Clinical Evaluation of In-House-Produced 3D-Printed Nasopharyngeal Swabs for COVID-19 Testing

Grandjean Lapierre, Simon; Bedwani, Stéphane; DeBlois, François; Fortin, Audray; Zamorano Cuervo, Natalia; Zerouali, Karim; Caron, Elise; Morency-Potvin, Philippe; Gagnon, Simon; Nguissan, Nakome; Arlotto, Pascale; Hardy, Isabelle; Boutin, Catherine-Audrey; Tremblay, Cécile; Coutlée, François; de Guise, Jacques; Grandvaux, Nathalie

3D-printed alternatives to standard flocked swabs were rapidly developed to provide a response to the unprecedented and sudden need for an exponentially growing amount of diagnostic tools to fight the COVID-19 pandemic. In light of the anticipated shortage, a hospital-based 3D-printing platform was implemented in our institution for the production of swabs for nasopharyngeal and oropharyngeal sampling based on the freely available, open-source design provided to the community by University of South Florida’s Health Radiology and Northwell Health System teams as a replacement for locally used commercial swabs. Validation of our 3D-printed swabs was performed with a head-to-head diagnostic accuracy study of the 3D-printed “Northwell model” with the cobas PCR Media(®) swab sample kit. We observed an excellent concordance (total agreement 96.8%, Kappa 0.936) in results obtained with the 3D-printed and flocked swabs, indicating that the in-house 3D-printed swab could be used reliably in the context of a shortage of flocked swabs. To our knowledge, this is the first study to report on autonomous hospital-based production and clinical validation of 3D-printed swabs.