# Development of a Rapid Low-Cost Fecal-based TB Diagnostic for Children

> **NIH NIH R41** · PULMONESCENCE DIAGNOSTICS, INC. · 2020 · $243,960

## Abstract

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. When children cough, they
usually swallow the sputum. It has been shown that feces, the ultimate destination of swallowed sputum, is
potentially a useful specimen for detection of TB in children. Indeed, viable Mycobacterium tuberculosis (Mtb)
has been shown to be present in fecal samples using culture studies. More recently, there has been a number
of attempts to adapt the GeneXpert® test to feces from children. While the analysis of stool specimens by
GeneXpert® potentially represents a new diagnostic test for pediatric TB, its use in peripheral settings is severely
limited. To solve this problem, we have designed and tested a rapid, low cost sputum-based diagnostic (REFtb)
for peripheral settings that could be modified for use as a pediatric fecal test. The broad objective of the proposed
research in this application is to adapt this sputum-based test to a fecal-based pediatric test. Based on
preliminary data, we believe that with minimal optimization the sputum REFtb assay can easily be adapted from
sputum to fecal matter as a diagnostic test. These studies will focus on adapting the sputum-based regents for
use in a pediatric fecal-based assay and testing the fecal-based assay in pediatric fecal material. We plan to
examine nonTB fecal material from children 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 fecal-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 fecal-based
pediatric TB diagnostic suitable for low resource peripheral settings. This fecal-based pedia...

## Key facts

- **NIH application ID:** 10080649
- **Project number:** 1R41AI155206-01
- **Recipient organization:** PULMONESCENCE DIAGNOSTICS, INC.
- **Principal Investigator:** Jeffrey D. Cirillo
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $243,960
- **Award type:** 1
- **Project period:** 2020-08-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080649

## Citation

> US National Institutes of Health, RePORTER application 10080649, Development of a Rapid Low-Cost Fecal-based TB Diagnostic for Children (1R41AI155206-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10080649. Licensed CC0.

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