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Assessment of reproducibility of a VP7 Blocking ELISA diagnostic test for African horse sickness

机译:评估VP7阻断ELISA诊断测试对非洲马病的可重复性

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摘要

The laboratory diagnosis of African horse sickness (AHS) is important for: (a) demonstrating freedom from infection in a population, animals or products for trade (b) assessing the efficiency of eradication policies; (c) laboratory confirmation of clinical diagnosis; (d) estimating the prevalence of AHS infection; and (e) assessing postvaccination immune status of individual animals or populations. Although serological techniques play a secondary role in the confirmation of clinical cases, their use is very important for all the other purposes due to their high throughput, ease of use and good cost‐benefit ratio. The main objective of this study was to support the validation of AHS VP7 Blocking ELISA up to the Stage 3 of the World Animal Health Organization (OIE) assay validation pathway. To achieve this, a collaborative ring trial, which included all OIE Reference Laboratories and other AHS‐specialist diagnostic centres, was conducted in order to assess the diagnostic performance characteristics of the VP7 Blocking ELISA. In this trial, a panel of sera of different epidemiological origin and infection status was used. Through this comprehensive evaluation we can conclude that the VP7 Blocking ELISA satisfies the OIE requirements of reproducibility. The VP7 Blocking ELISA, in its commercial version is ready to enter Stage 4 of the validation pathway (Programme Implementation). Specifically, this will require testing the diagnostic performance of the assay using contemporary serum samples collected during control campaigns in endemic countries.
机译:非洲马病的实验室诊断对以下方面很重要:(a)证明其不受人口,动物或贸易产品感染的自由(b)评估消灭政策的效率; (c)实验室对临床诊断的确认; (d)估计AHS感染的发生率; (e)评估个别动物或种群的疫苗接种后免疫状况。尽管血清学技术在确诊临床病例中起次要作用,但是由于其高通量,易用性和良好的成本效益比,它们的使用对于所有其他目的非常重要。这项研究的主要目的是支持AHS VP7阻断ELISA的验证,直至世界动物卫生组织(OIE)分析验证途径的第3阶段。为实现此目的,进行了一项包括所有OIE参考实验室和其他AHS专家诊断中心在内的协作环试验,以评估VP7封闭ELISA的诊断性能特征。在该试验中,使用了一组不同流行病学起源和感染状况的血清。通过全面的评估,我们可以得出结论,VP7封闭ELISA满足OIE重现性要求。商用版本的VP7封闭ELISA准备进入验证途径的第4阶段(计划实施)。具体而言,这将需要使用在流行国家开展的控制运动中收集的当代血清样本来测试测定的诊断性能。

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