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NIH grant 1R41AI197272-01: Non-Invasive Rapid Test for Pediatric Tuberculosis
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: Jeffrey D. Cirillo. Award: $312276.
Start: 2026-07-22T00:00:00.
Project Summary
Tuberculosis (TB) causes more deaths worldwide than any other infectious disease, yet in the past, the impact
of TB on children has been often dismissed or minimized. Poor diagnosis and reporting of tuberculosis (TB) in
infants and children continue to hinder accurate estimates of the TB burden in children and the worldwide burden
of tuberculosis remains high among children. The diagnosis of TB in children is challenging at present due to a
lack of a sensitive point-of-care diagnostic tests, low access to and use of available tests, and difficulties of
obtaining sputum specimens from children with TB. Moreover, available clinical tests need sufficient
infrastructure support for the testing process such as a stable power supply, trained personnel, or lab facilities
which preclude their use in peripheral settings. Many are also cost prohibitive for low resource countries where
TB load is high. Currently, there is a great need for low-cost rapid non-sputum TB diagnostics for children and a
more accessible sample that can be obtained with minimal skill at primary health care level for use in an
alternative diagnostic would be highly desirable for the diagnosis of TB in children. We have designed and tested
a rapid, low-cost sputum-based diagnostic (REFtb) for peripheral settings that could be used as a starting point
for the development of a pediatric urine test. The broad objective of the proposed research in this application is
develop a urine-based pediatric test based on our knowledge of a sputum-based test. We plan to examine nonTB
urine for interference activities to the REFtb test and test known inhibitors of the sputum-based REFtb test in
order to develop an optimized reagent mix for the urine-based test. Longer term we plan to continue development
to develop a shelf-stable pediatric test and test the shelf-stable diagnostic in preliminary clinical trials. Completion
of this proposed research will result in the development of a urine-based pediatric TB diagnostic suitable for low
resource peripheral settings. This urine-based pediatric REFtb system overcomes the financial and geographical
barriers that currently limit early TB detection so children with TB that currently go undiagnosed can now be
diagnosed in a low-cost and rapid manner.document fetched 2026-08-02 08:24