![]() ![]() ![]() 1 In a scramble to develop diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) process to allow for more applicants to seek approval for tests. As infections rapidly spread, scientists struggled to develop and distribute reliable diagnostic tests and establish meaningful testing protocols. The 9 at-home tests currently available under EUAs show high positive percent agreement and negative percent agreement for identifying SARS-CoV-2.įeelings of being unprepared and overwhelmed rippled throughout the world in the early days of the coronavirus disease 2019 (COVID-19) pandemic.Nine diagnostic tests have been granted EUA for at-home use, including 3 molecular tests: Lucira coronavirus disease 2019 (COVID-19) all-in-one test kit, Lucira CHECK-IT COVID-19 test kit, and Cue COVID-19 test for home and over-the-counter (OTC) use and 6 antigen tests: BinaxNOW COVID-19 Ag card home test, BinaxNOW COVID-19 antigen self-test, BinaxNOW COVID-19 Ag card 2 home test, QuickVue at-home COVID-19 test, QuickVue at-home OTC COVID-19 test, and Ellume COVID-19 home test. ![]()
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