参考测量程序对血清钠、钾常规检测系统的正确度评价

Accuracy evaluation of routine measurement procedures for serum sodium and potassium ion based on reference measurement procedure

目的以参考测量程序(离子色谱法)为比对方法,评价电极法和酶法测定血清钠、钾离子的正确度。方法采用离子色谱法测定2014年的RELA样本,26份单份新鲜血清样本中的钠、钾离子,同时采用电极法和酶法在全自动生化分析仪上检测血清中的钠、钾离子,测定结果依据EP09-A3和EP14-A3文件进行方法学比对评价。结果钠项目电极法和酶法与离子色谱法比对的直线方程分别为y=1.015x+0.435、y=0.987x+4.355,平均偏移分别为1.85%和1.90%;钾项目电极法和酶法与离子色谱法比对的直线方程分别为y=1.019x+0.038、y=0.947x+0.483,平均偏移分别为2.56%和4.35%。依据EP09-A3文件,钠、钾项目电极法与离子色谱法的正确度一致,酶法与离子色谱法的正确度不一致。结论离子色谱法能准确测定血清样本中的钠、钾浓度。为保证临床样本测量结果的准确性,离子色谱法可作为正确度评价方法用于评价钠、钾常规检测系统的正确度。

Objective To evaluate the tureness of ion selective electrode method and enzymic method for serum sodium and potassium based on ion chromatography. Methods The RELA samples in 2014 and 26 fresh serum samples were conducted for the detection of sodium and potassium ions by ion chromatography method,ion selective electrode method and enzymatic method,and the detection results were compared according to EP09-A3 and EP14-A3. Results The measured results for potassium with ion selective electrode method and enzymatic method showed that the regression equation was y = 1. 015 x ＋ 0. 435 and y = 0. 987 x ＋ 4. 355,respectively,and the average bias was 1. 85% and 1. 90%,respectively. The measured results for potassium with ion selective electrode method and enzymatic method showed that the regression equation was y = 1. 019 x ＋ 0. 038 and y = 0. 947 x ＋ 0. 483,respectively,and the average bias was 2. 56% and 4. 35%,respectively. According to EP09-A3,the accuracy of electrode method and ion chromatography was consistent,but that of enzymic method and ion chromatography was not consistent. Conclusion Ion chromatography method can accurately determine the concentrations of sodium,potassium in serum samples. In order to ensure the accuracy of measurement results,ion chromatography can be used as a correct evaluation method for the accuracy evaluation of sodium,potassium conventional detection system.