基于生物学变异的质量规范对心脏标志物室内质控不精密度分析  

Coefficients Variation Analysis of Internal Quality Control for the National Cardiac Markers

作　　者：张妍[1] 王薇[1] 何法霖[1] 钟堃[1] 王治国[1] 

机构地区：[1]卫生部临床检验中心,北京100730

出　　处：《现代检验医学杂志》2014年第2期156-158,共3页Journal of Modern Laboratory Medicine

基　　金：北京市自然科学基金资助项目（7143182）.

摘　　要：目的 以基于生物学变异确定的允许不精密度,1/3TEa,1/4TEa作为质量规范,评价2012年4月份参加卫生部临检中心心肌损伤标志物的380家单位和脑钠肽/N末端脑钠肽140家单位的室间质评单位室内质控不精密度.方法 组织全国心肌损伤标志物和脑钠肽/N末端脑钠肽室间质评参加单位回报2012年4月份当月在控室内质控变异系数,对肌酸激酶（CK-MB）、肌红蛋白（Mb）、肌钙蛋白I（cTnI）、肌钙蛋白T（cTnT）、脑钠肽（BNP）和N末端前脑钠肽（NT-proBNP）7个检测项目（其中CK-MB项目,回报单位分别为μg/L和U/L,视为两个检测项目）2个批号的变异系数进行统计分析,判断室内变异系数小于基于生物学变异导出的不精密度（CV％）质量规范和1/3TEa,1/4TEa质量规范所占的比例.结果 以80％实验室变异系数小于质量规范作为判断标准,结果显示：只有cTn Ⅰ的1批号不能满足1/3TEa的要求;而要满足1/4TEa的要求只有NT-pro BNP的两个批号同时满足;对于最低标准所有项目都可以满足,对于适当标准只有CK-MB两个批号同时满足;目前还没有项目可以满足最佳标准.结论 目前,大多数实验室都可以满足1/3TEa的精密度要求和允许不精密度的最低标准,但还不能满足适当标准,说明我国实验室在精密度性能上还需要进一步提高.Objective To evaluate the coefficients of variation （CVs） of internal quality control that cardiac markers and BNP/NT-pro BNP by the quality specification that allowable imprecision from biological variation 1/3TEa and 1/4TEa in A- pril 2012. Methods Organized a national cardiac markers and BNP/NT-pro BNP of external quality assessment units to return the in-control CVs of internal quality control in April 2012, and analyzed six test items （CK-MB myoglobin troponin I myoglobin troponin T BNP NT pro BNP） and two lots＇ CVs statistically,and judged the proportion that CVs less than the quality specification that allowable imprecision from biological variation 1/3TEa and 1/4TEa. Results For 80% laboratory CVs less than the quality specification as a criterion. Results ：only one lot of myoglobin troponin I could not meet the require rnent of 1/3TEa. To meet the requirements of 1/4 TEa only two lots of NT-pro BNP to meet. All items could be met as a minimum standard,for appropriate standards only CK MB two lots meets simultaneously. At present,there was no item that can meet the best standards. Conclusion Most labs can meet the precision requirements of 1/3TEa and minimum standards of allowable imprecision, but do not meet adequate standards, the laboratory on the precision performance also needs to im prove.

关 键 词：变异系数 生物学变异 不精密度 心肌损伤标志物 

分 类 号：R446[医药卫生—诊断学]