Clinical evaluation of a new COVID-19 antigen rapid test kit for detection of SARS-CoV-2

文献类型： 外文期刊

第一作者： Zhang, Wenjing

作者： Zhang, Wenjing;Zheng, Weiwei;Xu, Xiaoliang;Qi, Liangshuai;Liu, Mingkai;Zhao, Xiaoying;Kong, Lingshang;Wang, Yingji;Chen, Fengling;Zhang, Chao;Cheng, Jianghua

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关键词： COVID-19 antigen; Rapid test; Clinical evaluation; Detection; SARS

期刊名称：DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE （ 影响因子：2.9； 五年影响因子：2.5 ）

ISSN： 0732-8893

年卷期： 2024 年 108 卷 2 期

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收录情况： SCI

摘要： The antigen rapid diagnostic test (Ag-RDT) is an assay kit for detecting the SARS-COV-2 nucleocapsid proteins, based on the colloidal gold method.Accurate diagnosis has an important role in limiting the transmission of SARS-COV-2, and also helps patients to receive earlier treatment .The object of this study was to perform the clinical evaluation of a novel Ag-RDTs with samples collected from two different swabs.DEEPBLUE (R) COVID-19 antigen detection kit used for the examination of the subjects in the experiment.For antigen testing on samples collected with nasal swabs, sensitivity was 91.7 % (95 % CI 83.6-96.6 %) and specificity was 100 %(95 %CI 98.1100 %).For nasopharyngeal swabs, the sensitivity was 96.8 % (95 % CI 93.6-98.7 %) and the specificity was 100 % (95 % CI 98.2-100 %).Fisher Precision test showed a significant correlation between nasopharyngeal swab AgRDTs and nasal swab Ag-RDTs and RT-qPCR test (p-value <0.001).The results showed that the patients use the kit for testing were comparable to the RT-qPCR.

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