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

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

doi:10.1016/j.diagmicrobio.2023.116136

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

Diagn Microbiol Infect Dis. 2024 Feb;108(2):116136. doi: 10.1016/j.diagmicrobio.2023.116136. Epub 2023 Nov 21.

Authors

Wenjing Zhang¹, Xiaoliang Xu², Liangshuai Qi², Mingkai Liu³, Xiaoying Zhao³, Lingshang Kong⁴, Yingji Wang⁵, Fengling Chen⁶, Chao Zhang⁷, Jianghua Cheng⁸, Weiwei Zheng⁹

Affiliations

¹ Department of Laboratory Medicine, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.
² School of Laboratory Medicine, Bengbu Medical College, Bengbu 233030, Anhui, China.
³ Department of Laboratory Medicine, The First Affiliated Hospital, Shihezi University, Shihezi 832008, Xinjiang, China.
⁴ Department of General Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, Anhui, China.
⁵ Department of Geriatric Endocrinology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, 610072, Sichuan, China.
⁶ Anhui DeepBlue Medical Technology Co. Ltd., Hefei, 230088, Anhui, China.
⁷ Anhui DeepBlue Medical Technology Co. Ltd., Hefei, 230088, Anhui, China. Electronic address: 408113034@qq.com.
⁸ Institute of Agricultural Products Processing, Anhui Academy of Agricultural Sciences, Hefei 230031, Anhui, China. Electronic address: elmcheng@aaaa.org.cn.
⁹ Department of Laboratory Medicine, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: zhengweiwei2009@163.com.

PMID: 38041889
DOI: 10.1016/j.diagmicrobio.2023.116136

Abstract

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®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 98.1-100 %).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 Ag-RDTs 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.

Keywords: COVID-19 antigen; Clinical evaluation; Detection; Rapid test; SARS.

MeSH terms

Biological Assay
COVID-19* / diagnosis
Humans
SARS-CoV-2*
Sensitivity and Specificity