# Enhancing Pediatric Diagnosis of Tuberculosis with FLOW Technology

> **NIH NIH R44** · SALUS DISCOVERY, LLC · 2024 · $818,507

## Abstract

ABSTRACT
While proper diagnosis is key to effective TB treatment, there exist specific barriers to TB testing in low resource
settings, especially for children. While a number of TB diagnostic tools are available, they each suffer from critical
drawbacks (difficult, inaccurate, expensive) that limit their widespread implementation in low resource settings
and their feasibility in children. A mycobacterial cell wall glycolipid, lipoarabinomannan (LAM), as a diagnostic
pathogen biomarker has been widely demonstrated and one point-of-care (POC) LAM assay (Alere Determine™
TB LAM) is currently on the market. Alere’s technology incorporates LAM detection in a urine-based lateral flow
assay (LFA) and while easy to use, its poor diagnostic sensitivity limits its utility to patients with extremely high
LAM concentrations (e.g., patients with advanced HIV disease and CD4 counts <100). This limitation is
particularly problematic in children, given their higher incidence of paucibacillary TB (when LAM concentration
is likely even lower).
In this study we will bridge the gap between the unmet need for TB diagnostics in children and the use of LAM
as a promising solution by applying an emerging technology, termed “FLOW”, to enhance the sensitivity of the
LAM LFA. While the Alere LFA measures LAM from only a few droplets of urine, FLOW concentrates LAM from
several mL of urine into ~100 µL, which is then assayed by the LFA. Importantly, FLOW concentration is
completely passive, requiring little or no additional steps beyond LFA-based analysis, thus making it a simple
and user friendly “front end” for LFAs, especially within low resource settings where TB is most prominent. As
proof of principle, in a small, adult only, first-in-human (FIH) study performed in South Africa (funded by the Bill
and Melinda Gates Foundation, see letter of support), running FLOW-concentrated urine on Alere and (our newly
developed) Salus LFAs resulted in doubling of clinical sensitivity.
In this FastTrack SBIR proposal we will optimize and adapt FLOW for the diagnosis of TB in pediatric patients
by: In Aim 1, optimizing the FLOW technology to maximize analytical sensitivity among children with TB; In Aim
2, assessing clinical sensitivity in a small, pediatric only, pilot study performed at our partner clinical research
site in South Africa; In Aim 3, implementing necessary changes and/or improvements as needed and develop
an improved collection-to-answer workflow for our device, including furthering the development the Salus LFA.
Additionally, we propose to develop a “wearable” adaptor, geared toward the very young (e.g. ages 0-4) and
very sick, that will plug into our FLOW workflow and allow for efficient sample collection and assessment of
patient TB status; and in Aim 4 employing our FLOW TB assay back to South Africa for a properly powered
study, the results of which will provide a foundation for our route to commercialization (Aim 5). Importantly, we
have already identified par...

## Key facts

- **NIH application ID:** 10620287
- **Project number:** 5R44HD101201-03
- **Recipient organization:** SALUS DISCOVERY, LLC
- **Principal Investigator:** Brianna Mullins
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $818,507
- **Award type:** 5
- **Project period:** 2022-05-10 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10620287

## Citation

> US National Institutes of Health, RePORTER application 10620287, Enhancing Pediatric Diagnosis of Tuberculosis with FLOW Technology (5R44HD101201-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10620287. Licensed CC0.

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