Dearborn’s EnvisionTEC, a global manufacturer of desktop and full-production 3-D printers and materials, has completed a clinical trial to use its 3-D printed nasopharyngeal swabs for COVID-19 testing.
The company and a growing number of its Envision One cDLM customers, all of which EnvisionTEC says have registered with the U.S. Food and Drug Administration, are working on the endeavor and will have the capability to produce up to 1 million swabs per day.
Test kit availability is inadequate for large-scale testing in the U.S. and around the world. The traditional manufacturing method for the swabs is tedious and limited, according to EnvisionTEC, with the final testing swab needed to exhibit unique properties of softness and flexibility that are difficult to produce. EnvisionTEC worked with Beth Israel Deaconess Medical Center in Boston to develop a swab design and material to be printed on its Envision One cDLM 3-D printer.
The printer is the company’s best seller, and more than 1,000 of these printers are used in dental labs, orthodontic practices, universities, medical device manufacturers, and more. Envision One is capable of making up to 2,400 swabs in 24 hours.
EnvisionTEC engineers have designed a collection tip for a flexible nasal swab that has completed testing in an institutional review board-approved clinical trial. The testing of the design and the material included mechanical and chemical tests to ensure the swabs work and are safe.
“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,” says Dr. Ramy Arnaout, associate director of the clinical microbiology laboratories at Beth Israel Deaconess Medical Center.
Those testing the product gave positive comments about the comfort, flexibility, and ease of insertion, which EnvisionTEC attributes to its E-Guide Soft material, a biomedically safe 3-D printing material.
EnvisionTEC is taking orders and producing sterilized and unsterilized swabs for hospitals, health care providers, government agencies, and armed forces. To place an order, email covid19@envisiontec.com.
The company was founded in 2002.
