Performance evaluation of three automated quantitative immunoassays and their correlation with a surrogate virus neutralization test in coronavirus disease 19 patients and pre-pandemic controls.

Performance evaluation of three automated quantitative immunoassays and their correlation with a surrogate virus neutralization test in coronavirus disease 19 patients and pre-pandemic controls.
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DOI:
10.1002/jcla.23921
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发表时间:
2021-09
影响因子:
2.7
通讯作者:
Song EY
Song EY
中科院分区:
医学4区
文献类型:
--
作者:
Jung K;Shin S;Nam M;Hong YJ;Roh EY;Park KU;Song EY

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SARS-CoV-2大流行目前正在进行,同时一些国家正在迅速进行疫苗接种。根据SARS-CoV-2刺突抗原抗体与中和抗体相关性较好的结果,建立了检测SARS-CoV-2刺突抗原抗体的定量免疫分析方法。雅培建筑师SARS-CoV-2Ig G II Quant、DiaSorin联络员SARS-CoV-2 TrimericS Ig G和罗氏抗SARS-CoV-2抗体S分别对12 6例SARS-CoV-2患者和15 1例流行前血清进行了检测。同时对126例SARS-CoV-2患者173份血清进行检测,分析其与GenScript cPass SARS-CoV-2和中和抗体检测试剂盒的相关性。建筑师SARS-CoV-2Ig G II Quant和Electrsys抗SARS-CoV-2 S的总体敏感度最高(96.0%),其次是联络员SARS-CoV-2和TrimericS Ig G(93.6%)。抗SARS-CoV-2 S和SARS-CoV-2与三聚体抗体的特异性为100.0%,其次是建筑师抗SARS-CoV-2Ig G II Quant(99.3%)。在与cPASS中和抗体检测的相关性方面,联络SARS-CoV-2与TrimericS的相关性最好(Spearman Rho=40.88),其次是建筑师SARS-CoV-2Ig GⅡQuant和Electrsys抗SARS-CoV-2的S(均为Rho=40.87)。这三种自动化定量免疫分析方法显示出良好的诊断性能,并与中和抗体有很强的相关性。这些检测方法将在今后的诊断辅助、评估疫苗接种反应和评估群体免疫方面发挥作用。3种检测SARS-CoV-2刺突蛋白抗体的自动定量免疫分析方法Abbott SARS-CoV-2Ig G II Quant、DiaSorin联络人SARS-CoV-2 TrimericS Ig G和Roche Electrsys抗SARS-CoV-2 S的检测结果具有可比性,具有较高的敏感性和特异性。这三种免疫检测方法与GenScrip cPass病毒中和试验有很强的相关性。
SARS‐CoV‐2 pandemic is currently ongoing, meanwhile vaccinations are rapidly underway in some countries. The quantitative immunoassays detecting antibodies against spike antigen of SARS‐CoV‐2 have been developed based on the findings that they have a better correlation with the neutralizing antibody. The performances of the Abbott Architect SARS‐CoV‐2 IgG II Quant, DiaSorin LIAISON SARS‐CoV‐2 TrimericS IgG, and Roche Elecsys anti‐SARS‐CoV‐2 S were evaluated on 173 sera from 126 SARS‐CoV‐2 patients and 151 pre‐pandemic sera. Their correlations with GenScript cPass SARS‐CoV‐2 Neutralization Antibody Detection Kit were also analyzed on 173 sera from 126 SARS‐CoV‐2 patients. Architect SARS‐CoV‐2 IgG II Quant and Elecsys anti‐SARS‐CoV‐2 S showed the highest overall sensitivity (96.0%), followed by LIAISON SARS‐CoV‐2 TrimericS IgG (93.6%). The specificities of Elecsys anti‐SARS‐CoV‐2 S and LIAISON SARS‐CoV‐2 TrimericS IgG were 100.0%, followed by Architect SARS‐CoV‐2 IgG II Quant (99.3%). Regarding the correlation with cPass neutralization antibody assay, LIAISON SARS‐CoV‐2 TrimericS IgG showed the best correlation (Spearman rho = 0.88), followed by Architect SARS‐CoV‐2 IgG II Quant and Elecsys anti‐SARS‐CoV‐2 S (all rho = 0.87). The three automated quantitative immunoassays showed good diagnostic performance and strong correlations with neutralization antibodies. These assays will be useful in diagnostic assistance, evaluating the response to vaccination, and the assessment of herd immunity in the future. The performances of three automated quantitative immunoassays detecting antibodies against SARS‐CoV‐2 spike protein, Abbott SARS‐CoV‐2 IgG II Quant; DiaSorin LIAISON SARS‐CoV‐2 TrimericS IgG; Roche Elecsys anti‐SARS‐CoV‐2 S were comparable, with superior sensitivity and specificity. The three immunoassays demonstrated strong correlations with GenScript cPass virus neutralization test.
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