Interlaboratory Evaluation of a Method for Quantification of Norovirus RNA as an Alternative Use for ISO 15216-1:2017 to Conduct Japan Baseline Survey of Oysters
Interlaboratory Evaluation of a Method for Quantification of Norovirus RNA as an Alternative Use for ISO 15216-1:2017 to Conduct Japan Baseline Survey of Oysters
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DOI：
10.1089/fpd.2020.2874
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发表时间：
2021-02-17
影响因子：
2.8
通讯作者：
Fukunaga, Yoko
中科院分区：
文献类型：
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作者：
Imamura, Saiki;Shibata, Shiori;Fukunaga, Yoko
在本研究中，我们旨在研究日本牡蛎中诺瓦克病毒定量的标准方法，以临时适应该方法作为ISO 15216-1:2017的替代方法，对日本牡蛎中诺瓦克病毒进行基线调查。为此目的，对日本食品中病毒检测标准化委员会提供的方法进行了实验室间研究，以确定日本使用的标准方法的性能特征。因此，日本使用的标准方法对牡蛎中诺如病毒GI和GII的理论定量限预计分别为1.92和1.85 log(10) copies/g。GI和GII的重复性标准偏差（Sr）分别为0.26和0.30 log(10) copies/g，重现性标准偏差（S-R）分别为0.47和0.44 log(10) copies/g。通过实验室间的研究，我们确定了几个临界点，以获得科学可靠的结果，采用日本的标准方法。其中，应用过程控制病毒的必要性是需要改进的最关键的一点。此外，有许多参与的实验室无法处理标准品的稀释，无法对测试样本中的病毒进行量化或检测。为了确保科学可靠的检测结果，应结合过程控制材料在该方法中的应用，考虑实验室的能力建设和能力测试的实施。假设本研究揭示的问题将得到解决，日本使用的标准方法将适用于日本对牡蛎中诺如病毒的基线调查，这将有助于欧盟领导的针对牡蛎中诺如病毒的国际行动。
In this study, we aimed to investigate the standard method used for quantification of norovirus in oysters in Japan for the provisional adaptation of the method as an alternative to ISO 15216-1:2017, to conduct a Japan baseline survey of norovirus in oysters. For this purpose, the method provided by the Japan Committee for Standardization of Virus Detection in Food was subjected to an interlaboratory study to determine the performance characteristics of the standard method used in Japan. As a result, the theoretical limit of quantification for norovirus GI and GII in oysters by the standard method used in Japan was expected to be 1.92 and 1.85 log(10) copies/g, respectively. The repeatability standard deviations (Sr) were 0.26 and 0.30 log(10) copies/g for GI and GII, respectively, and the reproducibility standard deviations (S-R) were 0.47 and 0.44 log(10) copies/g for GI and GII, respectively. Through the interlaboratory study, we specified several critical points to obtain scientifically reliable results by using the standard method used in Japan. Especially, necessity for application of using process control virus was the most crucial point that needed to be improved. In addition, there are many participating laboratories that could not handle dilution of standard and quantify or detect the viruses in the test samples. To ensure scientifically reliable test result, capacity building of laboratories and implementation of proficiency testing should be considered for future tasks in combination with an application of process control materials in the method. On the assumption that the problems revealed in this study will be solved, the standard method used in Japan would be suitable for use in Japan baseline survey of norovirus in oysters, which will contribute to the international action against norovirus in oysters, led by the EU.