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 validation process for the swab consists 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 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. 

Print NP Swabs

These NP swabs are a Class 1 medical device.  In order to print these for use by medical professionals, you must first be registered with the FDA and the swabs must be added to your medical device listing with the FDA.

Click here for instructions regarding this registration and listing.

Once this is done, please email covid19@envisiontec.com in North America and the Caribbean to be added to the list of available manufacturing partners. The protocols being developed for the NP swabs require an Envision One cDLM and a PCA 2000 curing unit.

NP Swab FDA Listings

Applicator, Absorbent Tipped, Sterile, Product Code KXG

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2666

Applicator, Absorbent Tipped, Non-Sterile, Product Code KXF

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=2665