Evaluation of rapid antigen detection kit from the WHO Emergency Use List for detecting SARS-CoV-2.

Evaluation of rapid antigen detection kit from the WHO Emergency Use List for detecting SARS-CoV-2.
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DOI:
10.1016/j.jcv.2020.104712
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发表时间:
2021-01
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 DNC
Tsang DNC
中科院分区:
其他
文献类型:
--
作者:
Mak GCK;Lau SSY;Wong KKY;Chow NLS;Lau CS;Lam ETK;Chan RCW;Tsang DNC

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目前,世界卫生组织紧急使用清单中有两种快速抗原检测(RAD)试剂盒用于检测SARS-CoV-2。选择Panbio COVID-19 Ag快速检测装置来评估检测SARS-CoV-2的性能。以RT-PCR为参考方法,通过检测限(LOD)确定检测SARS-CoV-2病毒的分析灵敏度。使用从确诊的COVID-19患者采集的呼吸道标本评估临床敏感性。检测结果表明,RAD试剂盒的灵敏度比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%。本研究中评估的RAD试剂盒与世卫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中决定不同的检测策略。
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.
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