ABSTRACT This study evaluates the performance of the PanBio COVID-19 antigen (Ag) test as part of a hospital infection control policy. Hospital staff was encouraged to get tested for COVID-19 when presenting with SARS-CoV-2-related symptoms. In a period of approximately 5 months, a steady decline in the performance of the Ag test was noted, epidemiologically coinciding with the rise of the SARS-CoV-2 B.1.1.7 (alpha) variant of concern (VOC) in the Netherlands. This led to the hypothesis that the diagnostic performance of the PanBio COVID-19 Ag test was influenced by the infecting viral variant. The results show a significantly lower sensitivity of the PanBio COVID-19 Ag test in persons infected with the B.1.1.7 (alpha) variant of SARS-CoV-2 in comparison with that in persons infected with non-B.1.1.7 variants, also after adjustment for viral load. IMPORTANCE Antigen tests for COVID-19 are widely used for rapid identification of COVID-19 cases, for example, for access to schools, festivals, and travel. There are several FDA- and CE-cleared tests on the market. Their performance has been evaluated mainly on the basis of infections by the classical variant of the causing virus, SARS-CoV-2. This paper provides evidence that the performance of one of the most widely used antigen tests detects significantly fewer cases of COVID-19 by the alpha variant than by the classical variants of SARS-CoV-2. This means that the role of antigen tests needs to be reevaluated in regions where other variants of SARS-CoV-2 predominate.
【저자키워드】 COVID-19, SARS-CoV-2, diagnostics, Antigen, B.1.1.7 variant, 【초록키워드】 infection control, VoC, hospital, variant, Infection, diagnostic, FDA, virus, Symptoms, variants, Hospital staff, sensitivity, Schools, Region, Viral, Viral load, B.1.1.7, antigen test, Travel, Alpha, antigen tests, Alpha variant, viral variant, Evidence, Hypothesis, COVID-19 cases, Netherlands, (alpha, Hospital infection control, market, significantly lower, infecting, variants of SARS-CoV-2, variant of SARS-CoV-2, tested, classical, detect, evaluate, example, significantly, evaluated, provide, epidemiologically, presenting, other variant, the SARS-CoV-2, 【제목키워드】 Test, performance, SARS-CoV-2 B.1.1.7,