生物样品分析方法验证中的交叉验证

摘要

目的:明确交叉验证在生物样品分析方法中的作用、地位和必要性.方法:参阅国际上有关方法学验证的指导原则及文献,总结分析方法交叉验证在生物样品分析中的重要性和必要性,并通过实例建立不同实验室生物样品分析中的交叉验证流程,探讨现有操作流程的局限性.结果与结论:交叉验证结果表明,不同实验室的分析结果存在一定差异,但是符合可接受标准.交叉验证在生物样品分析中具有重要意义,需要得到重视并建立完善的操作流程及考核标准.%OBJECTIVE: To confirm the role, status and necessity of cross validation in analytical method of biological sample. METHODS: Referring to guidance principle and literatures of international method validation, the importance and necessity of cross validation of analytical method in biological sample were analyzed and summarized. We developed the procedure of analytical method cross-validation base on the practical case. The limit of operational procedure was investigated. RESULTS&CONCLU-SION: Results of cross validation indicate that there is difference in analytical results among different laboratories while the difference is up to the acceptable criteria. Cross validation play an important role in biological sample analytical methods, great importance should be attached to it and the establishment of operational procedure and assessment standards.