There is a nationwide shortage of the nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians have designed and tested their own swabs to produce as quickly and safely as possible.
These NP swabs were created by the University of South Florida and Norwell Health and are produced on FormLabs Form2 printers using Surgical Guide Resin. These NP Swabs are able to sterilized through autoclave prior to use.
NP swabs are flexible sticks with a bristled end that are inserted into the nose to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles. The swab is then placed into a vial that contains a culture medium. Swab sticks have an intentionally weak point 7–8 cm from the bristled tip, which allows the stick to be broken to the correct length so that the vial can be capped before it is transported to a laboratory for testing.
These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians are beginning to design and test their own swabs as quickly and safely as possible.
After identifying that nasal swabs for testing COVID-19 were in high demand and extremely limited in supply, a team from the USF Health’s 3D Clinical Applications Division created an initial design, working with Northwell Health and collaborating with Formlabs to develop prototypes and secure materials for a 3D printed alternative. Over the span of one week, the teams worked together to develop a nasal swab prototype and test it in the USF Health and Northwell Health labs. In two days, USF Health and Northwell Health developed prototypes using Formlabs’ 3D printers and biocompatible, autoclavable resins. The swabs were tested by clinicians at Northwell Health, USF Health and Tampa General Hospital for patient safety and comfort. Now that clinical validation is complete, 3D printers at USF Health and Northwell Health will produce the swabs and provide them to their patients.
The nasal swabs have cleared all testing hurdles and are now being produced. Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day, and leeching), and rapid clinical testing at Northwell Health and Tampa General Hospital. All testing showed that the 3D printed nasal swabs perform equally to standard swabs used for testing for COVID-19.
These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. Formlabs will produce swabs in its FDA-registered, ISO 13485 certified facility in the United States.