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.
Reagent R&D Center, Shenzhen YHLO Biotech Co., Ltd, YHLO Bioscience Building, Shenzhen, Guangdong, P.R. China.
Clin Chem Lab Med. 2020 Jul 15;58(9):1601-1607. doi: 10.1515/cclm-2020-0548. Print 2020 Aug 27.
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.
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.
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.
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.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的爆发已在全球范围内迅速蔓延。SARS-CoV-2 感染的实验室诊断依赖于核酸检测；然而，它存在一些局限性，例如通量低和假阴性率高。需要更高灵敏度的测试来有效识别感染患者。
本研究开发了全自动化学发光免疫分析方法，用于测定人血清中的 SARS-CoV-2 IgM 和 IgG 抗体。在 10 家医院评估了该方法的性能。通过测量 972 名住院患者和 586 名正常人群供体，评估了临床特异性。通过 RT-PCR 对 513 例确诊的 SARS-CoV-2 病例进行了临床敏感性评估。
该测定具有令人满意的测定精密度，变异系数小于 4.45%。标本灭活不影响测定测量。SARS-CoV-2 IgM 对住院患者和正常人群的临床特异性分别为 97.33%和 99.49%，SARS-CoV-2 IgG 分别为 97.43%和 99.15%。SARS-CoV-2 IgM 在症状出现后 7 天、7-14 天和 14 天后的临床敏感性分别为 82.54%、92.93%和 84.62%，SARS-CoV-2 IgG 的临床敏感性分别为 80.95%、97.98%和 99.15%。
我们已经开发了用于检测人血清中 SARS-CoV-2 IgM 和 IgG 抗体的全自动免疫分析方法。该测定具有高临床特异性和敏感性，为核酸检测在对抗 SARS-CoV-2 感染的全球大流行提供了重要价值。
