Critical Aspects of SARS-CoV-2 Testing During the Pandemic

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is the causative agent of Coronavirus disease 2019 (COVID-19) [1]. This virus, from its humble beginnings in Wuhan, China, has since spread throughout the globe to become an international pandemic [2,3]. The impact of this pandemic has led to both critical supply shortages and an urgent need for tests and interventions before the usual full regulatory review by the Food and Drug Administration (FDA) [2,4 and 5]. These supply shortages have impacted the supply of critical materials and reagents for testing, such as personal protective equipment, viral transport media, swabs, and test reagents [4-6]. Concomitant with the supply shortages, that can truly hamper even the collection of specimens, is the issue that the pandemic can also lead to staffing shortages because staff members who are infected or exposed may need to quarantine [2,3]. The urgency in the need for tests has led the FDA to issue emergency use authorizations (EUA) for SARS-CoV-2 test assays [7]. The exclusive presence of only several EUA assays for SARS-CoV-2 testing represents a unique situation for the laboratorian as this pandemic is likely to be both the first and only time that a test with a EUA is run in his/her career. Effectively, the pandemic has created a new frontier of many tests under a EUA instead of having any test under full regulatory FDA approval.

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Author: Jeffrey Petersen

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