Browsing by keyword "Testing DOI creation, Testing DOI creation"

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    • The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech
      Robinson, Matthew L.; Gibson, Laura L.; McManus, David D. (2021-04-28)
      The NIH Rapid Acceleration of Diagnostics (RADx SM ) Tech Program was created to speed the development, validation, and commercialization of innovative point-of-care (POC) and home-based tests, and to improve clinical laboratory tests, that can directly detect SARS-CoV-2. Leveraging the experience of the Point-of-Care Technologies Research Network, a Clinical Review Committee (CRC) composed of clinicians, bioengineers, regulatory experts, and laboratorians was created to provide structured feedback to SARS-CoV-2 diagnostic innovators. The CRC convened 53 meetings with 49 companies offering SARS-CoV-2 tests in POC and reference laboratory formats as well as collection materials. The CRC identified common barriers to device design finalization including biosafety, workflow, result reporting, regulatory requirements, sample type, supply chain, limit of detection, lack of relevant validation data, and price-performance-use mismatch. Feedback from companies participating was positive.

    • The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies
      Gibson, Laura L.; Fahey, Nisha M.; Hafer, Nathaniel; Broach, John P.; Barton, Bruce A.; Lemon, Stephenie C.; Blodgett, Allison; McManus, David D. (2021-04-28)
      The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx SM ) Tech initiative to support the development and commercialization of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care test devices. The primary objective of the Clinical Studies Core (CSC) was to perform SARS-CoV-2 device studies involving diverse populations and settings. Within a few months, the infrastructure for clinical studies was developed, including a master protocol, digital study platform, data management system, single IRB, and multi-site partnerships. Data from some studies are being used to support Emergency Use Authorization of novel SARS-CoV-2 test devices. The CSC reduced the typical time and cost of developing medical devices and highlighted the impactful role of academic and NIH partnership in addressing public health needs at a rapid pace during a global pandemic. The structure, deployment, and lessons learned from this experience are widely applicable to future in vitro diagnostic device clinical studies.

    • Understanding Healthcare Professionals' Perspectives on Point-of-Care Testing
      Teebagy, Sean; Wang, Zi-Yue; Dunlap, Denise; Saleeba, Connor; DiMezza, Danielle; Crain, JoAnn; Lilly, Craig M.; Buchholz, Bryan; McManus, David D.; Hafer, Nathaniel S. (2022-02-19)
      Point-of-care testing (POCT) is an emerging technology that provides crucial assistance in delivering healthcare. The COVID-19 pandemic led to the accelerated importance of POCT technology due to its in-home accessibility. While POCT use and implementation has increased, little research has been published about how healthcare professionals perceive these technologies. The objective of our study was to examine the current perspectives of healthcare professionals towards POCT. We surveyed healthcare professionals to quantify perceptions of POCT usage, adoption, benefits, and concerns between October 2020 and November 2020. Questions regarding POCT perception were assessed on a 5-point Likert Scale. We received a total of 287 survey responses. Of the respondents, 53.7% were male, 66.6% were white, and 30.7% have been in practice for over 20 years. We found that the most supported benefit was POCTs ability to improve patient management (92%) and that the most supported concern was that POCTs lead to over-testing (30%). This study provides a better understanding of healthcare workers' perspectives on POCT. To improve patient outcomes through the usage of POCT, greater research is needed to assess the needs and concerns of industry and healthcare stakeholders.