Open Development and Clinical Validation of Multiple 3D-Printed Nasopharyngeal Collection Swabs: Rapid Resolution of a Critical COVID-19 Testing Bottleneck
Open Development and Clinical Validation of Multiple 3D-Printed Nasopharyngeal Collection Swabs: Rapid Resolution of a Critical COVID-19 Testing Bottleneck
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DOI：
10.1128/jcm.00876-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Arnaout, Ramy A.
中科院分区：
文献类型：
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作者：
Callahan, Cody J.;Lee, Rose;Arnaout, Ramy A.
由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的大流行导致国际上严重缺乏收集最佳标本所需的鼻咽拭子，这造成了一个严重的瓶颈，阻碍了临床实验室对SARS-CoV-2进行高敏感性病毒学测试的能力。为了应对这一危机，我们设计并执行了一个创新、合作、快速反应的转化研究计划，将医疗工作者、制造商和科学家聚集在一起，紧急开发并临床验证新的棉签，以便通过3D打印立即大规模生产。我们对来自24家公司、实验室和个人的160种棉签设计和48种材料进行了多步骤临床前评估，并通过公共数据存储库(http://github.com/rarnaout/Covidswab/).)共享结果和其他反馈我们通过机构审查委员会(IRB)批准的临床试验验证了四个原型，该试验涉及276名门诊志愿者，他们出现了疑似新冠肺炎的症状。每个参与者都用参考棉签(对照)和原型拭子拭子，并比较SARS-CoV-2逆转录酶聚合酶链式反应(RT-PCR)结果。所有样机与对照均表现出良好的一致性(kappa=0.85~0.89)。周期阈值(C-T)值在每个原型和对照之间没有显著差异，支持新拭子的非劣势(Mann-Whitney U[MWU]检验，P&gT；0.05)。研究人员更喜欢其中一个原型，总体上更喜欢对照棉签。从发现问题到验证第一个原型的总时间为22天。有关订购的联系信息，请访问http://printedswabs.org。我们的经验为快速开发、验证和部署应对这场大流行及以后的新技术提供了经验教训。
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a severe international shortage of the nasopharyngeal swabs that are required for collection of optimal specimens, creating a critical bottleneck blocking clinical laboratories' ability to perform high-sensitivity virological testing for SARS-CoV-2. To address this crisis, we designed and executed an innovative, cooperative, rapid-response translational-research program that brought together health care workers, manufacturers, and scientists to emergently develop and clinically validate new swabs for immediate mass production by 3D printing. We performed a multistep preclinical evaluation of 160 swab designs and 48 materials from 24 companies, laboratories, and individuals, and we shared results and other feed- back via a public data repository (http://github.com/rarnaout/Covidswab/). We validated four prototypes through an institutional review board (IRB)-approved clinical trial that involved 276 outpatient volunteers who presented to our hospital's drive-through testing center with symptoms suspicious for COVID-19. Each participant was swabbed with a reference swab (the control) and a prototype, and SARS-CoV-2 reverse transcriptase PCR (RT-PCR) results were compared. All prototypes displayed excellent concordance with the control (kappa = 0.85 to 0.89). Cycle threshold (C-T) values were not significantly different between each prototype and the control, supporting the new swabs' noninferiority (Mann-Whitney U [MWU] test, P> 0.05). Study staff preferred one of the prototypes over the others and preferred the control swab overall. The total time elapsed between identification of the problem and validation of the first prototype was 22 days. Contact information for ordering can be found at http://printedswabs.org . Our experience holds lessons for the rapid development, validation, and deployment of new technology for this pandemic and beyond.