Diagnostic Testing for COVID-19
In the weeks following the initial characterization of COVID-19, the Chinese and American Centers for Disease Control and Prevention (CDC) rapidly developed molecular assays for detection of the variant virus in clinical samples (1, 7). Other groups have also described the development of real-time PCR methods to diagnose COVID-19, mainly targeting various combinations of the open reading frame (Orf), envelope (E), nucleocapsid (N), and RNA-dependent RNA polymerase (RdRp) genes (8–10). On February 4, 2020, the United States Food and Drug Administration (FDA) took an important step, issuing an emergency use authorization for the US CDC’s COVID-19 real-time PCR assay, thereby enabling CDC-qualified laboratories to perform the test. Currently, there are 115 CDC-qualified laboratories in the US (i.e., state and local public health laboratories and Department of Defense laboratories), and 191 qualified laboratories worldwide. However, to date, clinical laboratories in the US have not had access to the CDC COVID-19 assay, leaving a gap in the ability of healthcare providers to rapidly diagnose and manage patients who present with a respiratory illness during this emerging outbreak.