المؤلفون: Zhang P; State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Beijing, 100071, People's Republic of China.; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China., Gao Q; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China., Wang T; Wuhan University School of Health Sciences, Wuhan, 430071, People's Republic of China., Ke Y; Huoshenshan Hospital, Wuhan, 430101, People's Republic of China., Mo F; Center for Clinical Laboratories, Affiliated Hospital of Guizhou Medical University, Guiyang, 550004, People's Republic of China.; Department of Basic Clinical Laboratory Medicine, School of Clinical Laboratory Science, Guizhou Medical University, Guiyang, 550004, People's Republic of China., Jia R; Huoshenshan Hospital, Wuhan, 430101, People's Republic of China., Liu W; General Hospital of Central Theater Command of the PLA, Wuhan, 430070, People's Republic of China., Liu L; General Hospital of Central Theater Command of the PLA, Wuhan, 430070, People's Republic of China., Zheng S; General Hospital of Central Theater Command of the PLA, Wuhan, 430070, People's Republic of China., Liu Y; Shijiazhuang Fifth Hospital, Shijiazhuang, 050023, People's Republic of China., Li L; The Sixth People's Hospital of Shenyang, Shenyang, 110006, People's Republic of China., Wang Y; Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100032, People's Republic of China., Xu L; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China., Hao K; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China., Min W; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China., Liu X; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China., Yang R; State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Beijing, 100071, People's Republic of China.; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China., Li S; Wuhan University School of Health Sciences, Wuhan, 430071, People's Republic of China. lsywhd@sina.com., Lin C; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China. changqing.lin@hotgen.com.cn.; Beijing Hotgen Biotechnology Inc., Beijing, 102600, People's Republic of China. changqing.lin@hotgen.com.cn., Zhao Y; State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Beijing, 100071, People's Republic of China. zhaoyong179@139.com.; Beijing Key Laboratory of POCT for Bioemergency and Clinic, Beijing, 100071, People's Republic of China. zhaoyong179@139.com.

المصدر: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology [Eur J Clin Microbiol Infect Dis] 2021 May; Vol. 40 (5), pp. 921-928. Date of Electronic Publication: 2020 Nov 12.

نوع المنشور: Evaluation Study; Journal Article

بيانات الدورية: Publisher: Springer Country of Publication: Germany NLM ID: 8804297 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1435-4373 (Electronic) Linking ISSN: 09349723 NLM ISO Abbreviation: Eur J Clin Microbiol Infect Dis Subsets: MEDLINE

مواضيع طبية MeSH: COVID-19/*diagnosis , COVID-19 Serological Testing/*methods , SARS-CoV-2/*isolation & purification , Spike Glycoprotein, Coronavirus/*immunology, Antibodies, Viral/blood ; COVID-19/blood ; COVID-19 Nucleic Acid Testing ; Coronavirus Nucleocapsid Proteins/genetics ; Coronavirus Nucleocapsid Proteins/immunology ; Humans ; Immunoassay ; Phosphoproteins/genetics ; Phosphoproteins/immunology ; RNA, Viral/genetics ; Recombinant Proteins/genetics ; Recombinant Proteins/immunology ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Sensitivity and Specificity ; Spike Glycoprotein, Coronavirus/genetics

مستخلص: Serological test is a valuable diagnostic tool for coronavirus disease 2019 (COVID-19). However, considerable improvements to these tests are needed, especially in the detection sensitivity. In this study, six recombinant nucleocapsid and spike proteins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were prepared and evaluated, including three prokaryotic expression nucleocapsid proteins (rN, rN1, rN2) and three eukaryotic expression spike proteins (rS1, rS-RBD, rS-RBD-mFc). The recombinant proteins with the highest ELISA titers (rS1 and rS-RBD-mFc) were selected to develop a double-antigen sandwich colloidal gold immunochromatography assay (GICA) to detect total antibodies against SARS-CoV-2. The clinical evaluation results showed that the sensitivity and specificity of GICA were 92.09% (419/455) and 99.44% (706/710), respectively. Moreover, a significant number (65.63%, 21/32) of COVID-19 patients with undetectable viral RNA were correctly diagnosed by the GICA method. In conclusion, the eukaryotic expression spike proteins (rS1 and rS-RBD-mFc) are more suitable than the prokaryotic expression nucleocapsid proteins for serological diagnosis of SARS-CoV-2. The proposed GICA for detection of total antibodies could be a powerful complement to the current RNA tests for COVID-19.

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