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Abstract Abstract Objective：To evaluate the performances of the novel coronavirus (SARS-CoV-2) specific antibody detection assays from six manufacturers. Methods: Serum samples from 245 patients (122 SARS-CoV-2 confirmed cases and 123 SARS-CoV-2 negative cases) admitted in Shanghai Public Health Clinical Centre from Jan 30th to May 11th 2020 were collected and tested by SARS-CoV-2 antibody detection assays purchased from six manufactures (3 uses colloidal gold strips while others are chemiluminescence immunoassays). Clinical sensitivity, clinical specificity, PPV, NPV and other parameters were analyzed to evaluate and compare the performances of different assays. Results: Assays had similar performances in terms of clinical specificity, but differ in clinical sensitivity. Compared to IgM detection, IgG detection seems more sensitive. CLIA assays had a sensitivity of 72.1~85.2% which was superior to that of colloidal gold (47.5~84.4%). All assays were determined to have statistically significant difference from PCR. The sensitivity of antibody detection increased over time, the sensitivity reached 96% after ≥16 days after PCR confirmation. Conclusion: SARS-CoV-2 antibody detection can serve as an auxiliary method to PCR in diagnosis. IgG and IgM joint detection may increase sensitivity in SARS-CoV-2 diagnosis. Performances of different assays varied a lot. Use of assays should depend on clinical requirement and application scenarios.
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Received: 30 July 2020
Published: 01 January 2022
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Corresponding Authors:
Zhao-qin ZHU
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| [1] |
Zheng J.SARS-CoV-2: an Emerging Coronavirus that Causes a Global Threat[J].International journal of biological ences, 2020, 16:1678-1685.
|
| [2] |
里进, 叶光明, 陈良君, 等. 新型冠状病毒（2019-nCoV）核酸检测假阴性结果原因分析及对策 [J/OL]. 中华检验医学杂志,2020,43 (2020-02-14).http://rs.yiigle.com/yufabiao/1181137.htm. DOI: 10.3760/cma.j.issn.1009-9158.2010.0006.[网络预发表].
|
| [3] |
莫茜, 秦炜, 傅启华, 等.正确认识新冠病毒核酸检测的影响因素 [J/OL][J].中华检验医学杂志, 2020, 43:-.
|
| [4] |
中华人民共和国国家卫生健康委员会.关于印发新型冠状病毒肺炎防控方案（第六版）的通知（国卫办疾控函〔2020〕204 号）[EB/OL]. (2020-03-07)[J].
|
| [5] |
Sun B, Feng Y, Mo X, et al.Kinetics of SARS-CoV-2 specific IgM and IgG responses in COVID-19 patients[J].Emerging Microbes and Infections, 2020, 2020:1-36.
|
| [6] |
中华人民共和国国家卫生健康委员会.关于印发新型冠状病毒肺炎诊疗方案（试行第七版）的通知（国卫办医函〔2020〕184 号）[EB/OL]. (2020-03-03).[J].
|
| [7] |
邱峰, 王慧君, 张子康, 等.新型冠状病毒--的实验室检测技术[J].南方医科大学学报, 2020, 2020:164-167.
|
| [8] |
徐万洲, 李娟, 何晓云, 等.血清新型冠状病毒和抗体联合检测在新型冠状病毒感染中的诊断价值[J].中华检验医学杂志, 2020, 43:E012-E012.
|
| [9] |
Li G, Lili R, Siyuan Y, et al.Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19)[J]. [J].Clinical Infectious Diseases, 2020.DOI：10.1093/cid/ciaa310.
|
| [10] |
Long, Q, Liu, B, Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. [J].Nat Med, 2020.DOI：10.1038/s41591-020-0897-1.
|
| [11] |
Wrapp D, Wang N, Corbett K S, et al.Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation[J].[J].Science, 2020, 367(6483):eabb2507.
|
| [12] |
Lee Y P, Lin R T P, Renia L, et al.Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and Control[J].Frontiers in Immunology, 2020, 11.DOI: 10.3389/fimmu.2020.00879.
|
| [13] |
Traugott M, Aberle SW, Aberle JH, et al.Performance of SARS-CoV-2 antibody assays in different stages of the infection: Comparison of commercial ELISA and rapid tests [published online ahead of print, 2020 May 30]. [J]., 2020, 222(3).DOI: 10.1093/infdis/jiaa305.
|
| [14] |
Yong G, Yi Y, Tuantuan L, et al.Evaluation of the auxiliary diagnostic value of antibody assays for the detection of novel coronavirus(SARS-CoV-2)[J].Journal of Medical Virology, 2020, https://doi.org/10.1002/jmv.25919.
|
| [15] |
Kontou P I, Braliou G G, Dimou N L, et al.Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis[J]., 2020, DOI: 10.1101/2020.04.22.20074914.
|
|
|
