摘要
目的探讨基于生物学变异的质量规范在临床生化质控方案设计中的应用。方法按照Westgard等的报道方法对18个临床生化项目基于生物学变异不同水平质量目标对应的sigma值进行了计算。不精密度（C弼）的数据采用近6个月（2011年5月～10月）室内质控数据。偏倚（Bias）的数据采用该室参加Bio-Rad实验室间质控比对计划（Interlabo—ratory QC Program）中与对等组比较的最近（2011年10月）的偏倚数据。根据sigma值及质控方案性能选择合适的质量目标及质控方案。结果18个生化项目中，分别有7个、2个和6个项目选择了最佳、期望和最低水平的生物学变异的质量规范。Ca，CI和Na目前的性能不能满足最低水平生物学变异质量规范的要求，分别选择了CLIA，88和德国Rilibak质控指南的标准。结论应用基于生物学变异不同水平的质量规范，可以让临床清楚了解检测过程给实验结果带来的误差最大有多少，更有利于检测结果的临床应用。
Objective To study the application of quality specification based on biological variation in planning quality control strategy of clinical biochemistry. Methods According to the method reported by Westgard,Sigma scores of different goal based on biological variability were calculated in 18 biochemistry test items. The dates of imprecision（CV%） were collected from routine quality control last 6 months （from May 2011 to October 2011）. The dates of bias were collected from peer group in Interlaboratory QC Program of Bio-Rad in October 2011. The appropriate quality goal and quality control strategy were selected according to the Sigma scores and the performance of quality control strategy. Results The optimum,desirable and minimum quality specifications based on the biological variation were selected for 7,2 and 6 of 18 biochemistry test items, respectively. The current performance of Ca, Cl and Na cannot meet the minimum quality specification based on biological variation. The specifications of them were selected according to CLIA＇88 and German Rilibak,respectively. Conclusion Application of quality specification based on biological variation in different levels make the clinicians understand clearly the maximum error of the results caused by testing process. It will be conducive to the application of test results.
出处
《现代检验医学杂志》
CAS
2012年第1期151-153,157,共4页
Journal of Modern Laboratory Medicine
关键词
生物学变异
质量控制
质量规范
biological variation, quality control, quality specification
