不同线性评价方法在临床化学测量中的应用

The application of different linear evaluation method for clinical chemistry measurement

目的探讨不同的线性评价方法在临床化学测量中的应用。方法运用目测法、改良Doumas法、《临床化学设备线性评价指南》(以下简称卫生行业标准法)及美国临床实验室标准化协会(CLSI)EP6-A文件(以下简称EP6-A法)对丙氨酸氨基转移酶(ALT)、肌酸激酶(CK)、葡萄糖(Glu)、尿素(Urea)、尿酸(UA)等测定项目进行分析测量范围的建立。结果目测法显示各项目的预期值和测量均值基本在一条直线上。改良Doumas法评价CK为非线性,舍弃最后两点评价为线性;其余项目评价为线性。卫生行业标准法评价CK、Urea为非线性,但不能判断其非线性是否为临床可接受;其余项目评价为线性。EP6-A法直接判断ALT、Glu、UA为线性;CK、Urea评价为临床可接受线性,舍弃最高值后评价为线性。结论 EP6-A文件标准将线性评价与临床目标相结合,通过设定方法学偏移,在临床可接受范围内扩大对分析方法呈线性的认可范围,更具临床实用性。

Objective To explore the application of different linear evaluation methods for clinical chemistry measurement.Methods The analytical measurement ranges of clinical common items,including alanine aminotransferase（ALT）,creatine kinase（CK）,glucose（Glu）,urea（Urea）and uric acid（UA）were established by using visual method,modified Doumas method,and according to′Guide to linearity evaluation of clinical chemistry analyzers′（health profession standard method）and Clinical and Laboratory Standards Institute（CLSI）EP6-A document（EP6-A method）.Results The visual method shown that the expected values and the measured values of these inspection items were probably in a straight line.The modified Doumas method shown that nonlinearity between expected values and measured values of CK was found,but linearity was evaluated when discarding the last two points;and the rest of inspection items all had linearity.The health profession standard method indicated that nonlinearities between expected values and measured values of CK and Urea were found,but could not determine whether the nonlinearities of the two items were clinically acceptable;and the rest of inspection items all had linearity.The EP6-A method shown that linearities were directly found between expected values and measured values of ALT,Glu and UA,while CK and Urea had clinical acceptable linearities and linearities were evaluated when discarding the maximum values.Conclusion The linearity evaluation is integrated with clinical objectives through EP6-A document.Through setting methodology allowable deviation,the EP6-A method could expand the scope of accredition of linearity within the clinical acceptable range,which has higher clinical practicability.