文献类型： 外文期刊
作者： Zhang, Wenjing 1 ; Xu, Xiaoliang 2 ; Qi, Liangshuai 2 ; Liu, Mingkai 3 ; Zhao, Xiaoying 3 ; Kong, Lingshang 4 ; Wang, Yingji 5 ; Chen, Fengling 6 ; Zhang, Chao 6 ; Cheng, Jianghua 7 ; Zheng, Weiwei 1 ;
作者机构： 1.Univ Sci & Technol China, Affiliated Hosp USTC 1, Dept Lab Med, Div Life Sci & Med, Hefei 230001, Anhui, Peoples R China
2.Bengbu Med Coll, Sch Lab Med, Bengbu 233030, Anhui, Peoples R China
3.Shihezi Univ, Affiliated Hosp 1, Dept Lab Med, Shihezi 832008, Xinjiang, Peoples R China
4.Anhui Med Univ, Dept Gen Surg, Affiliated Hosp 2, Hefei 230601, Anhui, Peoples R China
5.Univ Elect Sci & Technol China, Sichuan Prov Peoples Hosp, Dept Geriatr Endocrinol, Chengdu 610072, Sichuan, Peoples R China
6.Anhui DeepBlue Med Technol Co Ltd, Hefei 230088, Anhui, Peoples R China
7.Anhui Acad Agr Sci, Inst Agr Prod Proc, Hefei 230031, Anhui, Peoples R China
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
页码：
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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