Abstract
The rapid development of commercially available molecular assays in response to the COVID-19 pandemic has been essential in identifying positive cases and guiding state and national response plans. With over 200 SARS-CoV-2 molecular tests having received emergency use authorization by the US Food and Drug Administration, numerous studies have been conducted to evaluate these methods and compare their analytical and clinical performance. By applying the lessons learned from the rapid development of molecular assays in response to the COVID-19 pandemic, the diagnostic industry will be better prepared to respond to future outbreaks of novel infectious diseases.
Keywords: Analytical sensitivity; Analytical specificity; COVID-19; Clinical performance; Emergency use authorization; Molecular; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Emergency use authorization, molecular, analytical sensitivity, Clinical performance, Analytical specificity, 【초록키워드】 SARS-CoV-2, Diseases, COVID-19 pandemic, diagnostic, drug, outbreak, clinical, Molecular assay, food, Emergency, National, positive, molecular test, evaluate, conducted, respond, 【제목키워드】 coronavirus 2, clinical, respiratory, performance, Major, the United State,