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四种自动化免疫分析和三种 ELISA 评估针对 SARS-CoV-2 刺突蛋白和核蛋白的抗体反应。

Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs.

机构信息

Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium.

Laboratory of Microbiology, Jan Yperman Hospital, Ieper, Belgium.

出版信息

Clin Microbiol Infect. 2020 Nov;26(11):1557.e1-1557.e7. doi: 10.1016/j.cmi.2020.07.038. Epub 2020 Jul 31.

Abstract

OBJECTIVES

The aim was to determine the antibody response against SARS-CoV-2 spike protein and nucleoprotein using four automated immunoassays and three ELISAs for the detection of total Ig antibodies (Roche) or IgG (Abbott, Diasorin, Snibe, Euroimmun, Mikrogen) in COVID-19 patients.

METHODS

Sensitivity and dynamic trend to seropositivity were evaluated in 233 samples from 114 patients with moderate, severe or critical COVID-19 confirmed with PCR on nasopharyngeal swab. Specificity was evaluated in 113 samples collected before January 2020, including 24 samples from patients with non-SARS coronavirus infection.

RESULTS

Sensitivity for all assays was 100% (95% confidence interval 83.7-100) 3 weeks after onset of symptoms. Specificity varied between 94.7% (88.7-97.8) and 100% (96.1-100). Calculated at the cut-offs that corresponded to a specificity of 95% and 97.5%, Roche had the highest sensitivity (85.0% (79.8-89.0) and 81.1% (76.6-85.7), p < 0.05 except vs. Abbott). Seroconversion occurred on average 2 days earlier for Roche total Ig anti-N and the three IgG anti-N assays (Abbott, Mikrogen, Euroimmun) than for the two IgG anti-S assays (Diasorin, Euroimmun) (≥50% seroconversion day 9-10 vs. day 11-12 and p < 0.05 for percent seropositive patients day 9-10 to 17-18). There was no significant difference in the IgG antibody time to seroconversion between critical and non-critical patients.

DISCUSSION

Seroconversion occurred within 3 weeks after onset of symptoms with all assays and on average 2 days earlier for assays detecting IgG or total Ig anti-N than for IgG anti-S. The specificity of assays detecting anti-N was comparable to anti-S and excellent in a challenging control population.

摘要

目的

使用四种自动化免疫分析和三种 ELISA 检测试剂盒(罗氏、雅培、迪亚森、Snibe、欧蒙、美康)检测总 Ig 抗体(罗氏)或 IgG(雅培、迪亚森、Snibe、欧蒙、美康),以确定针对 SARS-CoV-2 刺突蛋白和核蛋白的抗体反应。

方法

评估了 233 份来自 114 例经鼻咽拭子 PCR 确诊的中度、重度或危重新冠肺炎患者的样本的敏感性和血清阳性的动态趋势。在 2020 年 1 月之前采集的 113 份样本中评估了特异性,其中包括 24 份非 SARS 冠状病毒感染患者的样本。

结果

所有检测方法的敏感性均为 100%(95%置信区间 83.7-100),症状出现后 3 周。特异性在 94.7%(88.7-97.8)和 100%(96.1-100)之间变化。在特异性为 95%和 97.5%对应的截定点计算时,罗氏的敏感性最高(85.0%(79.8-89.0)和 81.1%(76.6-85.7),除与雅培相比外,p<0.05)。罗氏总 Ig 抗-N 和三种 IgG 抗-N 检测试剂盒(雅培、美康、欧蒙)的血清转换平均比两种 IgG 抗-S 检测试剂盒(迪亚森、欧蒙)早 2 天(≥50%血清转换第 9-10 天 vs. 第 11-12 天,p<0.05)(第 9-10 天至第 17-18 天阳性患者的百分比血清阳性)。危重症和非危重症患者 IgG 抗体血清转换时间无显著差异。

讨论

所有检测方法均在症状出现后 3 周内发生血清转换,与检测 IgG 或总 Ig 抗-N 的检测试剂盒相比,IgG 抗-S 的检测试剂盒的血清转换平均早 2 天。检测抗-N 的检测试剂盒的特异性与抗-S 相当,在具有挑战性的对照人群中表现出色。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8984/7834107/7a4297293475/gr1_lrg.jpg

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