呼吸道合胞病毒 (RSV) 是全球儿童和婴儿呼吸系统疾病的主要原因，但目前还没有获得许可的疫苗可以降低患病风险。目前至少有 16 种 RSV 候选疫苗处于临床开发阶段，其中许多候选疫苗旨在诱导强大的病毒中和免疫反应。RSV 中和抗体 (nAb) 介导的干预措施，例如静脉注射免疫球蛋白 (IVIG) 和帕利珠单抗，可针对 RSV 引起的严重下呼吸道疾病提供被动保护，从而验证 nAb 是保护的相关性。为了确定已证明其保护功效的候选疫苗的保护相关性，研究人员可以使用旨在测量 nAb 反应的分析。但是，没有标准的测量方法。

标准化 RSV 中和试验是更好地评估 nAb 对候选疫苗的反应的重要步骤。所有人都使用共同的参考标准使得比较不同候选疫苗的免疫原性变得可行。在疫苗开发的背景下，世卫组织第一个 RSV 抗血清 (RSV IS) 国际标准已被证明适用于协调用于测量人类 RSV/A 和 RSV/B 的 nAb 滴度的实验室和检测格式之间的结果。血清。

这篇综述描述了目前使用的各种 RSV 病毒中和检测格式，以及 RSV IS 在跨格式和跨实验室协调结果方面的重要性。它还概述了关键检测成分和数据分析的良好实践，以提高测量血清样本中 RSV nAb 滴度的质量和一致性。

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Respiratory syncytial virus (RSV) is a leading cause of respiratory illness among children and infants worldwide, yet no licensed vaccine exists to reduce the risk of disease. At least 16 RSV vaccine candidates are currently in clinical development and many are designed to induce robust virus neutralizing immune responses. RSV neutralizing antibody (nAb)-mediated interventions such as intravenous immunoglobulin (IVIG) and palivizumab provide passive protection against serious lower respiratory tract disease due to RSV, validating nAbs as a correlate of protection. To identify correlates of protection for vaccine candidates that have demonstrated their protective efficacy, an investigator can use assays designed to measure nAb responses. However, there is no standard method of measurement; individual laboratories have developed their own methods to measure the ability of nAbs to reduce the infectivity of a defined virus dose in a variety of cell lines, leading to establishment of the broad variety of RSV neutralization assay formats currently in use.

Standardizing the RSV neutralization assay is an essential step toward better assessment of nAb responses to vaccine candidates. Use of a common reference standard by all makes comparing the immunogenicity of different vaccine candidates feasible. In the context of vaccine development, the WHO 1st International Standard for Antiserum to RSV (RSV IS) has been shown to be suitable for harmonizing results across laboratories and assay formats used to measure nAb titers to RSV/A and RSV/B in human sera.

This review describes the broad variety of RSV virus neutralization assay formats currently in use and the importance of the RSV IS for harmonization of results across formats and across laboratories. It also outlines good practices for key assay components and data analysis to promote the quality and consistency of measuring RSV nAb titers in serum specimens.