PROJECT

“Prospective multicenter evaluation of feasibility and performance of blood-based point-of-care triage test for tuberculosis in intended settings of use”

February 2025 - February 2027

Objectives:

To evaluate the sensitivity and specificity of the blood-based point-of-care TB test. To assess the feasibility of using the blood-based point-of-care TB test in its intended setting of use (NTEP clinics/Designated Microscopy Centres).

Study Overview:

Most individuals suspected to have TB do not end up with a positive diagnosis of TB. In this scenario, it would be most useful to have a rapid and affordable triage test that can narrow down the population that will need to undergo confirmatory testing by molecular tests or culture which are expensive. Availability of such a test will considerably reduce the cost of testing, as well as the work load at the peripheral laboratories. Currently there is no such test which meets WHO’s target product profile, and this study is aimed at evaluating the performance of one such test developed by Ms. Stellar Diagnostics Pvt. Ltd

Study Approach:

(i) Pilot phase: The purpose of this phase is to demonstrate that results of the PoC test done using finger prick blood in the NTEP clinics mirror that obtained with patients’ serum or plasma in the reference lab. This phase will be carried out at 2 sites (ICMR-NIRT, Chennai and NITRD, New Delhi) and include 200 presumptive TB cases.
(ii) Validation phase: This phase is meant to validate the performance characteristics and operational feasibility of the PoC test in the NTEP clinics. This phase will include 4 sites (NIRT-Chennai, NIRT-Madurai, NITRD-New Delhi, RMRC-Bhubaneshwar) and include 2500 adult presumptive TB cases and 400 controls.

Expected Public Health Impact:

If the study reveals satisfactory performance of the test in correctly identifying individuals who need to undergo costly TB diagnostic tests and demonstrates the ease of performance of the test in the field sites, the test can be adopted into the program for quick triaging of TB cases and contribute to significant cost saving for the country.