Rapid Implementation of a SARS-CoV-2 Diagnostic qRT-PCR Test with Emergency Use Authorization at a Large Academic Safety-Net Hospital

Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is now a major global public health crisis. In the United States, significant delays in the rapid development and distribution of diagnostic testing for SARS-CoV-2 infection have prevented adequate COVID-19 patient care and public health management of the pandemic, impacting the timely mapping of the dynamics of viral spread in the general population, and more topically, the conservation of personal protective equipment. Furthermore, vulnerable populations such as those served by Boston Medical Center (BMC), the largest safety net hospital in New England, represent a high-risk group across multiple dimensions, including a higher prevalence of pre-existing conditions and substance use disorders, lower general health maintenance, unstable housing, and a propensity for rapid community spread, highlighting the urgent need for rapid and reliable in-house testing infrastructure.  Here, we report the rapid implementation of a SARS-CoV-2 diagnostic RT-PCR assay with Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).  Our test offers a more rapid turnaround time in comparison to currently available commercial or state laboratory facilities, and enables clinicians and patients to make more informed decisions with personal and public health ramifications. The template and protocol that we have generated and validated could be useful for other smaller community hospitals lacking capital intensive automated clinical laboratory machinery to run molecular biology assays.

Keywords: SARS-CoV-2, COVID-19, coronavirus, Pathology and Laboratory Medicine, Clinical Diagnostics, Emergency Use Authorization