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无金标准情况下商业 Neospora caninum 竞争 ELISA 的统计评估:在艾伯塔省野生麋鹿( Cervus elaphus )中的应用。

Statistical evaluation of a commercial Neospora caninum competitive ELISA in the absence of a gold standard: application to wild elk (Cervus elaphus) in Alberta.

机构信息

University of Calgary, Department of Production Animal Health, Faculty of Veterinary Medicine, 3330 Hospital Drive NW, Calgary, Alberta, T2N 4N1, Canada,

出版信息

Parasitol Res. 2014 Aug;113(8):2899-905. doi: 10.1007/s00436-014-3951-4. Epub 2014 May 27.

Abstract

Neospora caninum is an important abortive agent of domestic ruminants, but few diagnostic tools are available to reliably assess the exposure of wild cervid species such as elk (Cervus elaphus) to this pathogen, which limits our ability to understand their role in the life cycle of this parasite. In the absence of a gold standard test or panels of samples from individuals of known infection status, classical laboratory-based validation methods are not applicable. However, there are a number of statistical methods that can help in selecting an appropriate cut-off value and estimating the resulting diagnostic test performances. In this paper, the performance of a commercial competitive enzyme-linked immunosorbent assay (cELISA) on elk serum samples was evaluated with two statistical approaches: a mixture distribution model fitted to the cELISA results, and a Bayesian latent class analysis combining results from the cELISA and an indirect immuno-fluorescence antibody test. Both methods indicated that the commercial kit could be used on elk serum with the specifications recommended by the manufacturer. In particular, the optimal combination of sensitivity and specificity were obtained for a percentage of inhibition cutoff of 30%. The 95% probability interval of the proportion of elk exposed to N. caninum, adjusting for the sensitivity and specificity of this test in elk, was estimated between 1.3 and 7.4%. There was no association between the serological status of female elk and their pregnancy status. These results point out to the involvement of elk in a sylvatic cycle of N. caninum in this area.

摘要

刚地弓形虫是一种重要的家畜流产病原体,但很少有诊断工具可用于可靠地评估野生鹿科物种(如 elk,麋鹿)对这种病原体的暴露情况,这限制了我们了解它们在这种寄生虫生命周期中的作用的能力。在缺乏金标准测试或来自已知感染状态个体的样本面板的情况下,经典的基于实验室的验证方法不适用。但是,有许多统计方法可以帮助选择适当的截止值并估计由此产生的诊断测试性能。在本文中,使用两种统计方法评估了一种商业竞争酶联免疫吸附测定(cELISA)在麋鹿血清样本中的性能:拟合 cELISA 结果的混合分布模型,以及结合 cELISA 和间接免疫荧光抗体测试结果的贝叶斯潜在类别分析。这两种方法都表明,可以按照制造商推荐的规格在麋鹿血清上使用商业试剂盒。特别是,在抑制率截断值为 30%时,获得了最佳的灵敏度和特异性组合。在调整了该测试在麋鹿中的灵敏度和特异性后, elk 暴露于刚地弓形虫的比例的 95%概率区间估计在 1.3 到 7.4%之间。 elk 的血清学状态与怀孕状态之间没有关联。这些结果表明 elk 参与了该地区刚地弓形虫的森林循环。

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