Opinion: How to ensure regulations don’t stymie much-needed COVID-19 point-of-care testing

The coronavirus disease 2019 (COVID-19) pandemic has raged for more than a year in the United States, upending life as we knew it. Nevertheless, we have seen incredibly rapid advances in vaccines, therapeutics, and diagnostic testing technology. There is tremendous need and economic interest in reopening our businesses and schools and in resuming gatherings for entertainment and sporting events. To accomplish this, we need a strong multifaceted strategy. Already, widespread vaccination is well underway. But those efforts must be coupled with aggressive community-based COVID point-of-care testing so that any case of asymptomatic infection, especially in the most transmissible phase, is rapidly identified (1). We must devise more sensible regulations that meet the moment, allowing for rapid, widespread COVID-19 point-of-care testing. Image credit: Shutterstock/zstock. Corporate and federal support of medical diagnostic companies has fueled innovative, easy-to-use, inexpensive, point-of-care COVID-19 viral tests with multiple different technologies. The retail cost of these tests is now as low as $5 per unit, and they have become as easy to use as a home pregnancy test. Unfortunately, it’s not enough. The US Food and Drug Administration (FDA) has expedited the evaluation and granting of Emergency Use Authorizations (EUAs), ensuring that newly developed tests meeting validation criteria come to market promptly. However, similar to COVID vaccine distribution “last mile” barriers, there remain significant challenges to the real-world implementation of rapid, point-of-care testing. These remain despite the FDA, in July 2020, issuing an EUA application template for at-home and over-the-counter (OTC) tests for nonlab settings, such as homes, offices, or … [↵][1]1To whom correspondence may be addressed. Email: clare.rock{at}jhmi.edu. [1]: #xref-corresp-1-1