测量不确定度在临床生化检验中的应用

目的对测量不确定度在临床生化检验中的应用进行研究分析。方法使用日立7080型的生化分析仪以及其配套的试剂;相关试验的校准品、定值质控品、室内质控品都为Roche品牌产品。K+、Cl-、Na+、Ca2+采用间接选择的电极法;丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)和谷氨酰转肽酶(GGT)则采用速率法;总蛋白(TP)采用双缩脲的终点法;清蛋白(Alb)采用溴甲酚绿显示终点法;磷(P4+)则采用磷钼酸的紫外法;尿素氮(BUN)、肌酐(Cr)为酶法;尿酸(UA)采用尿酸酶比色法;葡萄糖(Glu)则为氧化酶法;而胆固醇(Ch)则采用胆固醇氧化酶的方法;三酰甘油(TG)采用GPO-PAP酶法。结果各指标测量的不确定度:TP为2.93%,Alb为7.21%,GGT为14.20%,AST为11.71%,ALT为12.80%,ALP为8.22%,Na+为1.34%,K+为2.38%,Cl-为2.65%,Ca2+为4.17%,P4+为4.00%,BUN为9.17%,Cr为9.34%,UA为13.72%,GLU为4.06%,Ch为3.87%。结论不确定度评估的一个重要前提就是实验室内必须具备一系列行之有效的控制措施以及质量保证体系,才能够确保过程中的稳定以及在控。

In the measurement uncertainty of clinical biochemical examination application analysis

Objective To analyze measurement uncertainty of clinical biochemical examination application.Methods Hitachi 7080 biochemical analyzer and its matching reagents were used.Experimental calibration products,set the value of the quality control,indoor quality control substance were Roche products.K＋,Cl-,Na＋,Ca2＋ were used indirect selective electrode method to detect.GGT and AST,ALT,ALP were used the rate method.Total protein（TP） was used biuret end point method.Albumin（Alb） was used bromocresol purple display terminal method.Phosphorus（P4＋） was used Phosphomolybdic Acid UV method.Blood urea nitrogen（BUN）,creatinine（Cr） were used electrode.Uric acid（UA） was used enzymatic colorimetric method.Glucose（Glu）,and cholesterol were used oxidase methods.（Ch） was used cholesterol oxidase method.Triglyceride（TG）was used the GPO-PAP enzyme method.Results The measurement uncertainty：total protein was 2.93%,albumin was 7.21%,GGT was 14.20%,aspartate transaminase was 11.71%,alanine aminotransferase was 12.80%,alkaline phosphatase was 8.22%,Na＋ was 1.34%,K＋ was 2.38%,CI-was 2.65%,Ca2＋ was 4.17%,P4＋ was 4.00%,BUN is 9.17%,urea nitrogen was 9.34%,creatinine uric acid was 13.72%,glucose was 4.06%,cholesterol was 3.87%.Conclusion Uncertainty（U%） assessment has an important premise in laboratory that must have effective control measures and quality assurance system to ensure the stability and control in the process.