Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG.
Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG.
复制标题
DOI：
10.1016/j.jcv.2020.104394
复制
发表时间：
2020-07-01
期刊：
影响因子：
--
通讯作者：
Kleines, Michael
中科院分区：
文献类型：
--
作者：
Kruttgen, Alexander;Cornelissen, Christian G;Kleines, Michael
背景：面对由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的持续的大流行，迫切需要血清学检测来识别患有2019年冠状病毒疾病的个体(新冠肺炎)。研究设计：我们的研究首次比较了四种新的商用检测方法，使用75份SARS-CoV-2聚合酶链式反应(SARS-CoV-2)阳性或阴性患者的血清：抗SARS-CoV-2 ELISA(Ig G)(欧洲免疫联盟，德国)、EDI新冠状病毒新冠肺炎Ig G EL ISA(美国)、Recomwell SARS-CoV-2 Ig G L ISA(M ikgen，德国)结果：欧洲免疫试验、EDI试验、混合原试验和病毒试验的敏感性分别为86.4%、100%、86.4%和77.3%，特异性分别为96、2%、88，7%、100%和100%。结论：商品化的SARS-CoV-2抗体检测方法具有足够的特异性和敏感性。
BACKGROUND: Facing the ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is an urgent need for serological assays identifying individuals with past coronavirus disease 2019 (COVID-19).STUDY DESIGN: Our study is the first to compare four new commercially available assays using 75 sera from patients tested positive or negative by SARS-CoV-2 PCR: the anti SARS-CoV-2 ELISA (IgG) (Euroimmun, Germany), the EDI New Coronavirus COVID-19 IgG ELISA, (Epitope diagnostics (EDI), USA), the recomWell SARS-CoV-2 IgG ELISA (Mikrogen, Germany), and the SARS-CoV-2 Virachip IgG (Viramed, Germany).RESULTS: We found a sensitivity of 86.4 %, 100 %, 86.4 %, and 77.3 % and a specificity of 96,2 %, 88,7 %, 100 %, and 100 % for the Euroimmun assay, the EDI assay, the Mikrogen assay, and the Viramed assay, respectively.CONCLUSIONS: Commercially available SARS-CoV-2 IgG assays have a sufficient specificity and sensitivity for identifying individuals with past SARS-CoV-2 infection.