All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region.
All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region.
J Clin Virol. 2021 Jan;134:104712. doi: 10.1016/j.jcv.2020.104712. Epub 2020 Dec 4.
Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2.
The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2.
Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.
The LOD results showed that the RAD kit was 100 fold less sensitive than RT-PCR. Clinical sensitivity of the RAD kit was 68.6 % for detecting specimens from COVID-19 patients.
The RAD kit evaluated in the present study shared similar performance with another kit from the WHO Emergency Use List, the Standard Q COVID-19 Ag. Understanding the clinical characteristics of RAD kits can guide us to decide different testing strategies in different settings.
目前，世界卫生组织紧急使用清单中有两种用于检测 SARS-CoV-2 的快速抗原检测（RAD）试剂盒。
选择 Panbio COVID-19 Ag 快速检测设备来评估其检测 SARS-CoV-2 的性能。
通过使用 RT-PCR 作为参考方法来确定检测 SARS-CoV-2 病毒的检测限（LOD），以确定分析灵敏度。使用从确诊 COVID-19 患者采集的呼吸道标本评估临床灵敏度。
LOD 结果表明，RAD 试剂盒比 RT-PCR 低 100 倍。RAD 试剂盒检测 COVID-19 患者标本的临床灵敏度为 68.6%。
本研究评估的 RAD 试剂盒与世界卫生组织紧急使用清单中的另一种试剂盒 Standard Q COVID-19 Ag 具有相似的性能。了解 RAD 试剂盒的临床特征可以指导我们在不同环境下制定不同的检测策略。
