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The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for
Eric Nehl1, Stacy Heilman2, David Ku3
1Behavioral, Social & Health Education SciencesEmory University Atlanta GA 30322-1007 USA.
IEEE Open Journal of Engineering in Medicine and Biology
|June 30, 2021
Summary
The RADx Tech Test Verification Core rapidly evaluated COVID-19 diagnostic tests. This expedited the availability of crucial screening tools, aiding public health responses and safe reopening efforts.
Area of Science:
- Biomedical Engineering
- Diagnostic Technology Evaluation
- Public Health Preparedness
Background:
- The COVID-19 pandemic presented unprecedented challenges to the US technology development and testing systems.
- A need existed to rapidly assess and scale diagnostic testing capabilities for effective public health interventions.
Purpose of the Study:
- To describe the formation and function of the RADx (Rapid Acceleration of Diagnostics) Tech Test Verification Core.
- To outline the coordinated, multi-institutional approach to expedite the evaluation of COVID-19 testing devices.
Main Methods:
- Coordinated expertise in diagnostic testing, regulatory affairs, usability, and engineering.
- Conducted laboratory and clinical evaluations assessing sensitivity, specificity, and limit of detection.
- Performed usability testing with patients and end-users, alongside engineering assessments for manufacturability and scalability.
Main Results:
- Successfully expedited the evaluation process for numerous COVID-19 testing technologies.
- Identified and addressed limitations in device performance, usability, and scalability.
- Facilitated the expansion of mass screening capabilities for the American population.
Conclusions:
- The RADx Tech Test Verification Core model proved effective in rapidly evaluating diagnostic technologies during a public health crisis.
- This coordinated approach was crucial for increasing testing capacity, supporting public health, and enabling societal reopening.
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