dow University of Health Sciences Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.