Abstract：
BACKGROUND: Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission\'s In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures.
OBJECTIVE: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.
METHODS: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.
BACKGROUND: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.
CONCLUSIONS: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.
OBJECTIVE: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.
METHODS: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.
BACKGROUND: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.
CONCLUSIONS: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.
摘要：
背景：在您的实验室中可以常规使用新测试之前，它的可靠性必须在使用它的实验室中建立。国际标准要求新测试的验证和验证程序。国际标准化组织（ISO）15189最近更新，欧盟委员会的体外诊断条例（IVDR）生效。这些事件可能会增加对验证和验证程序的需求。
目的：本文旨在为验证或验证微生物学测试提供实践指导。包括临床微生物实验室的抗菌药物敏感性试验。
方法：它总结和解释了标准，如ISO15189:20222和法规，如IVDR2017/745。
背景：讨论了选择新测试的原因以及验证和验证计划的大纲。Further,涉及以下主题：参考标准的选择，样品数量,测试程序,如何解决新测试和参考标准的结果之间的差异，和验收标准。给出了选择某些参数（例如参考标准和样品大小）的参数和示例。
结论：由于实施IVDR，预期验证和验证程序会增加，本文可能有助于规划和执行这些程序。
目的：本文旨在为验证或验证微生物学测试提供实践指导。包括临床微生物实验室的抗菌药物敏感性试验。
方法：它总结和解释了标准，如ISO15189:20222和法规，如IVDR2017/745。
背景：讨论了选择新测试的原因以及验证和验证计划的大纲。Further,涉及以下主题：参考标准的选择，样品数量,测试程序,如何解决新测试和参考标准的结果之间的差异，和验收标准。给出了选择某些参数（例如参考标准和样品大小）的参数和示例。
结论：由于实施IVDR，预期验证和验证程序会增加，本文可能有助于规划和执行这些程序。
