Analytical Validation of a COVID-19 qRT-PCR Detection Assay Using a 384-well Format and Three Extraction Methods

Andrew C Nelson; Benjamin Auch; Matthew Schomaker; Daryl M Gohl; Patrick Grady; Darrell Johnson; Robyn Kincaid; Kylene E Karnuth; Jerry Daniel; Jessica K Fiege; Elizabeth J Fay; Tyler Bold; Ryan A Langlois; Kenneth B Beckman; Sophia Yohe

Given the immense scale of the COVID-19 pandemic, it is predicted that reagent shortages for testing will be a continuous problem [6] . The ability of high-complexity, College of American Pathologist/CLIA88 compliant laboratories to rapidly and reliably adapt locally developed and validated testing procedures will play a key role in the United States' ability to confront this clinical need. Other groups have recently provided important data on the relative performance of different primer/probe sets for SARS-CoV2 [4, 7] . Intriguingly, Bruce et al. [8] provide data indicating that qRT-PCR detection of SARS-CoV2 could be successful on nasopharyngeal swab samples without any prior RNA extraction, at least as a screening mechanism. Innovative, rapid, and robust development and validation of new laboratory developed procedures will be required to help address the COVID-19 pandemic. In this setting, our work provides a blueprint for rapid characterization of new assay components and approaches as future supply chain shortages emerge. n/a n/a n/a n/a 31.6 31.8 NEG2 n/a n/a n/a n/a 27.1 27.3