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Proficiency test for rabies serology: A design complying with international standards for a reliable assessment of participating laboratories.
PLOS Neglected Tropical Diseases ( IF 3.8 ) Pub Date : 2019-12-11 , DOI: 10.1371/journal.pntd.0007824
Marine Wasniewski 1 , Michel Laurentie 2 , Franca Rizzo 1 , Alexandre Servat 1 , Michel Aubert 3 , Florence Cliquet 1
Affiliation  

BACKGROUND Domestic carnivores can introduce rabies into disease-free countries or areas if they are incubating the disease and transported during the pre-symptomatic period. For pets moved into the European Union, the European Commission decided to establish a system of community approval of laboratories willing to carry out the rabies serological controls to guarantee an effective control system. As the specific institute to coordinate the approval of the laboratories, designated by the European Commission in 2000, our laboratory organizes annual proficiency tests (PT) for laboratories already agreed or willing to be agreed to perform rabies serological controls (by detecting rabies virus neutralizing antibodies only) in the frame of international trade. METHODOLOGY/PRINCIPAL FINDINGS The assessment criteria of this PT rely on the analysis of the specificity and the intra-laboratory consistency. The approach used to evaluate the degree of laboratory consistency is based on the use of compiled data obtained from previous PT campaigns, and is measured by the quality of a regression model. By using historical data for calculating assigned values and associated standard deviations, instead of values obtained from only one campaign, they became robust without any additional statistical treatment. In the present paper, more than 800 historical values were compiled for each of the regression parameters. CONCLUSIONS/SIGNIFICANCE Since the beginning of these PT schemes in 1999, the overall percentage of failing laboratories remained stable over the years (4.1%) while the number of participants increased to 79 in 2018. This highlighted the robustness and the consistency of the statistical analyses used to assess the laboratory's performance over the years. The improvements carried out and the consistency of our statistical analyses have resulted in the compliance of the rabies serology PT with the ISO/IEC 17043 and ISO 13528:2015 International Standards.

中文翻译:

狂犬病血清学能力测试:符合国际标准的设计,可对参与实验室进行可靠评估。

背景技术如果食肉动物在症状发生前就对其进行孵化和运输,则可以将狂犬病带入无病的国家或地区。对于进入欧盟的宠物,欧盟委员会决定建立愿意接受狂犬病血清学控制以确保有效控制系统的实验室的社区认可系统。作为协调欧洲委员会于2000年指定的实验室批准工作的专门机构,我们的实验室为已经同意或愿意同意进行狂犬病血清学控制的实验室(通过检测狂犬病病毒中和抗体)组织年度熟练度测试(PT)仅在国际贸易范围内)。方法学/主要发现该PT的评估标准取决于对特异性和实验室内部一致性的分析。用于评估实验室一致性程度的方法是基于对先前PT活动获得的汇总数据的使用,并通过回归模型的质量进行衡量。通过使用历史数据来计算分配的值和相关的标准偏差,而不是仅从一个活动中获得的值,它们就变得强大而无需任何其他统计处理。在本文中,为每个回归参数编辑了800多个历史值。结论/意义自1999年实施这些PT计划以来,多年来失败的实验室的总体百分比一直保持稳定(4。1%),而参加者的人数在2018年增加到79人。这突出了用于评估实验室多年来绩效的统计分析的稳健性和一致性。进行的改进和统计分析的一致性使狂犬病血清学PT符合ISO / IEC 17043和ISO 13528:2015国际标准。
更新日期:2019-12-11
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