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Implementing U.S. Covid-19 Testing: Regulatory and Infrastructural Challenges
Kesselheim, Aaron
Kesselheim, Aaron
Abstract
As COVID-19 cases continue to surge worldwide, more evidence is pointing towards asymptomatic transmission being a key driver of new infections, with studies showing it accounts for 17.9 to 30.8% of all infections. Regions that have managed to contain the virus have relied on social distancing and aggressive efforts to test as many people as possible. Unfortunately, delays in COVID-19 testing authorization and roll-out in the United States significantly hampered the country’s response to the pandemic. Within the first four months of the pandemic, only around 125 people per million had been tested in the US, in comparison to 5000+ people per million in South Korea. Although testing rates have improved since then, this initial lag in detection contributed to accelerated viral spread.
There were a few important reasons for the delays and challenges in the roll-out of COVID-19 testing in the United States. While FDA’s Emergency Use Authorization (EUA) protocol was created for such public health emergencies, this unprecedented pandemic has revealed weaknesses in both the administrative process and the national testing infrastructure. This article draws potential lessons from other countries in how to optimize the process of reviewing and disseminating diagnostic testing in a public health crisis.