不同仪器检测肌酐的线性调查  

Creatinine linear investigation in various assay instruments

作　　者：周琦[1] 徐建平[1] 谢伟[1] 李少男[1] 李小鹏[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心,100730

出　　处：《中华检验医学杂志》2010年第8期782-785,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的 调查不同仪器检测肌酐的线性,旨在评价临床实验室检测肌酐的能力.方法 利用美国临床和实验室标准协会（Clinical and Laboratory Standards Institute,CLSI）推荐的EP6-A指南,即多项式回归分析方法判断统计学标准的线性和非线性,利用Kroll医生对EP6-A补充的方法计算数据的不精密度和最优拟合曲线与直线的平均偏离值.按照分析仪器的不同将检测数据分为4组,即Beckman LX组（28家实验室）、Beckman CX组（14家实验室）、Hitachi组（62家实验室）和Olympus组（72家实验室）.结果 在Beckman LX组、Beckman CX组、Hitachi组和Olympus组,肌酐检测数据的不精密度范围分别是0.30%～3.01%、0.09%～3.46%、0.14%～4.91%和0.17%～16.44%,在Olympus组,有1家实验室检测数据的不精密度（16.44%）超过了设定值,其他实验室的检测数据具有作线性调查的精密度.最优拟合曲线与直线的平均偏离值的范围分别是0%～2.38%、0%～2.51%、0%～5.46%和0%～4.66%,统计学标准的线性分别占21.4%（6/28）、35.7%（5/14）、11.3%（7/62）和18.1%（13/72）,临床标准的线性分别占78.6%（22/28）、64.3%（9/14）、88.7%（55/62）和80.6%（58/72）.通过肌酐线性调查的实验室分别占100%（28/28）、100%（14/14）、100%（62/62）和98.6%（71/72）.结论 参加线性调查的实验室大部分具有检测肌酐的能力.Objective To investigate the linearity on testing creatinine in various assay instntments,in order to evaluate creatinine testing ability of clinical laboratories. Methods Statistically standard linearity and nonlinearity were judged via polynomial regression analysis recommended by EP6-A guideline. The imprecision of analytical data were analyzed and the average deviation of best fitting curve from linearity were determined by Dr. Kroll＇s EP6-A extended methods. In accordance with the instruments used, the testing data were divided into four groups： Beckman LX （28 Labs）, Beckman CX （ 14 Labs）, Hitachi （62 Labs）and Olympus （72 Labs） groups. Results This research found that in samples analyzed by Beckman LX,Beckman CX, Hitachi and Olympus instruments, the imprecision ranged from 0. 30%-3.01%, 0.09%-3.46%, 0. 14%-4. 91% and 0. 17% -16. 44%, respectively. The imprecision in one laboratory in Olympus group exceeded the acceptable limit, while the imprecision in the remaining laboratories were precision for linear survey. The average deviations of best fitting curve from linearity ranged from 0%-2. 38%, 0%-2. 51%, 0% -5.46% and 0% -4. 66%, respectively. The linearity with statistical significance were 21.4% （6/28）, 35.7% （5/14）, 11.3% （7/62） and 18. 1% （13/72）, respectively. The linearity with clinical significance were 78.6% （22/28）, 64. 3% （9/14）, 88. 7% （55/62） and 80. 6% （58/72）, respectively.The percentages of laboratories whose creatinine testing met the linearity criteria were 100% （28/28）,100% （ 14/14 ）, 100% （ 62/62 ） and 98. 6% （ 71/72 ）, respectively. Conclusion Majority of the laboratories involved in the linearity survey present good capability for creatinine testing.

关 键 词：肌酸酐 线性 回归分析 

分 类 号：R446.1[医药卫生—诊断学]