Department of Respiratory and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
School of Urban Design, Wuhan University, Wuhan, China.
Clin Infect Dis. 2020 Nov 5;71(8):1930-1934. doi: 10.1093/cid/ciaa461.
The coronavirus disease 2019 (COVID-19), caused by infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been rapidly spreading nationwide and abroad. A serologic test to identify antibody dynamics and response to SARS-CoV-2 was developed.
The antibodies against SARS-CoV-2 were detected by an enzyme-linked immunosorbent assay based on the recombinant nucleocapsid protein of SARS-CoV-2 in patients with confirmed or suspected COVID-19 at 3-40 days after symptom onset. The gold standard for COVID-19 diagnosis was nucleic acid testing for SARS-CoV-2 by real-time reverse-transcription polymerase chain reaction (rRT-PCR). The serodiagnostic power of the specific immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 was investigated in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and consistency rate.
The seroconversion of specific IgM and IgG antibodies were observed as early as the fourth day after symptom onset. In the patients with confirmed COVID-19, sensitivity, specificity, PPV, NPV, and consistency rate of IgM were 77.3% (51/66), 100%, 100%, 80.0%, and 88.1%, respectively, and those of IgG were 83.3% (55/66), 95.0%, 94.8%, 83.8%, and 88.9%. In patients with suspected COVID-19, sensitivity, specificity, PPV, NPV, and consistency rate of IgM were 87.5% (21/24), 100%, 100%, 95.2%, and 96.4%, respectively, and those of IgG were 70.8% (17/24), 96.6%, 85.0%, 89.1%, and 88.1%. Both antibodies performed well in serodiagnosis for COVID-19 and rely on great specificity.
The antibodies against SARS-CoV-2 can be detected in the middle and later stages of the illness. Antibody detection may play an important role in the diagnosis of COVID-19 as a complementary approach to viral nucleic acid assays.
由严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)引起的 2019 年冠状病毒病(COVID-19)已在国内外迅速蔓延。现已开发出一种血清学检测方法,用于鉴定针对 SARS-CoV-2 的抗体动力学和反应。
采用基于 SARS-CoV-2 重组核衣壳蛋白的酶联免疫吸附试验,对确诊或疑似 COVID-19 患者在症状出现后 3-40 天内的 SARS-CoV-2 抗体进行检测。COVID-19 的诊断金标准为实时逆转录聚合酶链反应(rRT-PCR)检测 SARS-CoV-2 的核酸。根据敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)和一致性率,研究针对 SARS-CoV-2 的特异性免疫球蛋白 M(IgM)和免疫球蛋白 G(IgG)抗体的血清学诊断能力。
在症状出现后的第四天即可观察到特异性 IgM 和 IgG 抗体的血清转化。在确诊的 COVID-19 患者中,IgM 的敏感性、特异性、PPV、NPV 和一致性率分别为 77.3%(51/66)、100%、100%、80.0%和 88.1%,而 IgG 的敏感性、特异性、PPV、NPV 和一致性率分别为 83.3%(55/66)、95.0%、94.8%、83.8%和 88.9%。在疑似 COVID-19 患者中,IgM 的敏感性、特异性、PPV、NPV 和一致性率分别为 87.5%(21/24)、100%、100%、95.2%和 96.4%,而 IgG 的敏感性、特异性、PPV、NPV 和一致性率分别为 70.8%(17/24)、96.6%、85.0%、89.1%和 88.1%。两种抗体在 COVID-19 的血清学诊断中均表现良好,特异性高。
在疾病的中后期可检测到针对 SARS-CoV-2 的抗体。抗体检测可能在 COVID-19 诊断中发挥重要作用,作为病毒核酸检测的补充方法。