Evaluation of New TB Diagnostic Tests (NATs) in Pakistan

Mercy Corps Pakistan

Status

Invitation-only

Conditions

Tuberculosis Diagnosis

Treatments

Diagnostic Test: Diagnostic procedures

Study type

Interventional

Funder types

Other

Identifiers

NCT06984887

INV-045723

Details and patient eligibility

About

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?

Full description

Research Objective 1:

The study aims to assess the diagnostic accuracy-specifically the sensitivity and specificity-of two new NAT-based tuberculosis (TB) tests, Pluslife and Ustar. These tests will be compared against the existing reference standard, the Xpert MTB/Rif Ultra, with culture testing used as the gold standard. This evaluation will take place in the context of Active Case Finding (ACF) in Pakistan. The research will follow a non-inferiority diagnostic trial design. The procedure involves testing all samples with cultures and comparing the results from the new NAT tests against the reference to determine their effectiveness in detecting and diagnosing TB.

Expected Outcomes:

Sensitivity of the new NAT tests Specificity of the new NAT tests False positive rate False negative rate

Research Objective 2:

This objective focuses on evaluating the operational feasibility, cost-effectiveness, and turnaround time of the new NAT diagnostics compared to the Xpert Ultra platform. The strategy will involve both quantitative and qualitative research methods. Quantitative data will be collected and analyzed regarding the cost per test and the time taken from sample receipt to result reporting. In addition, a qualitative study will be conducted using semi-structured in-depth interviews with presumptive TB patients and healthcare providers involved in sample collection at ACF camp settings. These interviews will explore experiences, challenges, and preferences related to the use of sputum samples versus tongue swabs.

Expected Outcomes:

Cost per test performed Average turnaround time for each NAT platform Preferences of sample providers regarding collection methods Preferences of healthcare providers regarding sample collection methods Specific challenges associated with each collection method Barriers to compliance with sample collection Overall feasibility and ease of use of the diagnostic approaches

Research Objective 3:

The third objective seeks to assess the acceptability and usability of tongue swab-based sample collection compared to traditional sputum sample methods. This will be explored through a qualitative inquiry, gathering in-depth insights from both sample providers and healthcare workers to understand their perspectives, experiences, and any usability issues associated with each method.

Expected Outcomes:

Insights into user and provider acceptance of tongue swab versus sputum collection Identification of usability challenges and practical considerations in sample collection methods

Enrollment

6,100 estimated patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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