This proposal seeks to expand upon breath analysis technology that is being actively studied as the focus of NIH grant #6R42DA049655-02 and leverage this technology for rapid COVID-19 diagnostics. There is a dire need for sensitive and specific diagnostic tests for COVID-19 that can be performed quickly. The differential mobility spectrometry (DMS) breath analysis technology currently under investigation for drug detection may be adapted to fill this void. During this supplement we will perform a biomarker discovery effort to determine the exhaled breath molecular species most suitable for use as a COVID-19 biomarker. Once a target species has been identified, methods of capture that can be implemented within the safety paradigm governing COVID-19 testing will be investigated. We will also initiate conversation with the FDA and develop an FDA approval strategy to expedite the deployment of a future breath based COVID-19 diagnostic instrument based upon the technology being studied under this administrative supplement?s parent grant.
The proposed administrative supplement consists of an effort to leverage the exhaled breath analysis technology, being investigated under the parent grant, for COVID-19 detection. The work proposed in this administrative supplement will identify exhaled breath biomarkers with promising potential for clinical use as a COVID-19 diagnostic. Once a biomarker target is identified we will investigate methods of trapping this molecular species suitable for enhanced biosafety as required for COVID-19 activities. Finally, we will initiate discussions with the FDA and develop an approach for obtaining FDA approval for a COVID-19 diagnostic technique based upon the microAnalyzer instrument being investigated under the parent grant.