人附睾蛋白4检测试剂方法学评价

Methodological evaluation of electrochemistry luminescent technique for HE4 detection

摘要: 目的通过对罗氏公司电化学发光法检测人附睾蛋白4(human epididymal protein 4，HE4)试剂的方法学评价。方法检测本方法的批内变异系数和批间变异系数、线性实验。比较本方法与酶联免疫法检测结果的相关性分析，评估此方法的可靠性。结果在检测范围内，该方法的线性良好，检测的批内变异系数分别为1.05%和1.83%，批间变异系数分别为2.63%和2.68%，与酶联免疫法试剂检测结果比较呈良好相关性(R²=0.996 6)。结论本方法测定结果准确可靠，操作简便，值得推广使用。

Abstract: Objective To evaluate the detection methodology of HE4 using electrochemistry luminescent technique (Roche Company). Methods The variation coefficients for within runs and between runs and linear experiment were detected with electrochemistry luminescent technique, and compared with those detected by ELASA. The reliability of electrochemistry luminescent technique was assessed. Results The electrochemistry luminescent technique had a good linearity in the detection range. The variation coefficient for within runs and between runs was 1.05 and 1.83, and 2.63% and 2.68%, respectively, which were well correlated with those detected by ELISA (R²=0.9966). Conclusion The electrochemistry luminescent technique is accurate， reliable, and easy to operate, and is thus worthy to be widely used in clinical practice．