3种淀粉酶测定方法的应用评价  

Three kinds of amylase determination method of application evaluation

作　　者：蒋晓军[1] 罗甫花[1] 王朝燕[1] 

机构地区：[1]湖南省邵阳市第一人民医院检验科,422001

出　　处：《检验医学与临床》2012年第6期661-662,664,共3页Laboratory Medicine and Clinic

摘　　要：目的对常用的几种淀粉酶(AMY)测定方法进行临床应用评价。方法依照美国实验室标准化委员会(CLSI)EP7-A2、EP9-A2文件对3种方法(EPS法、CNPG3法和麦芽四糖法即贝克曼专用试剂)的精密度、比对试验和偏倚评估、线性分析及干扰试验进行测试。结果 3种淀粉酶测定方法的日内精密度小于1/4总分析误差,日间精密度小于1/3总分析误差。以EPS法为比较方法(X),CNPG3法与贝克曼专用试剂为实验方法(Y),用临床标本作比对分析,相关系数(r)分别为0.999和0.998,贝克曼专用试剂在3个医学决定水平(XC=50、120、200)处相对偏差分别为28.42%、18.35%、15.48%。CNPG3法对高脂血的抗干扰能力较EPS法与贝克曼专用试剂要高,但对混有较多红细胞的样品会出现假性增高;EPS法的线性较CNPG3法和贝克曼专用试剂要高。结论 3种方法的相关性较好,贝克曼专用试剂存在偏差,可进行一定修正。3种方法的线性与抗高脂血的干扰都能满足临床要求,CNPG3法容易受到红细胞的干扰而使结果假性增高造成临床的误诊。Objective To investigate the value of clinical application evaluation methods of common amylase.Methods Using SPSS and Excel software in accordance with CLSI EP7-A2 and EP9-A2 document to test（including EPS method,CNPG3 law,the malt tetrasaccharide law the is the Beckmann special-purpose reagent） with the precision,comparison test and bias assessment,linear analysis and interference experiment.Results Three kinds of amylase method of intra-day precision less than 1/4 of total analytical error and inter-day precision was less than 1/3 of the total analytical error.EPS law was the comparison method（X）,the CNPG3 law and the Beckmann special-purpose reagent（Y） was the experimental technique with the clinical specimen compared to analyzes the correlation coefficient r=0.999 and r=0.998 respectively,the Beckmann special-purpose reagent in 3 medicine decision level（XC=50,120,200） place the relative deviation were 28.42%,18.35%,15.48% respectively.CNPG3 method in hyperlipidemic immunity was higher than the EPS method and beckman special reagent,but mixed with red blood cell samples would appear more false increase.In the linear EPS method was higher than CNPG3 law and beckman reagents specific.Conclusion Three method′s relevance are good and there is a deviation in Beckman specific reagent,but it can be certain amendments.Three methods of linear interference and the anti-hyperlipidemia can meet clinical requirements,but CNPG3 law is vulnerable to interference from red blood cells caused by leaving the false increase and making the results of clinical misdiagnosis.

关 键 词：淀粉酶 EPS CNPG3 

分 类 号：R446.6[医药卫生—诊断学]