Pieri Massimo, Nicolai Eleonora, Nuccetelli Marzia, Sarubbi Serena, Tomassetti Flaminia, Pelagalli Martina, Minieri Marilena, Terrinoni Alessandro, Bernardini Sergio
Department of Experimental Medicine, University of Rome "Tor Vergata", Via Montpellier 1, 00133, Rome, Italy.
Department of Laboratory Medicine, "Tor Vergata" University Hospital, Viale Oxford 81, 00133, Rome, Italy.
Arch Virol. 2022 May;167(5):1285-1291. doi: 10.1007/s00705-022-05422-w. Epub 2022 Apr 2.
With the widespread use of coronavirus disease 2019 (COVID-19) vaccines, a rapid and reliable method to detect SARS-CoV-2 neutralizing antibodies (NAbs) is extremely important for monitoring vaccine effectiveness and immunity in the population. The purpose of this study was to evaluate the performance of the RapiRead™ reader and the TestNOW™ COVID-19 NAb rapid point-of-care (POC) test for quantitative measurement of antibodies against the spike protein receptor-binding domain of severe respiratory syndrome coronavirus 2 (SARS-CoV-2) in different biological matrices compared to chemiluminescence immunoassay (CLIA) methods. Ninety-four samples were collected and analyzed using a RapiRead™ reader and TestNOW™ COVID-19 NAb kits for detecting neutralizing antibodies, and then using two CLIAs. The data were compared statistically using the Kruskal-Wallis test for more than two groups or the Mann-Whitney test for two groups. Specificity and sensitivity were evaluated using a receiver operating characteristic (ROC) curve. Good correlation was observed between the rapid lateral flow immunoassay (LFIA) test system and both CLIA methods. RapiRead™ reader/TestNOW™ COVID-19 NAb vs. Maglumi: correlation coefficient (r) = 0.728 for all patients; r = 0.841 for vaccinated patients. RapiRead™ reader/TestNOW™ COVID-19 NAb vs. Mindray: r = 0.6394 in all patients; r = 0.8724 in vaccinated patients. The time stability of the POC serological test was also assessed considering two times of reading, 12 and 14 minutes. The data revealed no significant differences. The use of a RapiRead™ reader and TestNOW™ COVID-19 NAb assay is a quantitative, rapid, and valid method for detecting SARS-CoV-2 neutralizing antibodies and could be a useful tool for screening studies of SARS-CoV-2 infection and assessing the efficacy of vaccines in a non-laboratory context.
随着2019冠状病毒病（COVID-19）疫苗的广泛使用，一种快速可靠的检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）中和抗体（NAbs）的方法对于监测人群中的疫苗效力和免疫力极为重要。本研究的目的是评估RapiRead™ 读数仪和TestNOW™ COVID-19 NAb快速即时检测（POC）检测法在不同生物基质中针对SARS-CoV-2刺突蛋白受体结合域的抗体定量测量性能，并与化学发光免疫分析（CLIA）方法进行比较。收集了94份样本，使用RapiRead™ 读数仪和TestNOW™ COVID-19 NAb试剂盒检测中和抗体，然后使用两种CLIA方法进行分析。使用Kruskal-Wallis检验对多组数据进行统计学比较，使用Mann-Whitney检验对两组数据进行统计学比较。使用受试者工作特征（ROC）曲线评估特异性和敏感性。快速侧向流动免疫分析（LFIA）检测系统与两种CLIA方法之间均观察到良好的相关性。RapiRead™ 读数仪/TestNOW™ COVID-19 NAb与迈瑞：所有患者的相关系数（r）= 0.728；接种疫苗患者的r = 0.841。RapiRead™ 读数仪/TestNOW™ COVID-19 NAb与迈克：所有患者的r = 0.6394；接种疫苗患者的r = 0.8724。还考虑了12分钟和14分钟这两个读数时间点评估即时检测血清学检测的时间稳定性。数据显示无显著差异。使用RapiRead™ 读数仪和TestNOW™ COVID-19 NAb检测法是一种定量、快速且有效的检测SARS-CoV-2中和抗体的方法，并且可能成为在非实验室环境中进行SARS-CoV-2感染筛查研究和评估疫苗效力的有用工具。
