Graduation Date

Fall 12-18-2020

Document Type

Dissertation

Degree Name

Doctor of Philosophy (PhD)

Programs

Medical Sciences Interdepartmental Area

First Advisor

Michael Wadman

Second Advisor

James McClay

Third Advisor

Jane Meza

Fourth Advisor

Deepak Khazanchi

Abstract

The SARS-CoV-2 virus outbreak has underscored numerous weak links in our biodefense countermeasures against highly communicable diseases. Many believe it was our lack of an effective testing model that allowed the virus to become a global pandemic within a short period. The gold standard collection method for the SARS-CoV-2 virus involves mechanical debridement of the nasopharyngeal cavity with a stiff swab applicator, which has been known to cause pain and injury to patients, subsequently resulting in low patient acceptance of the procedure. Due to the invasive nature of the nasopharyngeal swab collection method, it may not be conducive to the implementation of a mass or distance testing model. This dissertation attempted to develop an alternative specimen collection method for respiratory pathogens using a fluid debridement mechanism as opposed to the traditional mechanical swab debridement method. By adopting the design principles of design thinking, design control, and human factors engineering (HFE), this project was successful in developing a working prototype of the proposed concept. A pilot study was conducted to validate engineering parameters and the diagnostic validity of the study device. Data from the pilot study demonstrated the study device was successful in debriding the nasopharyngeal cavity for epithelial cells as confirmed by polymerase chain reaction (PCR) testing for the RNase P gene target. The study device had a 100% capture rate while maintaining consistently low cyclic threshold (CT) values indicating adequate specimen cellularity.

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