Department of Microbiology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
J Clin Virol. 2021 Apr;137:104789. doi: 10.1016/j.jcv.2021.104789. Epub 2021 Mar 10.
Rapid antigen tests (RATs) may be included in national strategies for handling the SARS-CoV-2 pandemic, as they provide test results rapidly, are easily performed outside laboratories, and enable immediate contract tracing. However, before implementation further clinical evaluation of test sensitivity is warranted.
To examine the performance of Abbott's Panbio™ COVID-19 Ag Rapid Test Device for SARS-CoV-2 testing in a low to medium prevalence setting in Norway.
A prospective study comparing the results of the Panbio RAT with PCR in 4857 parallel samples collected at a SARS-CoV-2 test station in Oslo, and from COVID-19 outbreaks in six Norwegian municipalities.
A total of 4857 cases were included in the study; 3991 and 866 cases from the test station and the outbreak municipalities, respectively. The prevalence at the test station in Oslo was 6.3 %, and the overall sensitivity of the RAT was 74 %. Increased sensitivity was observed in patients who experienced symptoms (79 %) and when considering samples with viral loads above estimated level of infectivity (84 %), while it was lower in asymptomatic persons (55 %). In the outbreak municipalities, the overall prevalence was 6.9 %, and the total sensitivity of the RAT was 70 %.
Our results indicate that the test correctly identified most infectious individuals. Nevertheless, the sensitivity is considerably lower than for PCR, and it is important that the limitations of the test are kept in mind in the follow-up of tested individuals.
快速抗原检测（RAT）可能被纳入国家处理 SARS-CoV-2 大流行的策略，因为它们能快速提供检测结果，在实验室外易于操作，并且能够立即进行接触者追踪。然而，在实施之前，进一步的临床评估是有必要的。
在挪威的低至中度流行环境下，评估 Abbott 的 Panbio™ COVID-19 Ag 快速检测设备用于 SARS-CoV-2 检测的性能。
一项前瞻性研究，在奥斯陆的 SARS-CoV-2 检测站和挪威六个市的 COVID-19 暴发中，对 Panbio RAT 与 PCR 的检测结果进行比较，共采集了 4857 份平行样本。
本研究共纳入了 4857 例病例，其中 3991 例来自检测站，866 例来自暴发市。奥斯陆检测站的流行率为 6.3%，RAT 的总灵敏度为 74%。在有症状的患者（79%）和考虑病毒载量高于估计的感染水平的样本（84%）中观察到更高的灵敏度，而在无症状的患者中灵敏度较低（55%）。在暴发市，总体流行率为 6.9%，RAT 的总灵敏度为 70%。
我们的结果表明，该检测正确识别了大多数具有传染性的个体。然而，其灵敏度明显低于 PCR，在对检测个体进行随访时，牢记该检测的局限性非常重要。
