French Agency for Food, Environmental and Occupational Health & Safety (ANSES), Nancy Laboratory for Rabies and Wildlife, European Union Reference Laboratory for Rabies, European Union Reference Laboratory for Rabies Serology, WHO Collaborating centre for Research & Management in Zoonoses Control, OIE Reference Laboratory for Rabies, Technopôle agricole et vétérinaire, BP 40 009, 54 220 Malzéville Cedex, France.
J Virol Methods. 2014 Jan;195:211-20. doi: 10.1016/j.jviromet.2013.10.021. Epub 2013 Oct 23.
For several years, international movements with pets have greatly increased. Most countries have relaxed their quarantine measures and adopted a scheme combining vaccination of pets against rabies followed by a serological test to check the efficacy of vaccination. This new scheme has been strongly supported by the OIE, WHO and the European Commission to facilitate the free movement of people and pets around the world. Currently, only two reference methods are recognised and prescribed (the FAVN test and the RFFIT) to measure rabies antibody levels in serum samples for international trade. They are reliable and valuable methods of assessing the efficacy of rabies vaccination but they are time-consuming and require well-trained people and specialised laboratory facilities. A few years ago, an ELISA (Platelia™ Rabies II kit ad usum Veterinarium) was developed for domestic carnivores and wildlife. To our knowledge, this ELISA is the only one certified and prescribed by the OIE. Following its marketing, one task of the EURL for rabies serology was to evaluate the performance of laboratories using this new kit. The results revealed that 26% of the participants, which were already approved laboratories for rabies serology, failed the inter-laboratory trial. Such unsatisfactory results have never been observed during any of the previous proficiency tests organised annually since 2000 by the EURL for rabies serology using reference methods. More investigations were undertaken through internal and collaborative studies to assess the performance of this newly marketed ELISA kit. The results of the internal study revealed that even with a specificity of 100%, the sensitivity evaluated on 593 samples of domestic carnivores came to 78.2%. An issue regarding the underestimation of serum titres was also revealed during the study. The results of a collaborative study involving 23 international laboratories reinforced the preliminary conclusions regarding lack of sensitivity. Indeed, only 5 laboratories out of the 23 obtained satisfactory results. We therefore suggest adopting a threshold of 0.3 EU/mL instead of 0.5 EU/mL to increase the sensitivity of the test.
多年来，携带宠物的国际旅行大幅增加。大多数国家已经放宽了隔离措施，并采用了一种将宠物接种狂犬病疫苗与随后的血清学检测相结合的方案，以检查疫苗接种的效果。国际兽疫局、世界卫生组织和欧盟委员会强烈支持这一新方案，以促进世界各地人员和宠物的自由流动。目前，只有两种公认和规定的参考方法（FAVN 检测和 RFFIT）用于测量血清样本中的狂犬病抗体水平，以便进行国际贸易。这些方法是评估狂犬病疫苗效果的可靠和有价值的方法，但它们耗时且需要经过良好培训的人员和专门的实验室设施。几年前，开发了一种用于家养食肉动物和野生动物的 ELISA（Platelia™ Rabies II 试剂盒用于兽医）。据我们所知，这是唯一一种经国际兽疫局认证和规定的 ELISA。在上市后，狂犬病血清学参考实验室的一项任务是评估使用该新试剂盒的实验室的性能。结果显示，26%的参与者，即已经获得狂犬病血清学实验室认可的实验室，未能通过实验室间试验。自 2000 年以来，狂犬病血清学参考实验室每年组织的能力验证试验中从未观察到如此不理想的结果。通过内部和合作研究进行了更多的调查，以评估新上市的 ELISA 试剂盒的性能。内部研究的结果表明，即使特异性为 100%，在对 593 份家养食肉动物样本进行评估时，敏感性也仅为 78.2%。在研究过程中还发现了血清效价低估的问题。涉及 23 个国际实验室的合作研究结果证实了敏感性不足的初步结论。实际上，23 个实验室中只有 5 个获得了满意的结果。因此，我们建议将检测的敏感性阈值从 0.5 EU/mL 提高到 0.3 EU/mL。
