Department of Clinical Chemistry, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Department of Clinical Chemistry, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Clin Chim Acta. 2020 Nov;510:73-78. doi: 10.1016/j.cca.2020.07.007. Epub 2020 Jul 9.
For epidemiologic, social and economic reasons, assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prevalence and immunity are important to adapt decisions to current demands. Hence, immunoassays for detection of anti-SARS-CoV-2 antibodies are introduced rapidly without requiring FDA emergency use authorization approval. Thus, evaluation of test performance predominantly relies on laboratories. This study aimed to evaluate the test performance of recently launched commercial immunoassays in serum and plasma samples.
51 serum samples from 26 patients with confirmed SARS-CoV-2 infection after end of quarantine and 25 control patients were analyzed using anti-SARS-CoV-2 IgG immunoassays from Roche, Euroimmun and Epitope to assess diagnostic sensitivity and specificity. 20 matching pairs of serum and plasma samples were included to analyze comparability between different specimens.
Overall, a diagnostic sensitivity of 92.3%, 96.2-100% and 100% with a respective diagnostic specificity of 100%, 100% and 84-86% for the immunoassays from Roche, Euroimmun and Epitope were determined. In total, 84-96% of samples were correctly classified as negative and 92.3-95.2% as positive. The level of concordance between plasma- and serum-based testing diverged between the assays (Epitope r = 0.97; Euroimmun r = 0.91; Roche r = 0.76).
The immunoassays from Euroimmun and Roche revealed a higher specificity than the Epitope assay without a substantial drop of diagnostic sensitivity. Significant differences between plasma- and serum-based testing highlights the need for determination of appropriate cut-offs per specimen type. Hence, there is an urgent need for test harmonization and establishment of quality standards for an appropriate use of COVID-19 serological tests.
出于流行病学、社会和经济方面的原因，评估严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染的流行率和免疫情况对于根据当前需求调整决策非常重要。因此，无需获得美国食品药品监督管理局（FDA）的紧急使用授权，即可快速推出用于检测抗 SARS-CoV-2 抗体的免疫测定法。因此，主要依靠实验室来评估检测性能。本研究旨在评估最近推出的商业免疫测定法在血清和血浆样本中的检测性能。
使用罗氏、欧蒙和 Epitope 的抗 SARS-CoV-2 IgG 免疫测定法分析了 51 份来自 26 名隔离期结束后确诊 SARS-CoV-2 感染的患者的血清样本和 25 名对照患者的血清样本，以评估诊断灵敏度和特异性。纳入了 20 对配对的血清和血浆样本，以分析不同标本之间的可比性。
总体而言，罗氏、欧蒙和 Epitope 免疫测定法的诊断灵敏度分别为 92.3%、96.2-100%和 100%，诊断特异性分别为 100%、100%和 84-86%。总的来说，84-96%的样本被正确归类为阴性，92.3-95.2%被归类为阳性。不同检测方法的血浆和血清检测之间的一致性程度存在差异（Epitope r=0.97；欧蒙 r=0.91；罗氏 r=0.76）。
欧蒙和罗氏的免疫测定法与 Epitope 测定法相比特异性更高，而诊断灵敏度没有明显下降。血浆和血清检测之间的显著差异突出表明，需要针对每种标本类型确定适当的临界值。因此，迫切需要进行检测协调并建立 COVID-19 血清学检测的质量标准，以确保其得到适当应用。
