Accelerating Diagnostics in a Time of Crisis The Response to COVID-19 and a Roadmap for Future Pandemics
Book contents
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
- References
Chapter 7 - Development of Assays to Diagnose COVID-19
Published online by Cambridge University Press: 06 January 2024
Book contents
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
- References
Summary
This chapter covers the development of diagnostic tests that detect and often amplify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids (molecular tests) or directly detect protein antigens (antigen tests). In the Rapid Acceleration of Diagnostics (RADx®) Tech program, tests that could be performed by following the instructions for use (Clinical Laboratory Improvement Amendments-waived point-of-care tests) or at home (over the counter) became more ubiquitous and represented a paradigm shift in infectious disease diagnostics away from reference laboratory testing by trained laboratorians. Understanding the clinical use case and unmet need is essential to the development of successfully commercialized tests. Important considerations include sample type and collection, the timing of testing (asymptomatic, contact of a known case, or symptomatic), biosafety, the limit of detection and sensitivity, specificity, the turnaround time, form factor and workflow, internal controls, early verification and validation, and supply chain bottlenecks.
Keywords
- Type
- Chapter
- Information
- Accelerating Diagnostics in a Time of CrisisThe Response to COVID-19 and a Roadmap for Future Pandemics, pp. 125 - 142Publisher: Cambridge University PressPrint publication year: 2024
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