Perhaps the biggest immediate need in the fight against COVID-19 is simply identifying those who have been infected as early as possible. Testing kit availability has been vastly inadequate, and the medical community has been working tirelessly with the 3D printing community to find a solution to mass-producing the nasopharyngeal collection swabs to alleviate the shortage quickly. EnvisionTEC has been working closely with the Harvard Microbiology Lab within a larger group dedicated to connecting academia with the manufacturing industry to combat this shortage.
To this end, EnvisionTEC engineers have designed a collection tip for a flexible nasal swab. Brian Nilson, of Nilson Laboratories, 3D printed the final design for testing. He was able to print 400 of the swabs in E-Guide Soft material on his Envision One cDLM in two hours. The testing process is comprised of a ten stage mechanical testing, a two part absorption test, a biological/chemical testing procedure to ensure the swab absorbs viral RNA particles and does not interfere with PCA/reagents, and a sample collection testing procedure. To pass, a sample needed to use a material that is approved as chemically safe, would bend 180 degrees without breaking, and the design needed to be able to safely collect enough virus particles from the nasal passage to effectively test.
E-Guide Soft has passed some of these tests and is awaiting final IRB testing and approval. Under FDA regulations, an IRB group that has been formally designated to review and monitor biomedical research involving human subjects has the authority to determine that E-Guide Soft is suitable for the mass production of the NP swabs for COVID-19 testing. EnvisionTEC has been working with Beth Israel Deaconess Medical Center (BIDMC) of Boston’s Biomedical Laboratory, to obtain the IRB approval. EnvisionTEC has long been committed to providing solutions to their customers and is now preparing to take on the call to action of helping to equip medical professionals with the tools needed to help combat this global pandemic. With a vast network of thousands of customers eager to help, EnvisionTEC is proud to offer the capability of producing quantities of up to half a million of the swab per day.