SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays
SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays
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DOI：
10.1016/j.cca.2020.06.004
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发表时间：
2020-10-01
影响因子：
5
通讯作者：
Zhao, Zhen
中科院分区：
文献类型：
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作者：
Yang, He S.;Racine-Brzostek, Sabrina E.;Zhao, Zhen
背景：在当前的 COVID-19 大流行中，迫切需要对血清学测定进行综合性能评估和临床实用性评估，以了解对 SARS-CoV-2 的免疫反应。方法：分别通过循环增强荧光测定（CEFA）和微球免疫测定（MIA）测量针对 SARS-CoV-2 的 IgM/IgG 和总抗体。独立性能评估包括不精确性、再现性、特异性和交叉反应性（CEFA n = 320，MIA n = 364）。通过这两种方法对 87 名初次急诊就诊的患者、28 名随后住院期间的患者（106 个连续样本）和 145 名康复患者进行了临床实用性评估。总共评估了916名患者和994个样本。结果：302个样本中CEFA和MIA的一致性为90.4％-94.5％（Kappa：0.81-0.89）。 CEFA 和 MIA 分别在 26.2% 和 26.3% 的 ED 患者中检测到 SARS-CoV-2 抗体。检测率随着时间的推移而增加，在症状出现后 21 天后达到 100%。 CEFA 和 MIA 测量的纵向抗体动力学变化相关性良好，并表现出三种类型的血清转化。恢复期血清显示出广泛的抗体水平。 结论：经过严格验证的 CEFA 和 MIA 检测对于检测 SARS-CoV-2 抗体是可靠的，并且在评估住院和恢复期患者的免疫反应时显示出有前景的临床实用性，但对于患者初次急诊就诊时的早期筛查没有用处。
Background: In the ongoing COVID-19 pandemic, there is an urgent need for comprehensive performance evaluation and clinical utility assessment of serological assays to understand the immune response to SARS-CoV-2.Methods: IgM/IgG and total antibodies against SARS-CoV-2 were measured by a cyclic enhanced fluorescence assay (CEFA) and a microsphere immunoassay (MIA), respectively. Independent performance evaluation included imprecision, reproducibility, specificity and cross-reactivity (CEFA n = 320, MIA n = 364). Clinical utility was evaluated by both methods in 87 patients at initial emergency department visit, 28 during subsequent hospitalizations (106 serial samples), and 145 convalescent patients. Totally 916 patients and 994 samples were evaluated.Results: Agreement of CEFA and MIA was 90.4%-94.5% (Kappa: 0.81-0.89) in 302 samples. CEFA and MIA detected SARS-CoV-2 antibodies in 26.2% and 26.3%, respectively, of ED patients. Detection rates increased over time reaching 100% after 21 days post-symptom onset. Longitudinal antibody kinetic changes by CEFA and MIA measurements correlated well and exhibited three types of seroconversion. Convalescent sera showed a wide range of antibody levels.Conclusion: Rigorously validated CEFA and MIA assays are reliable for detecting antibodies to SARS-CoV-2 and show promising clinical utility when evaluating immune response in hospitalized and convalescent patients, but are not useful for early screening at patient's initial ED visit.