Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium.
Leadlife B.V., Gent, Belgium.
Clin Microbiol Infect. 2020 Aug;26(8):1082-1087. doi: 10.1016/j.cmi.2020.05.023. Epub 2020 May 28.
To evaluate the diagnostic performance of seven rapid IgG/IgM tests and the Euroimmun IgA/IgG ELISA for antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in COVID-19 patients.
Specificity was evaluated in 103 samples collected before January 2020. Sensitivity and time to seropositivity was evaluated in 167 samples from 94 patients with COVID-19 confirmed with RT-PCR on nasopharyngeal swab.
Specificity (confidence interval) of lateral flow assays (LFAs) was ≥91.3% (84.0-95.5) for IgM, ≥90.3% (82.9-94.8) for IgG, and ≥85.4% (77.2-91.1) for the combination IgM OR IgG. Specificity of the ELISA was 96.1% (90.1-98.8) for IgG and only 73.8% (64.5-81.4) for IgA. Sensitivity 14-25 days after the onset of symptoms was between ≥92.1% (78.5-98.0) and 100% (95.7-100) for IgG LFA compared to 89.5% (75.3-96.4) for IgG ELISA. Positivity of IgM OR IgG for LFA resulted in a decrease in specificity compared to IgG alone without a gain in diagnostic performance, except for VivaDiag. The results for IgM varied significantly between the LFAs with an average overall agreement of only 70% compared to 89% for IgG. The average dynamic trend to seropositivity for IgM was not shorter than for IgG. At the time of hospital admission the sensitivity of LFA was <60%.
Sensitivity for the detection of IgG antibodies 14-25 days after the onset of symptoms was ≥92.1% for all seven LFAs compared to 89.5% for the IgG ELISA. The results for IgM varied significantly, and including IgM antibodies in addition to IgG for the interpretation of LFAs did not improve the diagnostic performance.
评估七种快速 IgG/IgM 检测试剂盒和 Euroimmun IgA/IgG ELISA 在 COVID-19 患者中针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）抗体的诊断性能。
特异性在 2020 年 1 月前采集的 103 份样本中进行评估。敏感性和血清阳性时间在 94 例经鼻咽拭子 RT-PCR 确诊的 COVID-19 患者的 167 份样本中进行评估。
侧向流动测定法（LFAs）的特异性（置信区间）为 IgM≥91.3%（84.0-95.5），IgG≥90.3%（82.9-94.8），IgM 和 IgG 联合检测≥85.4%（77.2-91.1）。ELISA 的特异性为 IgG 96.1%（90.1-98.8），而 IgA 仅为 73.8%（64.5-81.4）。与 IgG ELISA 相比，症状出现后 14-25 天 IgG LFA 的敏感性为≥92.1%（78.5-98.0）和 100%（95.7-100），而 IgG ELISA 为 89.5%（75.3-96.4）。与 IgG 相比，IgM 或 IgG 的 LFA 阳性导致特异性降低，而诊断性能没有提高，VivaDiag 除外。LFAs 之间 IgM 的结果差异显著，总体平均一致性仅为 70%，而 IgG 为 89%。IgM 出现血清阳性的平均动态趋势并不短于 IgG。住院时，LFA 的敏感性<60%。
在症状出现后 14-25 天，所有七种 LFAs 检测 IgG 抗体的敏感性均≥92.1%，而 IgG ELISA 为 89.5%。IgM 的结果差异显著，并且在解释 LFAs 时除 IgG 外还包括 IgM 抗体并没有提高诊断性能。
