文献类型：期刊文献

英文题名：Development and multicenter performance evaluation of fully automated SARS-CoV-2 IgM and IgG immunoassays

作者：Qian, Chungen[2];Zhou, Mi[1];Cheng, Fangming[1];Lin, Xiaotao[1];Gong, Yijun[1];Xie, Xiaobing[3,4];Li, Ping[3,4];Li, Zhiyong[5];Zhang, Pingan[6];Liu, Zejin[7];Hu, Fang[8];Wang, Yun[9];Li, Quan[10];Zhu, Yan[11];Duan, Guikai[11];Xing, Yinting[12];Song, Huanyu[12];Xu, Wenfang[13];Liu, Bi-Feng[2];Xia, Fuzhen[1]

机构：[1]Shenzhen YHLO Biotech Co Ltd, Reagent R&D Ctr, YHLO Biosci Bldg,Baolong 2nd Rd, Shenzhen, Guangdong, Peoples R China;[2]Huazhong Univ Sci & Technol, Coll Life Sci & Technol, Dept Biomed Engn,Hubei Bioinformat & Mol Imaging, Syst Biol Theme,Key Lab Biomed Photon MOE,Wuhan N, Wuhan, Hubei, Peoples R China;[3]Hunan Univ Chinese Med, Affiliated Hosp 1, Dept Med Lab, Changsha, Hunan, Peoples R China;[4]Hunan Univ Chinese Med, Affiliated Hosp 1, Pathol Ctr, Changsha, Hunan, Peoples R China;[5]Xiamen Univ, Affiliated Hosp 1, Dept Lab Med, Xiamen, Fujian, Peoples R China;[6]Wuhan Univ, Renmin Hosp, Dept Clin Lab, Wuhan, Hubei, Peoples R China;[7]Wuhan Asia Gen Hosp, Dept Clin Lab, Wuhan, Hubei, Peoples R China;[8]Hubei Polytech Univ, Affiliated Hosp, Huangshi Cent Hosp, Dept Clin Lab,Edong Healthcare Grp, Huangshi, Hubei, Peoples R China;[9]Huazhong Univ Sci & Technol, TongJi Hosp, TongJi Med Coll, Dept Clin Lab, Wuhan, Hubei, Peoples R China;[10]Changshou Peoples Hosp, Dept Clin Lab, Chongqing, Peoples R China;[11]Shenzhen Matern & Child Healthcare Hosp, Dept Clin Lab, Shenzhen, Guangdong, Peoples R China;[12]Harbin Med Univ, Affiliated Hosp 1, Dept Clin Lab, Harbin, Heilongjiang, Peoples R China;[13]Shaoxing Univ, Affiliated Hosp, Dept Clin Lab, Shaoxing, Zhejiang, Peoples R China

年份：2020

卷号：58

期号：9

起止页码：1601

外文期刊名：CLINICAL CHEMISTRY AND LABORATORY MEDICINE

收录：SCI-EXPANDED(收录号：WOS:000560715100036)、、Scopus(收录号：2-s2.0-85088653829)、WOS

基金：B.F. Liu, Fundamental Research Funds for the Central Universities (2020kfyXGYJ103).

语种：英文

外文关键词：chemiluminescent; COVID-19; evaluation; immunoassay; SARS-CoV-2 IgG and SARS-CoV-2 IgM antibodies; SARS-CoV-2

外文摘要：Objectives: The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread globally. The laboratory diagnosis of SARS-CoV-2 infection has relied on nucleic acid testing; however, it has some limitations, such as low throughput and high rates of false negatives. Tests of higher sensitivity are needed to effectively identify infected patients. Methods: This study has developed fully automated chemiluminescent immunoassays to determine IgM and IgG antibodies to SARS-CoV-2 in human serum. The assay performance has been evaluated at 10 hospitals. Clinical specificity was evaluated by measuring 972 hospitalized patients and 586 donors of a normal population. Clinical sensitivity was assessed on 513 confirmed cases of SARS-CoV-2 by RT-PCR. Results: The assays demonstrated satisfied assay precision with coefficient of variation of less than 4.45%. Inactivation of specimen did not affect assay measurement. SARS-CoV-2 IgM showed clinical specificity of 97.33 and 99.49% for hospitalized patients and the normal population respectively, and SARS-CoV-2 IgG showed clinical specificity of 97.43 and 99.15% respectively. SARS-CoV-2 IgM showed clinical sensitivity of 82.54, 92.93, and 84.62% before 7 days, 7-14 days, and after 14 days respectively, since onset of symptoms, and SARS-CoV-2 IgG showed clinical sensitivity of 80.95, 97.98, and 99.15% respectively at the same time points above. Conclusions: We have developed fully automated immunoassays for detecting SARS-CoV-2 IgM and IgG antibodies in human serum. The assays demonstrated high clinical specificity and sensitivity, and add great value to nucleic acid testing in fighting against the global pandemic of the SARS-CoV-2 infection.