肌氨酸氧化酶法及苦味酸法测定血清肌酐比较.docVIP

肌氨酸氧化酶法及苦味酸法测定血清肌酐比较 　【关键词】 肌酐；肌氨酸氧化酶法；苦味酸法；方法比较 　　［摘要］ 目的：评测肌氨酸氧化酶法和苦味酸法测定血清样本肌酐(Cre)的偏倚。 方法：依据美国国家临床实验室标准协会EP9A文件，每天取临床样本8份，分别用两种方法测定血清样本Cre含量，共测定5 d，记录结果，去除离群点，计算线性回归方程和相关系数，进行偏倚估计。结果:在测定患者新鲜非黄疸血清样本Cre时，肌氨酸氧化酶法和苦味酸法测定结果的预期相对偏倚在Cre浓度lt;100 μmol/L时，两种方法的预期偏倚≤-1.8%， 酶法的测定结果低于苦味酸法; 当Cre浓度gt;200 μmol/L时，两种方法的预期偏倚≥11.9%，酶法的测定结果高于苦味酸法，当Cre浓度gt;500 μmol/L时，两种方法的预期偏倚≥20.1%。结论：随血清Cre浓度上升，酶法和苦味酸法的测定结果的预期偏倚增加，临床实验室在换用不同仪器或试剂时必须对肌酐测定的不同方法建立不同的参考值范围。 　　 　　［关键词］ 肌酐；肌氨酸氧化酶法；苦味酸法；方法比较 　　Measurement of Serum Creatinine by Sarcosine Oxidase and Picric Acid MethodsComparison between Two Methods 　　Abstract: Objective To determine the bias between two methods for measuring the serum creatinine (CRE). Methods Following the protocol described by the NCCL approved guideline (method comparison and bias estimation using patient samples)， 40 patient samples were analyzed in 5 operating days， each sample was analyzed in duplicate by both enzymatic assay and Jaffe kinetic assay. The duplicates were assessed for each method within the same run. The coefficient of correlation was calculated and the bias between the two methods was calculated accordingly. Results The bias between the enzymatic assay and Jaffe kinetic assay were -1.8% at 100 μmol/L， 11.9% at 200 μmol/L and 20.1% at 500 μmol/L for creatinine. Conclusion The bias between the two methods increases as the concentration of the serum creatinine increases. New reference range for creatinine should be established when new instrument or new reagent is applied. 　　Key words：Creatinine；Sarcosine oxidase；Picric acid methods； Method comparison 　　血中的肌酐(Cre)由外源性和内源性两类组成，主要由肾小球滤过，肾小管基本不重吸收。内源性Cre由肌肉代谢产生，每天生成量相当衡定，在外源性Cre摄入量稳定的情况下，血液中Cre的浓度取决于肾小球的滤过功能。当肾实质受损时血中Cre浓度升高，这是检测肾小球滤过功能的重要指标。为评测肌氨酸氧化酶法(Y)和碱性苦味酸法(X)测定血清Cre的偏倚，依据美国国家实验室标准协会EP9A文件，分别测定样本中Cre含量进行比较，报道如下。 　　1　材料和方法 　　1.1　仪器　Olympus AU 640(日本)。 　　1.2　肌氨酸氧化酶法(四川省迈克)， 批号020305， 校准物为Roche公司Calibrator for automated systems批号759350， 质控物为RANDOX公司 ASSAYED HUMAN MULTI SERA 296UN/1 R1，R2，苦味酸法(四川迈克)， 批