Department of Clinical Microbiology, OLVG Lab BV, Amsterdam, The Netherlands.
Department of Donor Medicine Research, Laboratory of Blood-borne Infections, Sanquin Research, Amsterdam, The Netherlands.
Microbiol Spectr. 2021 Dec 22;9(3):e0088421. doi: 10.1128/Spectrum.00884-21. Epub 2021 Nov 24.
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. 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.
本研究评估了 PanBio COVID-19 抗原（Ag）检测在医院感染控制政策中的性能。当医院工作人员出现与 SARS-CoV-2 相关的症状时，鼓励他们进行 COVID-19 检测。在大约 5 个月的时间里，Ag 检测的性能稳步下降，这在流行病学上与荷兰 SARS-CoV-2 B.1.1.7（alpha）变体的出现相吻合。这导致了一个假设，即 PanBio COVID-19 Ag 检测的诊断性能受到感染病毒变体的影响。结果表明，与感染非 B.1.1.7 变体的人相比，感染 SARS-CoV-2 B.1.1.7（alpha）变体的人 PanBio COVID-19 Ag 检测的敏感性显著降低，即使在调整病毒载量后也是如此。 COVID-19 的抗原检测被广泛用于快速识别 COVID-19 病例，例如，用于进入学校、节日和旅行。市场上有几种经过 FDA 和 CE 认证的检测方法。它们的性能主要是基于引起病毒的经典变体，即 SARS-CoV-2 的感染来评估的。本文提供的证据表明，最广泛使用的抗原检测之一对 COVID-19 的 alpha 变体的检测性能明显低于 SARS-CoV-2 的经典变体。这意味着在 SARS-CoV-2 的其他变体占主导地位的地区，需要重新评估抗原检测的作用。
