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

Jennifer A. Doudna

Our decision to make modifications to the Thermo Fisher workstream was rooted in a desire to increase testing throughput, reduce cost, ensure safety of our volunteers, and make use of existing and donated equipment. To increase throughput, we are implementing multiple automated liquid handlers and using qPCR machines with increased capacity. To reduce cost and to protect against supply chain pressure, we tested and validated the use of Thermo Fisher's RNA extraction and qPCR protocols at half the suggested reaction volumes (discussed in Reduced Reaction Volumes further on). To ensure the safety of our volunteers, we substituted the standard patient sample universal transport medium (UTM) for a virus-inactivating buffer (discussed in the Sample Collection section). With these modifications to the Thermo Fisher protocol, our LDT was developed and validated within the CLIA framework, and notice of the validation will be submitted to the FDA as a bridging study to the original EUA awarded to Thermo Fisher within the 15 day window specified by law.