Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19

摘要

Coronavirus disease 2019 (COVID-19), declared a pandemic by the WHO on 11 March 2020 (1), requires an early diagnosis to optimize patient management and limit further transmission. Currently, the gold standard and most commonly used diagnostic method in clinical microbiology laboratories is real-time PCR (RT-PCR) detecting the viral RNA in nasopharyngeal specimens (2). However, RT-PCR requires specialized instruments and personnel. In contrast, rapid antigen (Ag) detection (RAD) tests, which are widely used to diagnose viral diseases other than COVID-19, not only are rapid (15 to 30 min) but are less laborious and require only a comparatively short training period. However, to date, several commercialized RAD tests have been evaluated and most have demonstrated a lack of sensitivity (see Table S1 in the supplemental material).