Laboratoire de Virologie, Service de Microbiologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; INSERM U970, PARCC, Hôpital Européen Georges Pompidou, Faculté de Médecine, Université de Paris, Paris, France; Faculté de Médecine, Université de Paris, Paris, France.
Laboratoire de Biochimie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.
J Clin Virol. 2020 Nov;132:104568. doi: 10.1016/j.jcv.2020.104568. Epub 2020 Aug 4.
Facing the ongoing pandemic caused by SARS-CoV-2, there is an urgent need for serological assays identifying individuals with on-going infection as well as past coronavirus infectious disease 2019 (COVID-19). We herein evaluated the analytical performances of the CE IVD-labeled Abbott SARS-CoV-2 IgG assay (Des Plaines, IL, USA) carried out with the automated Abbott Architect™ i2000 platform at Hôpital Européen Georges Pompidou, Paris, France, using serum sample panels obtained from health-workers with COVID-19 history confirmed by positive nucleic acid amplification-based diagnosis and from patients randomly selected for whom serum samples were collected before the COVID-19 epidemic. The Abbott SARS-CoV-2 IgG assay showed sensitivity of 94 % and specificity of 100 %, demonstrating high analytical performances allowing convenient management of suspected on-going and past-infections. In addition, the SARS-CoV-2 IgG positivity rates were compared in COVID-19 positive and COVID-19 free areas from our hospital. Thus, the frequency of SARS-CoV-2-specific IgG was around 10-fold higher in COVID-19 areas than COVID-19 free areas (75 % versus 8%; P < 0.001). Interestingly, several inpatients hospitalized in COVID-19 free areas suffering from a wide range of unexplained clinical features including cardiac, vascular, renal, metabolic and infectious disorders, were unexpectedly found seropositive for SARS-CoV-2 IgG by systematic routine serology, suggesting possible causal involvement of SARS-CoV-2 infection. Taken together, these observations highlight the potential interest of SARS-CoV-2-specific serology in the context of COVID-19 epidemic, especially to assess past SARS-CoV-2 infection as well as possible unexpected COVID-19-associated disorders.
面对由 SARS-CoV-2 引起的持续大流行，我们迫切需要血清学检测方法来识别现症感染以及过去的 2019 年冠状病毒病（COVID-19）感染。本研究在法国巴黎欧洲乔治·蓬皮杜医院，使用通过基于核酸扩增的阳性诊断确诊的 COVID-19 病史的医护人员血清样本以及在 COVID-19 流行之前采集的随机选择的患者血清样本，评估了雅培 SARS-CoV-2 IgG 检测试剂盒（雅培，美国伊利诺伊州德斯普兰斯）的分析性能。该检测试剂盒在自动化雅培 Architect™ i2000 平台上进行检测。雅培 SARS-CoV-2 IgG 检测试剂盒的敏感性为 94%，特异性为 100%，具有较高的分析性能，可方便管理现症和既往感染。此外，我们还比较了我院 COVID-19 阳性区和 COVID-19 阴性区的 SARS-CoV-2 IgG 阳性率。因此，COVID-19 阳性区 SARS-CoV-2 特异性 IgG 的频率比 COVID-19 阴性区高 10 倍（75%对 8%；P<0.001）。有趣的是，在 COVID-19 阴性区住院的一些患有多种不明原因的临床特征的患者，包括心脏、血管、肾脏、代谢和感染性疾病，他们的 SARS-CoV-2 特异性 IgG 意外地呈阳性，这提示 SARS-CoV-2 感染可能是这些疾病的病因。综上所述，这些结果提示 SARS-CoV-2 特异性血清学检测在 COVID-19 流行期间可能具有重要的应用价值，尤其是可以评估既往 SARS-CoV-2 感染以及可能存在的意外 COVID-19 相关疾病。
