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EU-Approved Rapid Tests for Bovine Spongiform Encephalopathy Detect Atypical Forms: A Study for Their Sensitivities

机译:欧盟批准的快速检测为牛海绵状脑病检测非典型形式:一种是研究它们的敏感性

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摘要

Since 2004 it become clear that atypical bovine spongiform encephalopthies (BSEs) exist in cattle. Whenever their detection has relied on active surveillance plans implemented in Europe since 2001 by rapid tests, the overall and inter-laboratory performance of these diagnostic systems in the detection of the atypical strains has not been studied thoroughly to date. To fill this gap, the present study reports on the analytical sensitivity of the EU-approved rapid tests for atypical L- and H-type and classical BSE in parallel. Each test was challenged with two dilution series, one created from a positive pool of the three BSE forms according to the EURL standard method of homogenate preparation (50% w/v) and the other as per the test kit manufacturer's instructions. Multilevel logistic models and simple logistic models with the rapid test as the only covariate were fitted for each BSE form analyzed as directed by the test manufacturer's dilution protocol. The same schemes, but excluding the BSE type, were then applied to compare test performance under the manufacturer's versus the water protocol. The IDEXX HerdChek ® BSE-scrapie short protocol test showed the highest sensitivity for all BSE forms. The IDEXX® HerdChek BSE-scrapie ultra short protocol, the Prionics® - Check WESTERN and the AJ Roboscreen® BetaPrion tests showed similar sensitivities, followed by the Roche® PrionScreen, the Bio-Rad® TeSeE™ SAP and the Prionics® - Check PrioSTRIP in descending order of analytical sensitivity. Despite these differences, the limit of detection of all seven rapid tests against the different classes of material set within a 2 log10 range of the best-performing test, thus meeting the European Food Safety Authority requirement for BSE surveillance purposes. These findings indicate that not many atypical cases would have been missed surveillance since 2001 which is important for further epidemiological interpretations of the sporadic character of atypical forms.
机译:自2004年以来,人们清楚地发现牛中存在非典型牛海绵状脑病(BSE)。自从2001年以来,只要通过快速测试在欧洲实施主动监视计划来进行检测,迄今为止,尚未对这些诊断系统在检测非典型菌株中的整体和实验室间性能进行深入研究。为了填补这一空白,本研究报告了欧盟批准的非典型L型和H型以及经典BSE并行快速检测的分析灵敏度。每个测试均受到两个稀释系列的挑战,一个稀释系列是根据EURL标准匀浆制备方法(50%w / v)从三种BSE形式的阳性混合物中产生的,另一个按照测试试剂盒制造商的说明进行。按照测试制造商的稀释方案的指示,对每种BSE形式均拟合了多级逻辑模型和简单逻辑模型,其中快速测试是唯一的协变量。然后采用相同的方案,但不包括BSE类型,以比较制造商和水方案下的测试性能。 IDEXX HerdChek®BSE-scrapie短协议测试显示了所有BSE形式的最高灵敏度。 IDEXX®HerdChek BSE-scrapie超短协议,Prionics®-Check WESTERN和AJRoboscreen®BetaPrion测试显示出相似的灵敏度,其次是Roche®PrionScreen,Bio-Rad®TeSeE™SAP和Prionics®-Check PrioSTRIP按分析灵敏度的降序排列。尽管存在这些差异,但在表现最佳的测试的2 log10范围内,针对不同类别的材料设置的所有七个快速测试的检测极限,从而满足了欧洲食品安全局对BSE监控的要求。这些发现表明,自2001年以来没有遗漏很多非典型病例,这对于进一步流行病学解释非典型形式的零星特征非常重要。

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