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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Abstract
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.
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SciScore for 10.1101/2020.04.14.20065094: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: We involved representatives of our institution’s nursing, legal, intellectual property, leadership, purchasing, human resources, communications, and contracting teams and the institutional review board early and often in order to facilitate open development, reassign idled staff to our process, and minimize lead times during the rapidly changing situation. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources We took high-resolution photographs of all prototypes and stored Phase I results in a Microsoft Excel (Microsoft Corporation, … SciScore for 10.1101/2020.04.14.20065094: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: We involved representatives of our institution’s nursing, legal, intellectual property, leadership, purchasing, human resources, communications, and contracting teams and the institutional review board early and often in order to facilitate open development, reassign idled staff to our process, and minimize lead times during the rapidly changing situation. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources We took high-resolution photographs of all prototypes and stored Phase I results in a Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) spreadsheet that remains publicly available in the repository. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: Thank you for sharing your code and data.
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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