All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.
All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.
J Clin Virol. 2020 Dec;133:104684. doi: 10.1016/j.jcv.2020.104684. Epub 2020 Oct 29.
Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.
To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.
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 three RAD kits varied from 10-10 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.
Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.
目前市场上有许多用于诊断 COVID-19 患者的快速抗原检测 (RAD) 试剂盒。
比较三种市售 RAD 试剂盒的分析灵敏度和临床灵敏度。
采用 RT-PCR 作为参考方法，通过检测限 (LOD) 来确定 SARS-CoV-2 病毒的分析灵敏度。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，三种 RAD 试剂盒的灵敏度比 RT-PCR 低 10-10 倍。RAD 试剂盒检测 COVID-19 患者标本的临床灵敏度为 22.9%-71.4%。
尽管 RAD 试剂盒的灵敏度低于 RT-PCR，但了解不同 RAD 试剂盒的临床特征可以指导我们获得适合检测的标本。RAD 试剂盒的阳性结果的可能性将会更高。
