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四种替代型病毒中和试验(sVNTs)与金标准检测方法的性能评估比较。

Performance evaluation of four surrogate Virus Neutralization Tests (sVNTs) in comparison to the gold standard test.

机构信息

Department of Experimental Medicine, University of Tor Vergata, 00133 Rome, Italy.

Department of Laboratory Medicine, Tor Vergata University Hospital, 00133 Rome, Italy.

出版信息

Front Biosci (Landmark Ed). 2022 Feb 21;27(2):74. doi: 10.31083/j.fbl2702074.

DOI:10.31083/j.fbl2702074
PMID:35227017
Abstract

BACKGROUND

Several commercial surrogate Virus Neutralization Tests (sVNTs) have been developed in the last year. Neutralizing anti-SARS-CoV-2 antibodies through interaction with Spike protein Receptor Binding Domain (S-RBD) can block the virus from entering and infecting host cells. However, there is a lack of information about the functional activity of SARS-CoV-2 antibodies that may be associated with protective responses. For these reasons, to counteract viral infection, the conventional virus neutralization test (VNT) is still considered the gold standard. The aim of this study was to contribute more and detailed information about sVNTs' performance, by determining the anti-SARS-CoV-2 neutralizing antibody concentration using four different commercial assays and then comparing the obtained data to VNT.

METHODS

Eighty-eight samples were tested using two chemiluminescence assays (Snibe and Mindray) and two ELISA assays (Euroimmun and Diesse). The antibody titers were subsequently detected and quantified by VNT.

RESULTS

The overall agreement between each sVNT and VNT was 95.45% for Euroimmun and 98.86% for Diesse, Mindray and Snibe. Additionally, we investigated whether the sVNTs were closer to the gold standard than traditional anti-SARS-CoV-2 antibody assays S-RBD or S1 based, finding a higher agreement mean value for sVNTs (98.01 ± 1.705% vs 95.45 ± 1.921%; < 0.05). Furthermore, Spearman's statistical analysis for the correlation of sVNT versus VNT showed r = 0.666 for Mindray; r = 0.696 for Diesse; r = 0.779 for Mindray and r = 0.810 for Euroimmun.

CONCLUSIONS

Our data revealed a good agreement between VNT and sVNTs. Despite the VNT still remains the gold standard, the sVNT might be a valuable tool for screening wider populations.

摘要

背景

在过去的一年中,已经开发出了几种商业替代病毒中和试验(sVNT)。通过与 Spike 蛋白受体结合域(S-RBD)的相互作用来中和抗 SARS-CoV-2 抗体,可以阻止病毒进入并感染宿主细胞。然而,对于可能与保护反应相关的 SARS-CoV-2 抗体的功能活性,我们知之甚少。出于这些原因,为了抵抗病毒感染,传统的病毒中和试验(VNT)仍然被认为是金标准。本研究旨在通过使用四种不同的商业检测方法来确定抗 SARS-CoV-2 中和抗体的浓度,从而提供有关 sVNT 性能的更多详细信息,并将获得的数据与 VNT 进行比较。

方法

使用两种化学发光测定法(Snibe 和 Mindray)和两种 ELISA 测定法(Euroimmun 和 Diesse)对 88 个样本进行了测试。随后通过 VNT 检测和定量抗体滴度。

结果

对于 Euroimmun 和对于 Diesse、Mindray 和 Snibe,每种 sVNT 与 VNT 的总体一致性分别为 95.45%和 98.86%。此外,我们还研究了 sVNT 是否比基于传统的 SARS-CoV-2 抗体测定法 S-RBD 或 S1 的金标准更接近,发现 sVNT 的一致性平均值更高(98.01 ± 1.705%比 95.45 ± 1.921%;<0.05)。此外,sVNT 与 VNT 的相关性的 Spearman 统计分析显示,Mindray 的 r = 0.666;Diesse 的 r = 0.696;Mindray 和 Euroimmun 的 r = 0.779;以及 Euroimmun 的 r = 0.810。

结论

我们的数据显示 VNT 和 sVNT 之间具有良好的一致性。尽管 VNT 仍然是金标准,但 sVNT 可能是筛选更广泛人群的有价值的工具。

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