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目的:明确交叉验证在生物样品分析测试中的必要性,建立生物样品分析中两台分析测试仪器之间交叉验证的操作规程。方法:参阅国际上有关方法学确证的指导原则及文献,通过一定数量的外标样品和给药后样品在两台分析测试仪器上的分析结果,经过统计,判定是否符合交叉验证的可接受标准。结果:本实验中通过对28个样本量的样品分析,双机测试的结果符合标准,双机测试的数据可以合并使用。结论:生物样品分析中,需要双机测试结果数据合并的时候,需要进行交叉确证。
OBJECTIVE: To clarify the necessity of cross-validation in biological sample analysis and testing and to establish a procedure for cross-validation between two analytical and test instruments in biological sample analysis. Methods: Refer to the international guidelines and literature on methodological validation, through a number of external standard samples and after administration of the sample analysis results of two analytical instruments, through statistics, to determine whether it meets the acceptable standard of cross-validation . Results: In this experiment, the samples of 28 samples were analyzed. The results of the two-machine test met the standards and the data of the two-machine test could be combined. Conclusion: In biological sample analysis, cross-validation is needed when the data of dual-machine test results need to be combined.