Central Virology Laboratory and Sheba Medical Center, Ministry of Health, Tel-Hashomer, Israel.
School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
PLoS One. 2020 Nov 23;15(11):e0241164. doi: 10.1371/journal.pone.0241164. eCollection 2020.
The COVID-19 pandemic and the fast global spread of the disease resulted in unprecedented decline in world trade and travel. A critical priority is, therefore, to quickly develop serological diagnostic capacity and identify individuals with past exposure to SARS-CoV-2. In this study serum samples obtained from 309 persons infected by SARS-CoV-2 and 324 of healthy, uninfected individuals as well as serum from 7 COVID-19 patients with 4-7 samples each ranging between 1-92 days post first positive PCR were tested by an "in house" ELISA which detects IgM, IgA and IgG antibodies against the receptor binding domain (RBD) of SARS-CoV-2. Sensitivity of 47%, 80% and 88% and specificity of 100%, 98% and 98% in detection of IgM, IgA and IgG antibodies, respectively, were observed. IgG antibody levels against the RBD were demonstrated to be up regulated between 1-7 days after COVID-19 detection, earlier than both IgM and IgA antibodies. Study of the antibody kinetics of seven COVID 19 patients revealed that while IgG levels are high and maintained for at least 3 months, IgM and IgA levels decline after a 35-50 days following infection. Altogether, these results highlight the usefulness of the RBD based ELISA, which is both easy and cheap to prepare, to identify COVID-19 patients even at the acute phase. Most importantly our results demonstrate that measuring IgG levels alone is both sufficient and necessary to diagnose past exposure to SARS-CoV-2.
COVID-19 大流行和疾病在全球的快速传播导致世界贸易和旅行出现前所未有的下降。因此,当务之急是快速开发血清学诊断能力,并确定过去接触过 SARS-CoV-2 的个体。在这项研究中,我们使用一种“内部”ELISA 检测试剂盒,对 309 名感染 SARS-CoV-2 的患者、324 名健康未感染的个体以及 7 名 COVID-19 患者(每个患者有 4-7 个血清样本,间隔时间为 1-92 天)的血清样本进行了检测,该 ELISA 检测试剂盒可检测针对 SARS-CoV-2 受体结合域(RBD)的 IgM、IgA 和 IgG 抗体。我们观察到,检测 IgM、IgA 和 IgG 抗体的敏感性分别为 47%、80%和 88%,特异性分别为 100%、98%和 98%。在 COVID-19 检测后 1-7 天内,RBD 上的 IgG 抗体水平被证明上调,早于 IgM 和 IgA 抗体。对 7 名 COVID-19 患者的抗体动力学研究表明,尽管 IgG 水平较高且至少维持 3 个月,但在感染后 35-50 天,IgM 和 IgA 水平下降。总之,这些结果突出了基于 RBD 的 ELISA 的有用性,该 ELISA 既易于制备又廉价,即使在急性阶段也可用于识别 COVID-19 患者。最重要的是,我们的结果表明,单独测量 IgG 水平即可充分且必要地诊断过去是否接触过 SARS-CoV-2。