Betts R P, Rentenaar I M
Campden & Chorleywood Food Research Association, Chipping Campden, Gloucestershire, UK.
J Food Prot. 1998 Nov;61(11):1579-82. doi: 10.4315/0362-028x-61.11.1579.
In recent years, food microbiologists have seen the development of a range of nonstandard methods designed to enumerate or determine the presence of various microorganisms in food products. Generally the new methods are designed to give the microbiologist advantages, such as greater automation or faster results, over standard conventional methods. The new methods, however, have often not been thoroughly tested to give the end user confidence in the results. In order to generate data to show that new methods give results that are comparable with standard methods, they must be validated. A number of validation schemes have been developed in various countries throughout the world. There has not, however, been an acceptable scheme recognized throughout Europe. The MicroVal project has been involved in the development of a European microbiological method validation and certification scheme; it involves 21 partners from 7 EU member states. New methods that are tested by the MicroVal system will undergo initial testing in a single expert laboratory, to establish the test's specificity, limit of detection, relative accuracy, sensitivity, and linearity. This testing will be followed by a collaborative study in a minimum of eight laboratories, which will be used to determine the test precision, repeatability, and reproducibility. All results will be assessed by two expert reviewers who will recommend or reject the test. Tests that are recommended will be finally accepted by a MicroVal committee. The committee will pass its comments to one of several certification bodies (working together through a memorandum of understanding) who will certify that the new method gives results that are equivalent to the reference method used throughout the validation work. The technical rules that describe the work required to certify a method are currently being considered by the European Committee for Standardisation (CEN), with the objective that the rules will become a CEN standard for the certification of new test methods. When this objective has been achieved the rules will become an International Standards Organisation (ISO) standard for new test method validation.
近年来，食品微生物学家见证了一系列非标准方法的发展，这些方法旨在对食品中的各种微生物进行计数或确定其存在情况。一般来说，新方法旨在为微生物学家提供优于标准传统方法的优势，例如更高的自动化程度或更快的结果。然而，新方法往往没有经过充分测试，无法让最终用户对结果有信心。为了生成数据以表明新方法的结果与标准方法相当，它们必须经过验证。世界各国已经制定了一些验证方案。然而，整个欧洲尚未有一个被认可的可接受方案。MicroVal项目参与了欧洲微生物方法验证和认证方案的制定；它涉及来自7个欧盟成员国的21个合作伙伴。由MicroVal系统测试的新方法将首先在一个专家实验室进行初步测试，以确定测试的特异性、检测限、相对准确性、灵敏度和线性度。在此测试之后，将在至少八个实验室进行协作研究，用于确定测试的精密度、重复性和再现性。所有结果将由两名专家评审员评估，他们将推荐或拒绝该测试。被推荐的测试最终将由MicroVal委员会接受。该委员会将把其意见传达给几个认证机构之一（通过谅解备忘录共同合作），这些认证机构将证明新方法的结果与整个验证工作中使用的参考方法相当。描述认证一种方法所需工作的技术规则目前正由欧洲标准化委员会（CEN）审议，目标是这些规则将成为新测试方法认证的CEN标准。当这一目标实现时，这些规则将成为国际标准化组织（ISO）新测试方法验证的标准。
