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

对内部生产的 3D 打印鼻咽拭子进行 COVID-19 检测的临床评估

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

Abstract

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.

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