# Novel and Optimized Diagnostics for Pediatric TB

> **NIH NIH R01** · RBHS-NEW JERSEY MEDICAL SCHOOL · 2020 · $1,085,066

## Abstract

In response to RFA AI-19-036, investigators from Rutgers University, Makerere University, the Foundation for
Innovative New Diagnostics (FIND), McGill University, Frontier Sciences Boston, the US Centers for Disease
Control and Prevention, the Kenyan Medical Research Institute and Oxford University propose to study Novel
and Optimized Diagnostics (NOD) for Pediatric TB in a prospective study of well-characterized cohorts of children
<5 years of age in Uganda and by accessing the biorepository from a pediatric diagnostic study in Kenya. The
study populations are enriched for human immunodeficiency virus (HIV)-infected and HIV-exposed, uninfected
(HEU) children. The major advances in the diagnosis of adult tuberculosis (TB) have not extended to pediatric
TB. There are several reasons for this. Most children in high burden countries with symptoms compatible with
TB have limited access to clinical and laboratory facilities necessary for the diagnosis. Even at referral centers
where diagnosis is feasible, because of the paucibacillary nature of pediatric TB only a small proportion of
children that have a compatible clinical presentation can be bacteriologically confirmed. The current bacteriologic
reference standard for TB diagnosis requires difficult to obtain respiratory samples and has limited sensitivity.
The impact of HIV infection of and HIV-exposure on diagnostic accuracy is uncertain. Under- and misdiagnosis
of pediatric TB contributes to the high case-fatality rates that are highest in children <5 years of age and in those
with HIV infection. The novel approaches for TB diagnosis in children < 5 year of age that we propose address
the current needs: a) Point-of-care (POC) tests that avoid collections of respiratory specimens; b) increasing the
proportion of bacteriologically-confirmed cases with more sensitive diagnostics; and, c) stratification of children
with unconfirmed TB by their likelihood of having TB. We hypothesize that novel diagnostics that are currently
available or further optimized and new diagnostics based on whole genome sequencing (WGS) of cell free DNA
can address each of these needs. We will accomplish these goals in 3 specific aims: 1. Evaluate and develop
novel assays that diagnose TB by detecting Mycobacterium tuberculosis (MTB) bacterial products in non-sputum
body fluids comparing highly characterized children with microbiologically confirmed TB versus children
suspected but deemed unlikely to have TB (unlikely TB). 2. Evaluate and develop novel assays that diagnose
TB by detecting host biomarkers in non-sputum body fluids comparing children with confirmed TB versus unlikely
TB. 3. Identify combinations of assays that applied together could be used to diagnose TB among children
suspected of having TB but that are culture negative (unconfirmed TB). We will propose a new reference
standard for the diagnosis of TB that might contain host and bacteria-based assays. Once validated in large
observational studies and clinica...

## Key facts

- **NIH application ID:** 9986269
- **Project number:** 1R01AI152159-01
- **Recipient organization:** RBHS-NEW JERSEY MEDICAL SCHOOL
- **Principal Investigator:** David Alland
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,085,066
- **Award type:** 1
- **Project period:** 2020-05-07 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986269

## Citation

> US National Institutes of Health, RePORTER application 9986269, Novel and Optimized Diagnostics for Pediatric TB (1R01AI152159-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9986269. Licensed CC0.

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