Dr. Omar E. Rivera at BBCon 2024

00:00 Presentation ‘Evaluating Analytical Method Performance for Breath Analysis: An RST to assess lab performance

17:25 Question and answer session

Talk Abstract:

Confident, efficient, and reliable detection of TB biomarkers in patient’s breath is a path to disease detection and treatment to promote human health equity and equality. This project will develop a framework to ensure that breath researchers globally will have the tools to develop analytical methods such that the resulting data can be trusted and compared. The goal will be to incorporate established models[1-3] into a chemical space to determine what would be detectable in samples. We will also establish method performance parameters for expanding detectability of specific regions within the chemical space. This will be achieved via a scoring system that ensures robustness of analytical methods for chemical detection from breath matrix. The study will also provide a coverage map for breath VOCs, which will allow users to access information on appropriate analytical methodologies for specific VOCs of interest. Lack of guidance on selection of breath reference standards, and a lack of method criteria for the evaluation of data quality for reliably detecting and identifying breath biomarkers was the motivation of the research identified by OSEL/DBCMS and the Bill and Melinda Gates Foundation.

Acknowledgements:

The authors would like to acknowledge the Bill & Melinda Gates Foundation for their support of this study.

References

1. Bose, A., Westmoreland, P.R., J. Phys. Chem. A 2020, 124, 10600−10615.

2. Black G. et al. Analytical and Bioanalytical Chemistry 2023, 415, 35–44.

3. Rapp, D.; Englander-Golden, P., J. Chem. Phys. 1965, 43, 1464– 1479.

Speaker Biography:

Dr. Omar E. Rivera started working at the U.S. Food and Drug Administration in March 2023. His research currently focuses on identifying and characterizing extractables and leachables. Currently involved in developing ways of evaluating method performance for breath analysis. Dr. Rivera’s prior employment history has been working for the federal government as a contractor. For three years he worked with U.S. Customs and Border Protection aiding officers from out in the field to identify illicit narcotics substances that were smuggled to the country through different spectroscopic and chromatographic techniques. Started his career working at the Savannah River National Laboratory (SRNL) for the Non-proliferation technologies sections for five years. The group developed a series of devices that were tested in areas of suspected illegal weapons development.

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