酶循环法测定血清同型半胱氨酸的方法学评价  

Evaluation of enzymatic cycling assay for determining homocysteine

作　　者：陈渡波[1] 何秋莹[1] 杜倩怡[2] 冯品宁[1] 姚真荣[1] 陈少谦 林文彬[1] 徐鸿绪[1] 

机构地区：[1]中山大学附属第一医院检验医学部,广东广州510080 [2]广东省妇幼保健院医学遗传中心,广东广州511442

出　　处：《热带医学杂志》2016年第4期437-439,455,共4页Journal of Tropical Medicine

摘　　要：目的对酶循环法(ECA)定量测定血清同型半胱氨酸(Hcy)的试剂盒进行方法学评价。方法参考CSLI发布的方法学评价系列文件,对该方法学的精密度、分析灵敏度、功能灵敏度、线性范围、抗干扰能力和准确性进行评价,并与ABBOTT i2000化学发光微粒子免疫检测法(CMIA)的测定结果进行统计学分析,同时对厂商声明的生物参考区间进行验证。结果 ECA定量测定血清Hcy的批内变异系数(CV)和总CV分别为1.39%~2.53%和2.15%~4.82%;分析灵敏度和功能灵敏度分别为0.06和2.08μmol/L;6.20~50.50μmol/L范围内测定的线性相关系数(R^2)达0.998 4;低、高浓度定值质控血清测定的相对偏差分别为-2.85%和2.24%;57例临床标本AU5800(ECA法)测定结果与i2000(CMIA法)测定结果相关性良好(R^2=0.994 4),血红蛋白(3.75 g/dl)、胆红素F(37.5 mg/dl)和乳糜(7 000浊度)对该测定方法无明显干扰;40名健康体检者Hcy测定结果均处于厂家推荐的参考区间内。结论酶循环法测定Hcy的主要分析性能达到了厂商声明的性能和有关质量要求,可作为一种准确可靠、快捷价廉的临床常规检测方法。Objective To evaluate the enzymatic cycling assay（ECA） for determining homocysteine（Hcy）. Methods The precision, analysis sensitivity, functional sensitivity, linear range, interference and accuracy of this method were evaluated according to EP documents issued by CLSI and related references. The ECA results were statistically compared with the results from ABBOTT i2000（CMIA）, and verified by the biological reference range provided by the manufacturer. Results The within-run CV and total CV were 1.39% ~2.53% and 2.15% ~4.82%, respectively. The analysis sensitivity and functional sensitivity were 0.06 and 2.08 μmol/L, respectively. The linear correlation coefficient（R^2） was 0.998 4 in 6.20~50.50 μmol/L,both of the relative deviations of the low-level serum（-2.85%） and high-level serum（2.24%）. There was a good correlation between ECA with CMIA from 57 specimens（R^2=0.994 4）. There was no obvious interference from hemolysis（3.75 g/dl）,jaundice（37.5 mg/dl） and lipid turbidity（7 000 U）. All the results of 40 healthy subject samples were included in the reference interval recommended by the manufacturer. Conclusion ECA for the determination of homocysteine is comparable with the ABBOTT i2000（CMIA） within the standard range provided by the manufacturer, it is a rapid, inexpensive, accurate and reliable.

关 键 词：酶循环法 同型半胱氨酸 方法学评价 

分 类 号：R446.11[医药卫生—诊断学]