3D printer manufacturer EnvisionTEC (Dearborn, Mich.) announced today it has successfully completed a clinical trial to use its nasopharyngeal swabs for COVID-19 testing.
The company is encouraging its customers to register with the FDA so they can join in the effort to produce the desperately needed swabs.
EnvisionTEC engineers designed a collection tip for a flexible nasal swab that underwent several rigorous mechanical and chemical tests, according to the company. This was done to ensure that the swabs pick up viral RNA particles and do not interfere with PCA/reagents, that they are chemically safe, that they would bend 180 degrees without breaking, and that the design would be able to safely collect enough virus particles from the nasal passage to effectively test.
The swab continued to perform mechanically the same after being sterilized by steam at 270°F in an autoclave, according to EnvisionTEC. Other 3D-printed swabs have shown deterioration following autoclave procedures, the company added.
“Analytical results were positive, with a high level of concordance with the reference swab and with subjective results showing that [EnvisionTEC’s] swab performed neutrally or better than other test swabs,” said Dr. Ramy Arnaout, associate director of the clinical microbiology laboratories at Beth Israel Deaconess Medical Center in Boston, in a news release.
EnvisionTEC worked with Beth Israel Deaconess to develop a swab design and material to be printed on its Envision One cDLM 3D printer. Launched in early 2019, the Envision One cDLM 3D printer has been the company’s best-selling 3D printer to date, with more than 1000 units in use among dental labs, orthodontic practices, universities, medical device manufacturers and more.The printer is capable of producing up to 2400 swabs in 24 hours, the company noted.
EnvisionTEC said it is already taking orders and producing sterilized and unsterilized nasopharyngeal swabs for hospitals, healthcare providers, government agencies and the armed forces. Companies and organizations interested in printing the swabs must first be registered with the FDA and the swabs must be added to their medical device listing with the FDA. They must also own an Envision One cDLM 3D printer and a PCA 2000 curing unit.
EnvisionTEC was not able to provide the number of customers interested in producing the swabs, according to spokeswoman Jenna Franklin. The company has scheduled a meeting with interested customers for Friday, Franklin said.
More information on the initiative is available here.