Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Division of Infectious Diseases, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2020 Oct 22;15(10):e0240395. doi: 10.1371/journal.pone.0240395. eCollection 2020.
Coronavirus disease 2019 (COVID-19) is an emerging threat worldwide. This study aims to assess the serologic profiles and time kinetics of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with COVID-19 using two immunoassays.
A total of 97 samples serially collected from 17 patients with COVID-19 and 137 negative control samples were analyzed for IgM and IgG against SARS-CoV-2 using the AFIAS COVID-19 Ab (Boditech Med Inc., Chuncheon, Republic of Korea) and the EDI™ Novel Coronavirus COVID-19 ELISA Kit (Epitope Diagnostics, Inc., San Diego, CA).
With both assays, IgM and IgG rapidly increased after 7 days post symptom onset (PSO). IgM antibody levels reached a peak at 15-35 d PSO and gradually decreased. IgG levels gradually increased and remained at similar levels after 22-35 d. The diagnostic sensitivities of IgM/IgG for ≤14d PSO were 21.4%/35.757.1% and increased to 41.252.9%/88.2~94.1% at >14 d PSO with specificities of 98.5%/94.2% for AFIAS COVID-19 Ab and 100.0%/96.4% for EDI™ Novel Coronavirus COVID-19 ELISA Kit. Among 137 negative controls, 12 samples (8.8%) showed positive or indeterminate results.
The antibody kinetics against SARS-CoV-2 are similar to common findings of acute viral infectious diseases. Antibody testing is useful for ruling out SARS-CoV-2 infection after 14 d PSO, detecting past infection, and epidemiologic surveys.
2019 年冠状病毒病(COVID-19)是全球新出现的威胁。本研究旨在使用两种免疫分析法评估 COVID-19 患者针对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的血清学特征和时间动力学。
对 17 例 COVID-19 患者和 137 例阴性对照样本的 97 份连续采集样本进行分析,使用 AFIAS COVID-19 Ab(Boditech Med Inc.,韩国春川)和 EDI™新型冠状病毒 COVID-19 ELISA 试剂盒(Epitope Diagnostics,Inc.,加利福尼亚圣地亚哥)检测针对 SARS-CoV-2 的 IgM 和 IgG。
使用两种检测方法,IgM 和 IgG 在症状出现后 7 天(PSO)后迅速增加。IgM 抗体水平在 15-35 d PSO 时达到峰值,并逐渐下降。IgG 水平逐渐增加,在 22-35 d 后保持相似水平。对于≤14 d PSO,IgM/IgG 的诊断灵敏度分别为 21.4%/35.7-57.1%,在>14 d PSO 时增加至 41.2-52.9%/88.2-94.1%,特异性分别为 AFIAS COVID-19 Ab 的 98.5%/94.2%和 EDI™新型冠状病毒 COVID-19 ELISA 试剂盒的 100.0%/96.4%。在 137 例阴性对照中,有 12 例(8.8%)样本出现阳性或不确定结果。
针对 SARS-CoV-2 的抗体动力学与常见急性病毒感染性疾病的发现相似。抗体检测对于排除 14 d PSO 后 SARS-CoV-2 感染、检测既往感染和流行病学调查很有用。