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用于检测新型冠状病毒2型中和抗体的简易侧向流动免疫分析方法的评估

Evaluation of Simple Lateral Flow Immunoassays for Detection of SARS-CoV-2 Neutralizing Antibodies.

作者信息

Nickel Olaf, Rockstroh Alexandra, Borte Stephan, Wolf Johannes

机构信息

Department of Laboratory Medicine, Hospital St. Georg, 04129 Leipzig, Germany.

Fraunhofer Institute for Cell Therapy and Immunology, 04103 Leipzig, Germany.

出版信息

Vaccines (Basel). 2022 Feb 23;10(3):347. doi: 10.3390/vaccines10030347.

DOI:10.3390/vaccines10030347
PMID:35334979
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8949379/
Abstract

Immunization for the generation of protective antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged to be highly effective in preventing hospital admission, need for intensive care treatment and high mortality in the current SARS-CoV-2 pandemic. Lateral flow immune assays (LFIAs) offer a simple and competitive option to monitor antibody production after vaccination. Here, we compared the diagnostic performance of three different lateral flow assays in detecting nucleocapsid protein (NP), S1 subunit (S1) and receptor binding domain (pseudo)-neutralizing antibodies (nRBD) in sera of 107 health care workers prior (V1), two weeks (V2) after first vaccination with BNT162b2 as well as three weeks (V3) and eight months later (V4). In sera at V1, overall specificity was >99%. At V3, LFIAs showed sensitivities between 98.1 and 100%. The comparison of S1 and nRBD LFIA with S1 ELISA and a focus reduction neutralization assay (FRNT) revealed high concordance at V3. Thus, the use of lateral flow immunoassays appears to have reasonable application in the short-term follow-up after vaccination for SARS-CoV-2.

摘要

在当前严重急性呼吸综合征冠状病毒2(SARS-CoV-2)大流行中,通过免疫接种产生针对SARS-CoV-2的保护性抗体已被证明在预防住院、重症监护治疗需求和高死亡率方面非常有效。侧向流动免疫分析(LFIA)为监测疫苗接种后的抗体产生提供了一种简单且有竞争力的选择。在此,我们比较了三种不同侧向流动分析方法在检测107名医护人员血清中的核衣壳蛋白(NP)、S1亚基(S1)和受体结合域(假)中和抗体(nRBD)方面的诊断性能,这些医护人员在首次接种BNT162b2之前(V1)、接种后两周(V2)、三周(V3)以及八个月后(V4)。在V1时的血清中,总体特异性>99%。在V3时,LFIA显示出98.1%至100%的灵敏度。将S1和nRBD LFIA与S1酶联免疫吸附测定(ELISA)以及焦点减少中和试验(FRNT)进行比较,发现在V3时具有高度一致性。因此,侧向流动免疫分析在SARS-CoV-2疫苗接种后的短期随访中似乎具有合理的应用价值。

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