全国干化学检测项目室内质控变异系数的调查和分析  

Investigation and analysis on the coefficients of variation of internal quality control for dry chemistry tests in China

作　　者：李国华[1] 王薇[1] 何法霖[1] 钟堃[1] 张妍[1] 赵彦[1] 王治国[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：《检验医学》2015年第4期381-385,共5页Laboratory Medicine

基　　金：北京市自然科学基金资助项目(7143182)

摘　　要：目的：通过调查2014年全国374家实验室上报的干化学检测项目室内质控数据，以生物学变异导出的质量规范和我国卫生行业标准WS／T 403-2012来分析我国各实验室不精密度水平。方法采用基于Web的室间质量评价软件系统，收集参加全国干化学室间质评项目的374家实验室2014年2月2个浓度（浓度1和浓度2）室内质控数据，包括钾、钠、氯、钙、磷、血糖、尿素、尿酸、肌酐、白蛋白、总蛋白、总胆固醇、甘油三酯、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、总胆红素、碱性磷酸酶、淀粉酶、肌酸激酶、乳酸脱氢酶、镁、γ-谷氨酰基转移酶22个检测项目的室内质控变异系数（ CV）。应用（ CLinetlab IQC） V3．0计算室内质控CV通过率来反映各实验室检测系统的不精密度水平能否满足规定的质量要求。结果结合浓度1和浓度2水平，对基于生物学变异导出的允许不精密度来说，尿素、尿酸、甘油三酯、总胆红素、丙氨酸氨基转移酶、肌酸激酶、γ-谷氨酰基转移酶7个项目比较满意，满足生物学变异“适当标准”的实验室比例均在92％以上，95％以上的实验室均能满足“最低标准”，满足“最佳标准”的实验室也能大约占到60％以上。血糖、总胆固醇、钾、磷、天门冬氨酸氨基转移酶、淀粉酶、乳酸脱氢酶7个项目基本满意，满足生物学变异“适当标准”的实验室基本在60％-90％之间，满足生物学变异“最低标准”的实验室均能在87％以上，而满足“最佳标准”的实验室数相对较低，在5．70％-69．74％之间。然而，钠、氯、钙、总蛋白、白蛋白、镁6个检测项目满足“适当标准”的实验室就极少。以我国卫生行业标准WS／T 403-2012质量规范为标准，各实验室精密度水平较好，基本在47％-70％之间。结论从统计的室内质控数据看，不同的检测项目满足允许不精Objective To investigate the imprecision level of dry chemistry tests in China through analyzing the internal quality control data of dry chemistry tests reported by 374 laboratories in 2014 according to the specifications based on biological variation and the health industry standard WS /T 403-2012 of China.Methods Web-based external quality assessment system was used to collect internal quality control data of 2 concentrations （ concentration 1 and concentration 2） of dry chemistry tests from 374 laboratories in February 2014, including the internal quality control coefficients of variation （CV） of 22 items, potassium, sodium, chloride, calcium, phosphorus, blood glucose, urea, uric acid, creatinine, total protein, albumin, total cholesterol, triglyceride, alanine aminotransferase , aspartate aminotransferase, total bilirubin, alkaline phosphatase, amylase, creatine kinase, lactate dehydrogenase, magnesium and gamma-glutamyltransferase.CLinetlab IQC V3.0 were applied for data processing .The percentages of laboratories meeting the quality requirements were calculated to reflect whether the imprecision of different test systems can meet the quality requirements.Results Combined with the concentrations of 1 and 2, for the results according to the specifications based on biological variation , seven projects such as urea, uric acid, triglyceride, total bilirubin, alanine aminotransferase , creatine kinase and gamma-glutamyltransferase were quite satisfied . Laboratories meeting the specifications based on biological variation including the desirable , minimal and optimal allowable imprecisions were above 92%, 95% and 60%, respectively. Blood glucose, total cholesterol, potassium, phosphorus, aspartate＆amp;nbsp;aminotransferase , amylase and lactate dehydrogenase were basically satisfied , laboratories who met the desirable allowable imprecision accounted for 60%to 90%, more than 87% laboratories met the minimal specification , but the percentages who met the optimal specification was relatively low which

关 键 词：不精密度 室内质控 干化学 变异系数 生物学变异 行业标准 

分 类 号：R446.1[医药卫生—诊断学]