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      Open Development and Clinical Validation Of Multiple 3D-Printed Sample-Collection Swabs: Rapid Resolution of a Critical COVID-19 Testing Bottleneck

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          Abstract

          The SARS-CoV-2 pandemic has caused a severe international shortage of the nasopharyngeal swabs that are required for collection of optimal specimens, creating a critical bottleneck in the way of high-sensitivity virological testing for COVID-19. To address this crisis, we designed and executed an innovative, radically cooperative, rapid-response translational-research program that brought together healthcare workers, manufacturers, and scientists to emergently develop and clinically validate new swabs for immediate mass production by 3D printing. We performed a rigorous multi-step preclinical evaluation on 160 swab designs and 48 materials from 24 companies, laboratories, and individuals, and shared results and other feedback 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 polymerase chain reaction (RT-PCR) results were compared. All prototypes displayed excellent concordance with the control (κ=0.85–0.89). Cycle-threshold (Ct) values were not significantly different between each prototype and the control, supporting the new swabs’ non-inferiority (Mann-Whitney U [MWU] p>0.05). Study staff preferred one of the prototypes over the others and 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.

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          On a Test of Whether one of Two Random Variables is Stochastically Larger than the Other

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            The nature of human altruism.

            Some of the most fundamental questions concerning our evolutionary origins, our social relations, and the organization of society are centred around issues of altruism and selfishness. Experimental evidence indicates that human altruism is a powerful force and is unique in the animal world. However, there is much individual heterogeneity and the interaction between altruists and selfish individuals is vital to human cooperation. Depending on the environment, a minority of altruists can force a majority of selfish individuals to cooperate or, conversely, a few egoists can induce a large number of altruists to defect. Current gene-based evolutionary theories cannot explain important patterns of human altruism, pointing towards the importance of both theories of cultural evolution as well as gene-culture co-evolution.
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              3D-printing techniques in a medical setting: a systematic literature review

              Background Three-dimensional (3D) printing has numerous applications and has gained much interest in the medical world. The constantly improving quality of 3D-printing applications has contributed to their increased use on patients. This paper summarizes the literature on surgical 3D-printing applications used on patients, with a focus on reported clinical and economic outcomes. Methods Three major literature databases were screened for case series (more than three cases described in the same study) and trials of surgical applications of 3D printing in humans. Results 227 surgical papers were analyzed and summarized using an evidence table. The papers described the use of 3D printing for surgical guides, anatomical models, and custom implants. 3D printing is used in multiple surgical domains, such as orthopedics, maxillofacial surgery, cranial surgery, and spinal surgery. In general, the advantages of 3D-printed parts are said to include reduced surgical time, improved medical outcome, and decreased radiation exposure. The costs of printing and additional scans generally increase the overall cost of the procedure. Conclusion 3D printing is well integrated in surgical practice and research. Applications vary from anatomical models mainly intended for surgical planning to surgical guides and implants. Our research suggests that there are several advantages to 3D-printed applications, but that further research is needed to determine whether the increased intervention costs can be balanced with the observable advantages of this new technology. There is a need for a formal cost–effectiveness analysis. Electronic supplementary material The online version of this article (doi:10.1186/s12938-016-0236-4) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                medRxiv
                MEDRXIV
                medRxiv
                Cold Spring Harbor Laboratory
                07 May 2020
                : 2020.04.14.20065094
                Affiliations
                [a ]Department of Radiology, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [b ]Clinical Microbiology Laboratories, Division of Clinical Pathology, Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA USA 02215
                [c ]Division of Infectious Disease, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [d ]Harvard Medical School, Boston, MA, USA 02115
                [e ]Division of Urologic Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [f ]Division of Respiratory Therapy, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [g ]Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [h ]Division of Perioperative Services, Department of Central Processing, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [i ]Division of Infection Control/Hospital Epidemiology, Silverman Institute for Healthcare Quality and Safety, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
                [j ]Division of Clinical Informatics, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA USA 02215
                Author notes
                []Corresponding author: +1-617-538-5681, rarnaout@ 123456bidmc.harvard.edu .
                Article
                10.1101/2020.04.14.20065094
                7273259
                32511491
                f0423ce0-b292-46c2-a872-bdabd20f2fbc

                This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License, which allows reusers to copy and distribute the material in any medium or format in unadapted form only, and only so long as attribution is given to the creator. The license allows for commercial use.

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