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  • Chapter 7 - Development of Assays to Diagnose COVID-19

  • Edited by Steven C. Schachter, Harvard Medical School, Wade E. Bolton, VentureWell/Rapid Acceleration of Diagnostics (RADx)
  • Book:
    Accelerating Diagnostics in a Time of Crisis
    Published online:
    06 January 2024
    Print publication:
    07 March 2024, pp 125-142

  • 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.