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临床评估自制 3D 打印鼻咽拭子用于 COVID-19 检测。

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

机构信息

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.

出版信息

Viruses. 2021 Sep 2;13(9):1752. doi: 10.3390/v13091752.

DOI:10.3390/v13091752
PMID:34578334
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8473445/
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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/4147f03789b3/viruses-13-01752-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/80d8dbdb8642/viruses-13-01752-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/be37fcd5a618/viruses-13-01752-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/4147f03789b3/viruses-13-01752-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/80d8dbdb8642/viruses-13-01752-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/be37fcd5a618/viruses-13-01752-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f2d/8473445/4147f03789b3/viruses-13-01752-g003.jpg

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本文引用的文献

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The global rise of 3D printing during the COVID-19 pandemic.3D打印在新冠疫情期间的全球兴起。
Nat Rev Mater. 2020;5(9):637-639. doi: 10.1038/s41578-020-00234-3. Epub 2020 Aug 12.
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New SARS-CoV-2 Variants - Clinical, Public Health, and Vaccine Implications.新型严重急性呼吸综合征冠状病毒2变体——对临床、公共卫生及疫苗的影响
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用于检测SARS-CoV-2的3D打印拭子在成人和儿童中的临床验证。
Biol Methods Protoc. 2023 Jun 7;8(1):bpad009. doi: 10.1093/biomethods/bpad009. eCollection 2023.
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CFD based analysis of 3D printed nasopharyngeal swabs for COVID-19 diagnostics.基于 CFD 的用于 COVID-19 诊断的 3D 打印鼻咽拭子分析。
Comput Methods Programs Biomed. 2022 Aug;223:106977. doi: 10.1016/j.cmpb.2022.106977. Epub 2022 Jun 27.
Lancet. 2021 Feb 6;397(10273):452-455. doi: 10.1016/S0140-6736(21)00183-5. Epub 2021 Jan 27.
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Prospective clinical validation of 3D printed nasopharyngeal swabs for diagnosis of COVID-19.前瞻性临床验证 3D 打印鼻咽拭子用于 COVID-19 诊断。
Diagn Microbiol Infect Dis. 2021 Mar;99(3):115257. doi: 10.1016/j.diagmicrobio.2020.115257. Epub 2020 Oct 22.
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3D Printing in Medicine: Coronavirus Disease 2019 Testing With 3D Printed Nasopharyngeal Swabs.医学中的3D打印:使用3D打印鼻咽拭子进行2019冠状病毒病检测
Clin Infect Dis. 2021 Nov 2;73(9):e3033-e3035. doi: 10.1093/cid/ciaa1437.
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Comparison of SARS-CoV-2 detection from combined nasopharyngeal/oropharyngeal swab samples by a laboratory-developed real-time RT-PCR test and the Roche SARS-CoV-2 assay on a cobas 8800 instrument.比较实验室开发的实时 RT-PCR 检测与罗氏 cobas 8800 仪器上的 SARS-CoV-2 检测试剂盒对鼻咽/口咽联合拭子样本中 SARS-CoV-2 的检测。
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