Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), 900 rue Saint-Denis, Montréal, QC H2X 0A9, Canada.
Department of Microbiology, Infectious Diseases and Immunology, Université de Montréal, Montréal, QC H3C 3J7, Canada.
Viruses. 2021 Sep 2;13(9):1752. doi: 10.3390/v13091752.
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.
为应对 COVID-19 大流行期间对诊断工具的需求呈指数级增长的空前且突然的情况,快速开发了替代标准植绒拭子的 3D 打印替代品。鉴于预期的短缺,我们机构实施了基于医院的 3D 打印平台,用于根据南佛罗里达大学健康放射学和 Northwell 健康系统团队向社区提供的免费、开源设计生产鼻咽和口咽采样用拭子,以替代当地使用的商业拭子。我们通过对 3D 打印的“Northwell 模型”与 cobas PCR Media 拭子样品试剂盒进行头对头诊断准确性研究,对 3D 打印拭子进行了验证。我们观察到 3D 打印拭子和植绒拭子的结果具有极好的一致性(总一致性为 96.8%,Kappa 值为 0.936),表明在植绒拭子短缺的情况下,内部 3D 打印拭子可以可靠地使用。据我们所知,这是第一项报告 3D 打印拭子自主医院生产和临床验证的研究。