Abstract
Faced with the COVID-19 pandemic, the US system for developing and testing technologies was challenged in unparalleled ways. This article describes the multi-institutional, transdisciplinary team of the “RADxSM Tech Test Verification Core” and its role in expediting evaluations of COVID-19 testing devices. Expertise related to aspects of diagnostic testing was coordinated to evaluate testing devices with the goal of significantly expanding the ability to mass screen Americans to preserve lives and facilitate the safe return to work and school. Focal points included: laboratory and clinical device evaluation of the limit of viral detection, sensitivity, and specificity of devices in controlled and community settings; regulatory expertise to provide focused attention to barriers to device approval and distribution; usability testing from the perspective of patients and those using the tests to identify and overcome device limitations, and engineering assessment to evaluate robustness of design including human factors, manufacturability, and scalability.
Highlights
The COVID-19 pandemic has presented unprecedented challenges including the critical need to efficiently develop accurate diagnostic tests to rapidly detect symptomatic and asymptomatic infections [1]–[3]
One approach to addressing this problem was to collect SARSCoV-2-positive nasopharyngeal swabs from the participating biorepositories, pool the samples, and freeze the resulting pool in single-use aliquots. This approach eliminated several problems: the results were not affected by inactivation methods, the matrix was one of the most commonly used for diagnostics, the exact same sample could be used for several different devices, the testing could be performed in the BSL-2 enhanced laboratory, and the aliquots were sufficiently concentrated that several 10-log dilutions could be performed to objectively compare sensitivity of assays to each other
While device test results from this initiative will be published in future papers, the process and experience of launching the Test Verification Core” (TVC) has been an instructive experience that warrants sharing to generalize the knowledge gained
Summary
The COVID-19 pandemic has presented unprecedented challenges including the critical need to efficiently develop accurate diagnostic tests to rapidly detect symptomatic and asymptomatic infections [1]–[3]. 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 While these sub cores were staffed to function as independent units, strong leadership oversight and a carefully designed communication strategy were implemented to coordinate and integrate their activities to generate a wellinformed, unified, multi-disciplinary, expert recommendation for each device that entered the TVC. Collaboration and support from administrative leadership at all the partner institutions (Emory, GT, Children’s) helped tremendously with multiple challenges such as identifying available and qualified research personnel, expediting Material Transfer and Data Use Agreements, IRB amendments, and troubleshooting subcontracting issues just to name a few
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