National Institute for Public Health and the Environment (RIVM), Centre for Zoonoses and Environmental Microbiology (Z&O), EURL-Salmonella, P.O. Box 1, 3720, BA, Bilthoven, The Netherlands.
National Institute for Public Health and the Environment (RIVM), Centre for Zoonoses and Environmental Microbiology (Z&O), EURL-Salmonella, P.O. Box 1, 3720, BA, Bilthoven, The Netherlands.
Int J Food Microbiol. 2019 Jan 2;288:3-12. doi: 10.1016/j.ijfoodmicro.2018.03.022. Epub 2018 May 12.
The European and International Standard method for the detection of Salmonella spp. in samples from the primary production stage, EN ISO 6579:2002/Amd.1:2007, was validated by an interlaboratory study in the frame of Mandate M/381, ordered by the European Commission and accepted by the European Standardisation Organisation (CEN). In addition to this study, results from two interlaboratory studies organised earlier by the European Union Reference Laboratory (EURL) for Salmonella were used for determination of the performance characteristics. Parallel to the performance evaluation for the Mandate, the revision of EN ISO 6579:2002 started. Part of this revision was the incorporation of the standardised method for detection of Salmonella in samples from the primary production stage (EN ISO 6579:2002/Amd.1:2007) and its performance characteristics in the new part 1 of EN ISO 6579. The 2002 version of EN ISO 6579 already contained performance characteristics for the detection of Salmonella in food samples, but LOD values (contamination level at which 50% of the samples are found positive) were not yet included. To be in line with the performance characteristics determined for detection of Salmonella spp. in samples from the primary production stage, LOD values for detection of Salmonella in food samples were calculated from the raw data of the validation studies performed in 2000. In this paper, the performance characteristics of EN ISO 6579-1:2017 are determined based not only on the results of the interlaboratory study carried out in 2013 under the Mandate, but also on several other interlaboratory studies. These performance characteristics consist of specificity, sensitivity and LOD.
欧盟和国际标准检测初级生产阶段样品中沙门氏菌 spp. 的方法,即 EN ISO 6579:2002/Amd.1:2007,在欧盟委员会下达的任务 M/381 框架内进行了实验室间研究,并得到了欧洲标准化组织(CEN)的认可。除了这项研究,还使用了欧盟参考实验室(EURL)更早组织的两项沙门氏菌实验室间研究的结果来确定性能特征。在为任务进行性能评估的同时,也开始修订 EN ISO 6579:2002。修订的一部分是将初级生产阶段样品中沙门氏菌检测的标准化方法(EN ISO 6579:2002/Amd.1:2007)及其性能特征纳入新的 EN ISO 6579 第 1 部分。2002 年版的 EN ISO 6579 已经包含了食品样品中检测沙门氏菌的性能特征,但尚未包含 LOD 值(污染水平,在此水平下 50%的样品呈阳性)。为了与初级生产阶段样品中检测沙门氏菌 spp. 的性能特征保持一致,从 2000 年进行的验证研究的原始数据中计算了食品样品中检测沙门氏菌的 LOD 值。在本文中,不仅基于在 2013 年任务下进行的实验室间研究的结果,还基于其他几项实验室间研究,确定了 EN ISO 6579-1:2017 的性能特征。这些性能特征包括特异性、敏感性和 LOD。