Classical swine fever (CSF) marker vaccine - Trial III. Evaluation of discriminatory ELISAs
Classical swine fever (CSF) marker vaccine - Trial III. Evaluation of discriminatory ELISAs
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DOI：
10.1016/s0378-1135(01)00411-4
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发表时间：
2001-11-08
影响因子：
3.3
通讯作者：
Floegel-Niesmann, G
中科院分区：
文献类型：
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作者：
Floegel-Niesmann, G
标记疫苗试验的目的是在野外可能发生的情况下测试两种可用的CSF标记疫苗，并评估歧视性试验的可靠性。对歧视性检验的评价特别重要，因为设在伦敦的欧洲医药产品评价局（EMEA）不要求提供有关其执行情况的正式数据。EMEA负责欧盟范围内标记疫苗的许可程序。16个国家猪瘟实验室（NSFL）参与了特异性elisa检测。对它们进行了敏感性、特异性、重复性和实用性测试。参考血清（CSFV和BVDV抗体阳性）和现场血清以及标记疫苗试验期间产生的断奶仔猪和母猪试验血清。两种歧视性elisa都不如传统的CSF抗体elisa敏感，尽管它们之间存在相当大的差异。两种歧视性ELISA的特异性均较低，但敏感性较高，反之亦然。两种歧视性ELISA都不能准确地将接种了CSF的断奶猪正确地检测为“CSF阳性”，尽管CSF感染的妊娠母猪被正确地识别出来。试验中使用的歧视性elisa的局限性是阻止在紧急现场条件下使用这两种标记疫苗的主要因素。(C) 2001 Elsevier Science B.V.版权所有
The objective of the marker vaccine trial was to test the two available CSF marker vaccines in scenarios which are likely to occur in the field and to evaluate the reliability of the discriminatory tests. The evaluation of the discriminatory tests was of special importance because there is no requirement for formal data concerning their performance by the European Medicinal Products Evaluation Agency (EMEA) in London. EMEA is responsible for the licensing procedure of the marker vaccines within the EU. Sixteen National Swine Fever Laboratories (NSFL) participated in testing the discriminatory ELISAs. They were tested for sensitivity, specificity, reproducibility and practicability. Reference sera (CSFV and BVDV antibody positive) and field sera were used as well as sera from the weaner and sow experiments produced during the marker vaccine trial. Both discriminatory ELISAs were less sensitive than conventional CSF antibody ELISAs, although there was considerable variation between them.Both discriminatory ELISA was less specific than the other, but more sensitive, and vice versa. Neither discriminatory ELISA consistently detected the marker-vaccinated, CSF-cballenged weaner pigs correctly as 'CSF positive', although CSF-challenged pregnant sows were identified correctly. The limitations of the discriminatory ELISAs used in the trial was the major factor that would prevent the use of these two marker vaccines under emergency field conditions. (C) 2001 Elsevier Science B.V. All rights reserved.