循环酶法检测同型半胱氨酸的性能验证分析  

Performance verification of cycling enzymatic method in homocysteine detection

作　　者：符俊超[1] 邸玉玮[1] 郑卫东[1] 戴耀宗[1] 董晖[1] 

机构地区：[1]广东省人民医院广东省医学科学院检验科,广东广州510080

出　　处：《中国卫生检验杂志》2014年第13期1913-1915,1918,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的验证循环酶法检测同型半胱氨酸各项性能。方法检测质控血清验证不精密度;低值血清验证功能灵敏度,按EP6-A方法验证线性范围,回收实验验证最大可稀释倍数与抗干扰能力;与参考方法比较验证准确度;检测健康人血清验证正常参考范围。结果批内检测CV为1.46%、3.54%,批间检测CV为1.68%、5.03%;分析测量范围2.16μmol/L^478.35μmol/L;维生素C 10 mg/dl、胆红素342μmol/L、血红蛋白12 g/L、甘油三酯39.12 mmol/L水平,实测值与理论值偏倚均<5%;与高效液相色谱法比较,10例样本偏倚均<10%;20例健康人血清检测均在参考范围内。结论循环酶法检测同型半胱氨酸各项性能符合临床实验室要求。Objective To test the performance of cycling enzymatic method in detection of homocysteine.Methods Quality control serum was detected to verify the imprecision of cycling enzymatic method.Low-value serum was detected to verify the function sensitivity of the method.The linear range of the method was verified according to EP6-A method.Recovery experiments were used to test the maximum dilution and anti-interference ability.The accuracy of the method was verified by comparison with the reference method.Serum of healthy people was detected to verify the normal reference range.Results The within-run CVs of repeated serum measurements were 1.46% and 3.54%,while those of the between-run CVs were 1.68%and 5.03%.The analytic measurement range of the method was 2.16 μmol/L ~ 478.35 μmol/L.When the vitamin C level was at 10 mg/dl,bilirubin level at 342 μmol/L,hemoglobin level at 12 g/L and triglyceride level at 39.12 mmol/L,the bias of the actual value and theoretical value were all less than 5%.Compared with HPLC,the bias of 10 samples was less than 10%.Detection results of 20 samples were all in the medical reference rage（≤20 μmol/L）.Conclusion The performance parameters of cycling enzymatic method were all available for laboratory detection requirements of homocysteine.

关 键 词：同型半胱氨酸 酶法 分析测量范围 准确度 

分 类 号：R446.11[医药卫生—诊断学]