Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus.

Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus.
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DOI:
10.1016/j.jcv.2020.104684
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发表时间:
2020-12
期刊:
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子:
--
通讯作者:
Tsang DN
Tsang DN
中科院分区:
其他
文献类型:
--
作者:
Mak GC;Lau SS;Wong KK;Chow NL;Lau CS;Lam ET;Chan RC;Tsang DN

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我们比较了三种商用的SARS-CoV-2病毒快速抗原检测(RAD)试剂盒。这三种RAD试剂盒的灵敏度比RT-PCR低102-105倍。RAD试剂盒检测新冠肺炎患者呼吸道标本的临床敏感性为22.9%~71.4%。了解不同RAD试剂盒的临床特征可以增加阳性结果的可能性。最近,市场上出现了许多用于诊断新冠肺炎患者的快速抗原检测试剂盒。比较三种市售RAD试剂盒的分析敏感性和临床敏感性。以RT-PCR为参照物,用检测限(LOD)确定检测SARS-CoV-2病毒的分析灵敏度。使用从确诊的新冠肺炎患者采集的呼吸道标本进行临床敏感性评估。LOD结果显示,三种RAD试剂盒的灵敏度比RT-PCR低102~105倍。RAD试剂盒检测新冠肺炎标本的临床敏感性为22.9%~71.4%。尽管RAD试剂盒不如RT-PCR敏感,但了解不同RAD试剂盒的临床特征可以指导我们获得合适的标本进行检测。RAD试剂盒出现阳性结果的可能性将更高。
We compared the three commercially available rapid antigen detection (RAD) kits for detection of SARS-CoV-2 virus. The three RAD kits varied from 102–105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %–71.4 % for detecting respiratory specimens from COVID-19 patients. Understanding the clinical characteristics of different RAD kits can increase the likelihood of positive results. 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 102–105 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.
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