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

Jennifer A. Doudna

Here we provide a description of our path to establishing the IGI SARS-CoV-2 Diagnostic Testing Laboratory and the development and validation of a SARS-CoV-2 diagnostic test. Our RT-qPCR-based test shows a reproducible limit of detection of 1 x 10 3 viral genomic copies/ml, comparing favorably to other validated tests in current use for community testing. We encountered several bottlenecks to converting an academic research laboratory into a clinical diagnostic testing facility, and we share our experience here to help others with this process. First and foremost, the laboratory must ensure that it meets the regulatory requirements for infrastructure and staff, including CLIA certification, HIPAA compliance, and FDA authorization. In our experience, extending the license from an existing CLIA certified and licensed facility, using online HIPAA training and adapting a commercially available FDA certified test for use with our equipment saved time and resources. In addition, we managed supply chain bottlenecks by using donated equipment, reducing the test-sample volume used in our assay, adopting in-house sample barcoding, and adapting materials such as sampling tubes to work with available equipment. To identify local sources of PPE, we posted a call for masks, gloves, and gowns on our website and succeeded in locating sufficient supplies for personnel use during the planned weeks of operation. Lab and supporting personnel were assigned to work in shifts and a succession plan is in place to ensure uninterrupted operation. In our experience, patient sample collection is the rate-limiting step in our sample analysis pipeline. We continue to address challenges of interfacing with health centers for patient sample intake and we will soon implement a web portal for this purpose that will be described in a future update to this manuscript.