临床检验参考区间的转换和验证  

Transformation and Validation of Reference Intervals

作　　者：钟堃[1] 王治国[1] 王薇[1] 李少男[1] 白玉[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心,北京100730

出　　处：《现代检验医学杂志》2011年第4期140-143,共4页Journal of Modern Laboratory Medicine

摘　　要：目的为实际工作中既定参考区问的转换以及已建立参考区间的验证提供帮助和建议。方法参考国外相关领域文献，结合中国实际情况完成该次研究。结果参考区同的转换和验证是实验室确定所用参考区间的两种推荐方法。参考区间转换的明显优点是不需要分析参考个体样本，但只适用于相关参考区间已使用的机构。当一家实验室想要采用生产商提供的或具有相同或相似分析系统的另一家实验室所使用的参考区间时，可以对已建立的参考区间进行验证。如果经过充分调查研究及进一步验证后无法采用该参考区同，建议实验室应该考虑建立自己的参考区间。结论大多数实验室没有能力也没有必要建立自己的参考区间，可以通过转换和验证其他参考区间来达到目的。Objective To providing helps and suggestions for transferring and validating an established reference intervals in practical work. Methods Referring to the articles in this field and according to Chinese current situation complete this study. Results Two recommended methods for ensuring the reference intervals in laboratories daily work were transferring and validating established reference intervals. The obvious advantage of transferring established reference intervals was no need to analyses reference individual samples ,hut this method had limited application because it only applies if the reference interval in question had been in use at that particular institution. Validation of an established reference interval was appropriate when a laboratory wishes to adopt an established reference interval supplied by a manufacturer or another laboratory for the same or similar analytical system. If after full investigation and further validation study the problem remains unresolved ,guidelines suggest that the laboratory should consider establishing its own reference interval. Conclusion Most laboratories do not had abilities and need not to establish their own reference intervals while we could transfer and validate other established reference intervals for alternating.

关 键 词：参考区间 转换 验证 

分 类 号：R446[医药卫生—诊断学]