NMI Natural and Medical Sciences Institute at the University of Tübingen, Reutlingen, Germany.
Department of Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany.
Infection. 2024 Apr;52(2):597-609. doi: 10.1007/s15010-024-02180-6. Epub 2024 Feb 8.
Respiratory syncytial virus (RSV) is one of the leading causes of severe respiratory disease in infants and adults. While vaccines and monoclonal therapeutic antibodies either are or will shortly become available, correlates of protection remain unclear. For this purpose, we developed an RSV multiplex immunoassay that analyses antibody titers toward the post-F, Nucleoprotein, and a diverse mix of G proteins.
A bead-based multiplex RSV immunoassay was developed, technically validated to standard FDA bioanalytical guidelines, and clinically validated using samples from human challenge studies. RSV antibody titers were then investigated in children aged under 2 and a population-based cohort.
Technical and clinical validation showed outstanding performance, while methodological developments enabled identification of the subtype of previous infections through use of the diverse G proteins for approximately 50% of samples. As a proof of concept to show the suitability of the assay in serosurveillance studies, we then evaluated titer decay and age-dependent antibody responses within population cohorts.
Overall, the developed assay shows robust performance, is scalable, provides additional information on infection subtype, and is therefore ideally suited to be used in future population cohort studies.
呼吸道合胞病毒（RSV）是导致婴儿和成人严重呼吸道疾病的主要原因之一。虽然疫苗和单克隆治疗性抗体已经或即将上市，但保护相关因素仍不清楚。为此，我们开发了一种 RSV 多重免疫分析方法，用于分析针对 F 后蛋白、核蛋白和多种 G 蛋白的抗体滴度。
开发了基于珠的 RSV 多重免疫分析方法，技术验证符合标准 FDA 生物分析指南，并使用人体挑战研究中的样本进行了临床验证。然后在年龄小于 2 岁的儿童和基于人群的队列中研究了 RSV 抗体滴度。
技术和临床验证显示出出色的性能，而方法学的发展使我们能够通过使用多样化的 G 蛋白来识别大约 50%样本的先前感染的亚型。作为该检测方法在血清学监测研究中适用性的概念验证，我们随后在人群队列中评估了滴度衰减和年龄相关的抗体反应。
总的来说，开发的检测方法具有出色的性能，可扩展，可提供有关感染亚型的额外信息，因此非常适合在未来的人群队列研究中使用。
