Chapter 8 - Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays

Summary

This chapter describes lab verification and clinical validation of tests for the detection of SARS-CoV-2. As new SARS-CoV-2 tests were being developed early in the pandemic, extensive lab verification studies to “test the tests” were conducted at ACME POCT at Emory University. Initial testing was performed in a Biosafety Level 3 facility to determine if the assays could detect propagated SARS-CoV-2 in ideal conditions and evaluate the specificity of these tests. We then describe the establishment of a Biorepository to bank SARS-CoV-2 variant samples and use these samples to determine whether tests could detect new variants with equal sensitivity as the original wild-type virus. This chapter also describes the clinical validation of tests using samples collected from individuals at testing centers. The clinical validation core requires careful planning for staffing and personnel training, semi-permanent and mobile clinical sites, defining inclusion and exclusion parameters, and data collection and reporting. Our experience demonstrated the importance of developing strong relationships with academic and private partners to facilitate clinical site setup, marketing, and purchasing.