Diagnostic Testing for the Novel Coronavirus
2020
This perspective provides insights about the controversies over diagnostic testing that have dominated U.S. headlines regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease-2019 (COVID-19).
The authors review early testing challenges, beginning with the initial technical problems with the first test developed by the Centers for Disease Control and Prevention (CDC), which left the U.S. with inadequate diagnostic capacity early in the epidemic. They discuss the "diagnostic testing gap" and explain how the COVID-testing issue highlights a controversial area of public policy: the regulation of laboratory-developed tests. They postulate that "while initial testing criteria were too narrow to monitor and control the spread of the disease, the sudden pivot to a far broader testing approach, could be an overcorrection."
It should be noted that this perspective was written in the relatively earlier stages of the epidemic. As a supplement to teaching materials, this perspective can provide students with a brief informative narrative to better understand how the regulatory structure for diagnostic tests in the U.S. interacts with public health emergencies.
Diagnostic Testing for the Novel Coronavirus
Source:
Sharfstein JM, Becker SJ, Mello MM. Diagnostic Testing for the Novel Coronavirus. JAMA 2020; 323 (15): 1437-1438. https://doi.org/10.1001/jama.2020.3864