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

被引：60
作者：
Mak, Gannon C. K. [1 ]
Lau, Stephen S. Y. [1 ]
Wong, Kitty K. Y. [1 ]
Chow, Nancy L. S. [1 ]
Lau, C. S. [1 ]
Lam, Edman T. K. [1 ]
Chan, Rickjason C. W. [1 ]
Tsang, Dominic N. C. [1 ]
机构：
[1] Ctr Hlth Protect, Dept Hlth, Publ Hlth Lab, All Microbiol Div,Serv Branch, Hong Kong, Peoples R China
来源：
JOURNAL OF CLINICAL VIROLOGY | 2021年 / 134卷
关键词：
2019 novel coronavirus; SARS-CoV-2; COVID-19; Rapid antigen detection; RT-PCR;
D O I：
10.1016/j.jcv.2020.104712
中图分类号：
Q93 [微生物学];
学科分类号：
071005 ; 100705 ;
摘要：
Background: Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2. Objective: The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2. Study Design: 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. Results: 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. Conclusions: 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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