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Indirect foot-and-mouth disease vaccine potency testing based on a serological alternative.

机译：基于血清学替代品的间接口蹄疫疫苗效价测试。

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Foot-and-mouth disease (FMD) vaccine potency testing has historically been performed by experimentally infecting vaccinated cattle. A few alternative approaches to the in vivo challenge test based on the correlation between serum titres of primo-vaccinated cattle and protection against infection have been proposed, but none have been accepted by the European Pharmacopoeia (Ph.Eur.) due to the lack of statistical power and the pooling of data over time. The present study addresses these issues and presents data of 150 cattle vaccinated according to Ph.Eur. standards. Four laboratories took part in the serological testing and different serological assays were used, including virus neutralisation assays and ELISA formats. Models correlating specific anti-FMD virus antibody titres to protection were built using logistic regression followed by Receiver Operating Characteristic (ROC) analysis. The best models accurately predicted the in vivo protection status in 80.0% of the cases. Although differences were observed between laboratories and assays used, the majority of antibody pass-levels, determined using ROC analysis, corresponded to at least 75.0% probability of protection. The indirect potency assessment procedure proposed is at least as precise (repeatability=65.8%, reproducibility=60.7%) as the in vivo test, can be standardised and results in a quantitative PD(50) value. The validity of the procedure was also demonstrated.
机译：口蹄疫（FMD）疫苗效价测试历史上是通过实验性感染牛疫苗进行的。已经提出了几种基于原始疫苗接种的牛的血清滴度与抗感染保护性之间相关性的体内攻击试验的替代方法，但由于缺乏欧洲药典（Ph.Eur。），因此尚未被接受。统计能力和随时间推移的数据汇总。本研究解决了这些问题，并提供了根据Ph.Eur疫苗接种的150头牛的数据。标准。四个实验室参加了血清学测试，并使用了不同的血清学检测方法，包括病毒中和检测方法和ELISA格式。使用Logistic回归，然后进行接收者操作特征（ROC）分析，建立了将特定抗FMD病毒抗体滴度与保护相关的模型。最佳模型可准确预测80.0％的病例的体内保护状态。尽管在实验室和所用测定法之间观察到差异，但使用ROC分析确定的大多数抗体通过水平对应于至少75.0％的保护概率。提出的间接效能评估程序至少与体内测试一样精确（可重复性= 65.8％，可重复性= 60.7％），可以标准化并得出定量的PD（50）值。还证明了该程序的有效性。

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