In a manner similar to the flu, infection with COVID-19 is diagnosed via the collection of virus material with a nasopharyngeal swab. With a nasal swab test, a long stick with a soft brush on the end is inserted into the nasal cavity and twirled around. The soft bristles of the swab collect a sample of secretions for analysis along the entire passageway that connects the base of the nose to the back of the throat. At the height of COVID-19 testing, in addition to personal protective equipment (PPE) like masks, gowns, and face shields, nasal swabs were in short supply. With the gold-standard nasal swab manufacturers either overseas or across the country, and already running at full capacity, it became apparent nasopharyngeal swabs were another product to be supplemented through Cleveland Clinic’s MAKE efforts.
But not just any swab would qualify for COVID-19 testing. Said Tom Kadavy, Senior Director, Product Development, and project lead for nasal swabs, “there’s more to them than meets the eye.” The gold-standard swabs used for virus testing are “flocked,” possessing a highly-engineered “bushy” end. Formally defined as the process by which many small fibers are electrostatically deposited onto a surface, flocking has an effect on sample quality and diagnostic accuracy of COVID-19 tests. The way the fibers are placed on the end of the product influences its ability to collect, hold onto, and elute samples into the testing transport media. Though an unusual manufacturing process, flocking has been around for some time in various industries. Its application to swabs, however, is unique and less pursued.
Containing two parts – the shaft and the flocked end – Kadavy started his pursuit of alternative swab production sourcing partners with injection molding abilities. Connecting with Cincinnati-based P&G iMFLUX, Kadavy was able to secure a donation of the tooling for an injection mold that would produce 50 swab shafts every 15 seconds. Working hours on end to create this critical production tooling, P&G completed what would be a 14-week effort in a mere two. Flocking ability to complete the swabs, however, remained a mystery until Product Development Manager, Frank Proch found Wisconsin-based Microbrush International. A specialty manufacturer of dental brushes, Microbrush possessed the machinery required to properly flock the molded swab shaft. Moving forward as a trio, Cleveland Clinic, P&G, and Microbrush produced prototypes with inspiring speed.
Cleveland Clinic supported Microbrush’s prototype test program with initial testing of the swab’s ability to collect cells from the inside of the cheek. This testing was completed by Belinda Yen-Lieberman and her advanced projects team and was a critical go/no-go hurdle for the project. Cleveland Clinic supported further testing at an outside lab location, successfully verifying collection efficiency using deactivated COVID-19 virus in a contrived sample matrix. On July 1, the Microbrush Test Swabs were FDA-listed and are now available for immediate purchase. From this endeavor, Cleveland Clinic received a donation of 63,000 swabs for its inventory, but the benefit of the project reaches far beyond Northeast Ohio. Says Kadavy, “The best thing about this project is that the volumes that can be made far exceed [Cleveland Clinic’s] needs. [Microbrush] should be able to alleviate some supply chain issues across the country with their additional capacity.”
Read Microbrush's release on PR Newswire.