机构：[1]The Key Laboratory for Biomedical Photonics of MOE at Wuhan National Laboratory for Optoelectronics - Hubei Bioinformatics & Molecular Imaging Key Laboratory, Systems Biology Theme, Department of Biomedical Engineering, College of Life Science and Technology, Huazhong University of Science and Technology, Wuhan, Hubei, P.R. China.[2]Reagent R&D Center, Shenzhen YHLO Biotech Co., Ltd, YHLO Bioscience Building, Shenzhen, Guangdong, P.R. China.[3]Department of Medical Laboratory and Pathology Center, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, P.R. China.[4]Department of Laboratory Medicine, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, P.R. China.[5]Department of Clinical Laboratory, Renmin Hospital of Wuhan University, Wuhan, Hubei, P.R. China.[6]Department of Clinical Laboratory, Wuhan Asia General Hospital, Wuhan, Hubei, P.R. China.[7]Department of Clinical Laboratory, Huangshi Central Hospital, Edong Healthcare Group (Affiliated Hospital of Hubei Polytechnic University), Huangshi, Hubei, P.R. China.[8]Department of Clinical Laboratory, TongJi Hospital, TongJi Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, P.R. China.华中科技大学同济医学院附属同济医院[9]Department of Clinical Laboratory, Changshou People's Hospital, Chongqing, P.R. China.[10]Department of Clinical Laboratory, Shenzhen Maternity & Child Healthcare Hospital, Shenzhen, Guangdong, P.R. China.深圳市妇幼保健院深圳市康宁医院深圳医学信息中心[11]Department of Clinical Laboratory, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, P.R. China.[12]Department of Clinical Laboratory, Affiliated Hospital of Shaoxing University, Shaoxing, Zhejiang, P.R. China.
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.
第一作者机构：[1]The Key Laboratory for Biomedical Photonics of MOE at Wuhan National Laboratory for Optoelectronics - Hubei Bioinformatics & Molecular Imaging Key Laboratory, Systems Biology Theme, Department of Biomedical Engineering, College of Life Science and Technology, Huazhong University of Science and Technology, Wuhan, Hubei, P.R. China.
推荐引用方式(GB/T 7714)：
Qian Chungen,Zhou Mi,Cheng Fangming,et al.Development and multicenter performance evaluation of fully automated SARS-CoV-2 IgM and IgG immunoassays.[J].CLINICAL CHEMISTRY AND LABORATORY MEDICINE.2020,58(9):1601-1607.doi:10.1515/cclm-2020-0548.
APA：
Qian Chungen,Zhou Mi,Cheng Fangming,Lin Xiaotao,Gong Yijun...&Xia Fuzhen.(2020).Development and multicenter performance evaluation of fully automated SARS-CoV-2 IgM and IgG immunoassays..CLINICAL CHEMISTRY AND LABORATORY MEDICINE,58,(9)
MLA：
Qian Chungen,et al."Development and multicenter performance evaluation of fully automated SARS-CoV-2 IgM and IgG immunoassays.".CLINICAL CHEMISTRY AND LABORATORY MEDICINE 58..9(2020):1601-1607
