CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours, but no more than 36 hours, between tests. This test is authorized for nonprescription home use with self-collected direct anterior nares specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals who are two years old or older.
The company also received an EUA for screening use with serial testing for its Sofia SARS Antigen FIA for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or are individuals without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two or three days—at least 24 hours but no more than 36—between tests. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate-, high-, or waived-complexity tests. The test is authorized for use at the point of care.