两种不同方法检测血清中甘氨鹅脱氧胆酸钠的对比分析

Comparative Analysis of Two Different Methods in Detecting Serum Sodium Glycine Deoxycholate

本文探讨生化法与高效液相色谱-串联质谱法(HPLC-MS/MS)检测血清中甘氨鹅脱氧胆酸钠(GCDC)结果的相关性。根据美国国家临床实验室标准委员会(NCCLS)EP9-A文件,每天取临床样本8份,分别采用自主研发的体外诊断生化试剂和HPLC-MS/MS测定血清GCDC含量,共测定5d,记录结果,去除离群点,计算线性回归方程和相关系数,进行偏倚估计,对比生化试剂测量的准确性。通过试验得出生化法和HPLC-MS/MS方法检测血清GCDC的相关方程为Y生化法=0.9642XHPLC-MS/MS-1.2266,相关系数(r)=0.9954,两种方法结果高度相关,有很好的可比性;两种血清中GCDC检测结果具有很好的可比性,由于检测原理和仪器不同,当采用不同方法时,应对其进行对比分析和偏倚评估。

This paper investigates the correlation between biochemical method and high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)in the detection of serum glycochenodeoxycholate(GCDC).According to the document EP9-A of American Committee for Clinical Laboratory Standardization(NCCLS),40 cases of serum GCDC were detected by self-developed in vitro diagnostic biochemical reagents and HPLC-MS/MS in 5 operating days and the correlation regression and bias estimation were made.The duplicates were assessed for each method within the same run.The results were recorded and the outliers were removed.The linear regression equation and correlation coefficient were calculated to estimate the bias and compare the measurement accuracy of biochemical reagents.The results of serum GCDC were highly correlated and comparable between the two methods.The results of GCDC detection in the two sera are very comparable.Due to the different detection principles and instruments,comparative analysis and bias assessment should be carried out when different methods are used.