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Standards Development to Ensure Reliable Breath Analysis in the Field

Summary

NIST’s Material Measurement Laboratory is developing prototype “breath in a bottle” reference materials and a breath surrogate delivery system to create matrix-matched materials that mimic the relevant characteristics of breath. The reference materials and delivery system are intended to benchmark the performance of sensor systems developed to identify individuals infected with malaria or tuberculosis.

Breathalyzer
Credit: N. Hanacek/NIST

Description

Numerous volatile organic compounds (VOCs) have been identified in human breath. These compounds can be produced by the body or by organisms in the body (e.g., bacteria or viruses) and provide a non-invasive window into human health. Inexpensive point-of-care devices are being developed to diagnose disease, including subclinical disease, from breath volatiles and monitor the efficacy of treatment. Sensor systems under development for this purpose cannot be benchmarked or validated without the ability to deliver reproducible breath surrogates to the devices. Breath surrogates must contain compounds relevant to the disease(s) in question, at relevant concentrations, and must also mimic other characteristics of human breath (e.g., temperature, humidity, carbon dioxide content, and oxygen content), and perhaps potential interferents that may be found in the breath of patients without the disease. 

K. M. Jeerage, J. L. Berry, J. A. Murray, C. A. Goodman, P. K. Piotrowski, C. M. Jones, C. E. Cecelski, J. Carney, K. A. Lippa, and T. M. Lovestead, 2022. The need for multicomponent gas standards for breath biomarker analysis, Journal of Breath Research 16, 044001, https://doi.org/10.1088/1752-7163/ac70ef

What does this project aim to do to enable reliable breath analysis?

This project will develop and characterize prototype reference materials and matrix-matched materials that can be delivered to sensors systems and devices. This project is funded in part through a Cooperative Research and Development Agreement with the Gates Foundation (CRADA, CN-23-0169). See the news story here.

What technical problems do we need to solve?

Initial work in clinical breath metrology identified the challenges of combining compounds from different chemical classes into a single reference material, achieving final concentrations at parts-per-billion levels, and reproducibly delivering matrix-matched materials. These challenges will be systematically investigated with a subset of VOCs identified in biomarker discovery studies of malaria and tuberculosis.

multicomponent gas
Credit: K. Jeerage
Created July 10, 2024, Updated July 11, 2024