Point-of-Care Technology Research Network: An evolving model for collaborative translational research in biomedical engineering

The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies

“…First established in 2009 by NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB) and now supported by multiple NIH Institutes and Offices lead by NIBIB, the Point-of-Care Technologies Research Network (POCTRN) was well-positioned to apply its mission to drive the development of point-of-care diagnostics in the context of the SARS-CoV-2 pandemic [21] . The RADx Tech CSC was developed by the Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases, a POCTRN technology hub and an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell (UML) and Medical School (UMMS) campuses [22] .…”

The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change

“…Already well established prior to the pandemic, POCTRN uses a partnership model to improve clinical care through exploratory development of point-of-care test (POCT) devices, clinical needs assessment, training of technology developers, clinical testing, and the provision of administrative support [4] – [6] . The device verification needs for RADx Tech were quickly met by leveraging the academic and medical partners within one of the National Institute of Biomedical Imaging and Bioengineering (NIBIB)'s funded POCTRN centers, the Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT) [7] . Established in 2018, ACME POCT is a partnership between Emory University (Emory), Georgia Institute of Technology (GT), and Children's Healthcare of Atlanta (Children's).…”

“…The already established ACME POCT ( Fig. 1(a) ) was well positioned to assume the TVC responsibility, as the pre-COVID goal of the ACME POCT was to assist microsystems-based POC technology inventors from across the country by providing clinical needs assessments, clinical testing and validation, and technology refinement, with the objective of accelerating the path through translation, regulatory compliance, manufacturing, and clinical adoption [7] , [9] . Receipt of a supplement from NIBIB in May 2020 launched this new TVC directive by quickly redirecting the existing ACME POCT goals, processes, and personnel to pivot the focus to verification of the performance of COVID-19 diagnostic tests including sensitivity, specificity, limit of detection (LOD), and cross-reactivity with other viruses.…”

“…Device verification requires a wide variety of expertise and technical skillsets, and to be done well, must be conducted in a coordinated and integrated manner that is highly dependent upon strong communication and collaboration [4] , [7] . Below are descriptions of the key functions of the TVC including 1) Leadership & Administrative including evaluation and education functions; 2) Engineering Design and Human Factors; 3) Clinical/Translational Validation including virology, clinical population testing and sample collection and clinical laboratory assessment; 4) Regulatory.…”

Future potential of Rapid Acceleration of Diagnostics (RADx Tech) in molecular diagnostics

“…The RADx Tech program leveraged the Point-of-Care Technology Research Network (POCTRN) of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which has accelerated the clinical and commercial development of POC diagnostics since 2007 [3,4]. In addition to funding pilot projects, POCTRN Centers also provide experts in clinical and user input, commercialization advice, and access to clinical specimens.…”