电化学发光法测定红细胞叶酸水平的性能评价

目的 评价电化学发光法测定红细胞叶酸浓度的方法.方法 通过重复性试验、回收试验、干扰试验、线性试验和方法学比对对本方法进行评价,并建立本方法的参考范围;在此基础上对30例补充叶酸60天以上的孕妇的红细胞叶酸水平进行测定.结果 本方法的批内和批间的变异系数（CV）分别为2.57％和3.55％,回收率为98.0％,线性范围为40.2 ～ 1174.82ng/mL,甘油三酯（148mg/dL）和胆红素（0.6mg/dL）不会对本实验造成影响.本实验室红细胞叶酸值的参考范围是111.33～603.75ng/mL.本法测得的红细胞叶酸结果与放射免疫法结果比较相关性良好（r=0.998）,两种方法测定结果差异无显著性.30例补充叶酸60天以上的孕妇的红细胞叶酸水平为911.23±198.19ng/mL,与对照组（423.57±135.78 ng/mL）相比差异有统计学意义（P＜0.01）.结论 电化学发光法能够准确、快速的测定红细胞叶酸浓度,且该法重复性好,适合应用于临床检测.

Determination of Red Cell Folate Concentrations with Electrochemiluminescence Method

Objective To evaluate the chemiluminescence （ECL） method for the determination of red cell folate concentration.Methods Evaluation of the methods includes repeated test,recovery test,interference test,linear test,methodology comparison and establishment of the reference range.Then,the red cell folate levels of 30 pregnant women who intake folic acid for more than 60 days were measured.Results The intra and inter CV of the method were 2.57% and 3.55%,respectively.The recovery of this assay was 98.0%.The assay was linear from 40.2-1174.82ng/mL,and it wouldn＇t be interference by triglyceride （148mg/dL） or bilirubin （0.6mg/dL）.The reference range of red cell folate was 111.33-603.75ng/mL.The results determined with ECL method and RIA had no significant difference.The results were also positively correlated （r =0.998）.The red cell folate levels in 30 pregnant women who intake folic acid for more than 60 days had significant differences compared with the results of control group.Conclusion ECL can be an accurately and rapid method for determination of red cell folate concentrations,and this method is suitable for clinical application.