Role of clinical laboratories in response to the COVID-19 pandemic

摘要

The outbreak of COVID-19 (caused by SARS-CoV-2) is now a pandemic that has caused a global socio-economic disorder. Since its identification in the region of Wuhan, China, 2,629,579 confirmed cases with over 182,900 COVID-19 related deaths have been reported globally [ ]. In response to the outbreak, several state authorities and commercial companies have developed diagnostic assays to test individuals for the SARS-CoV-2 infection. Currently, over 40 diagnostic assays have received Emergency Use Authorization (EUA) from the Federal US FDA for COVID-19 testing. In the US, clinical laboratories are required to perform ‘bridging studies’ on FDA approved SARS-CoV-2 diagnostic assays to implement testing under the EUA regulation.