Blueprint for a Pop-up SARS-CoV-2 Testing Lab

Jennifer A. Doudna

To meet the clinical validity criterion, 95% of all SARS-CoV-2 RNA or virus-spiked samples must be positive, and 100% of all unspiked samples must be negative. As shown in Figure 4 , our LDT attains the required sensitivity and specificity. We further validated our assay and workflow by testing additional known positive and known negative samples from a different testing facility. These samples (generous gift of Jeffrey Shapiro, Kaiser Permanente), were originally assayed at the Kaiser Permanente CLIA laboratory using the Roche cobas® SARS-CoV-2 kit targeting ORF1ab and E genes (Fig. 1 ) on a Roche Cobas8000 testing system, and were provided to us deidentified and bearing no PHI. Specimens for testing in our facility were created from the Kaiser samples by transferring the sample in UTM into a new tube with equal volume of 2X DNA/RNA Shield in PBS (our sample collection buffer) in a BSL-3 facility on campus. Once inactivated, decontaminated, and released from the BSL-3 lab, these samples were then run through our workflow at the IGI ( Fig. 5 and Supplementary Fig. 3 ).