循环酶法测定同型半胱氨酸试剂盒评价  

Evaluation of the Enzymatic Cycling Homocysteine Assay Kit

作　　者：王兴宁[1] 雷光星[1] 李慧[1] 惠玉芬[1] 

机构地区：[1]延安大学附属医院检验科,陕西延安716000

出　　处：《标记免疫分析与临床》2014年第3期318-320,共3页Labeled Immunoassays and Clinical Medicine

基　　金：国家高新技术研究发展计划(863计划)课题资助;课题编号:2011AA02A111

摘　　要：目的 选取北京九强、上海执诚、宁波瑞源生产的循环酶法同型半胱氨酸（Hcy）试剂盒,对其方法性能及临床实验室应用的要求进行评价.方法 据NCCLS颁布的的EP5-A、EP6-A和EP7-A评价方案对三个循环酶法Hcy测定试剂盒进行回收实验、干扰实验、线性及精密度评价.结果 九强、执诚、瑞源的循环酶法Hcy测定试剂盒高、低浓度的批内CV分别为3.2、2.4、1.2;3.7、3.8、1.8;总CV（％）分别为4.4、3.4、3.1;4.3、5.6、3.3.回收率97％ ～ 105％.相关系数分别为r=0.996、r=0.993、r=0.995.胆红素在500mg/L、抗坏血酸在500 mg/L、甘油三酯在8.88mmol/L内对九强和瑞源的试剂无明显干扰,相对偏差小于4％.胆红素在500 mg/L、抗坏血酸在500mg/L内对执诚的试剂无明显干扰,相对偏差小于4％;甘油三酯对该试剂有明显干扰,甘油三酯在8.88mmol/L时相对偏差为12.2％.结论 三种循环酶法Hcy测定试剂盒的抗干扰、线性范围及精密度等性能可满足临床检验的需要.Objective To evaluate the properties of select three kinds of enzymatic cycling Homocysteine assay kits and to determine whether the kits meets the requirements of the clinical laboratory Methods According to the evaluation program EP5-A,EP6-A and EP7-A by the NCCLS,three kinds of enzymatic cycling homocysteine （Hcy） assay kits made by Jiuqiang,Zhicheng and Ruiyuan company were evaluated with recovery test,interference test,linear test and precision test,respectively.Results The CVs of within-run at high and low level for Jiuqiang,Zhicheng and Ruiyuan company kits were 3.2,2.4,1.2,3.7,3.8 and 1.8 respectively,and the total precisions are 4.4,3.4,3.1,4.3,5.6 and 3.3 respectively.The recovery yield was 97% ～105%.The correlation coefficient were r =0.996、r =0.993、r =0.995,respectively.When the levels of bilirubin were at 500 mg/L or ascorbic acid at 500 mg/L,the interference deviation of the three kinds of kits was less than that 4%.When the level of triglyceride was at 8.88 mmol/L,the interference deviation of reagent of Jiuqiang and Ruiyuan was less than that 4%,but the reagent of Zhicheng was 12.2%.Conclusion The performance of interference,linearity and precision testing of the three kinds of enzymatic cycling Hcy assay kits can meet the requirements of clinical laboratory.

关 键 词：同型半胱氨酸 循环酶法 全自动生化分析仪 方法学评价 

分 类 号：R446.6[医药卫生—诊断学]