电解质分析仪钾斜率定标及补正与标准液选择的研究

The research on electrolyte analyzer potassium slope calibration,calibration corrections and the choice of standard fluid

目的研究在电解质分析仪钾斜率定标及定标补正时,选择不同标准液对测定结果的影响,通过对定值质控血清测定的准确性分析,确定定标与定标补正最佳实验浓度。方法使用日本常光EX-Z电解质分析仪和深圳越华科技公司MI921电解质分析仪,分别进行钾标准液定标和定标补正。EX-Z使用仪器配套A4.0 mmol/L、B6.0 mmol/L两点钾标准液自动定标,MI921使用仪器配套A4.0 mmol/L、B8.0 mmol/L两点标准液自动定标。再使用RANDOX钾标准液A3.0 mmol/L、B7.0mmol/L进行定标补正。分别在定标与补正后,检测20次不同浓度的5组定值质控品,高值（H17.39 mmol/L、H26.02 mmol/L）,中值（M4.43 mmol/L）,低值（L13.53 mmol/L、L22.56 mmol/L）,取内值分析评估两台仪器两种定标模式对钾检测准确性的影响,计算检测值与定值之间的变异指数VIS,按我国卫生部质控的评价标准,进行临床可接受性能评价。结果 （2）自动定标组,EX-Z组定值质控品检测mmol/L均值是：H17.01、H25.79、M 4.41、L13.67、L22.87、,L2为x±2s规则失控结果,临床可接受性为H1和L2不接受、H2和L1合格接受;MI921组对定值质控品检测mmol/L均值是：H17.12、H25.89、M 4.46、L13.66、L22.85,L2为x±2s规则失控结果,临床可接受性为L2不接受、L1和H1合格接受。两组M值临床可接受性均为优秀接受。（2）定标补正组,EX-Z组和MI921组的定值质控品检测均没有出现x±2s规则失控结果,临床可接受性只有MI921组L2合格接受,其余优秀接受。结论电解质分析仪钾定标标准液最佳浓度是A点2.8~3.2mmol/L、B点7.0~7.5 mmol/L,若仪器原配钾标准液A点大于或等于4.0 mmol/L或B点小于或等于6.0mmol/L时,应选择最佳标准液范围内的标准液进行钾斜率回归式Y=aX＋b有效补正,使钾测定区间有效地覆盖临床可能出现的高低值,保证结果的准确性。

Objective To investigate the influence of choosing different standard fluid on the test results of the electrolyte analyzer potassium slope calibration and calibration corrections,,and to determine the optimal experimental concentration of calibration and calibration corrections through the accurate analysis of the measurement of setting value quality-control serum.Methods We used Japanese EX-Z electrolyte analyzer and MI921 electrolyte analyzer made by shenzhen YueHua scientifie and technology company to analyze the potassium standard fluid calibration and calibration amendments.EX-Z used two kinds of automatic calibration standard fluid which were A4.0mmol/L auxiliary instrument and B6.0mmol/L,while potassium MI921 used two standard fluid automatic calibration which were A4.0 mmol/L auxiliary instrument and B8.0 mmol/L.Then we used RANDOX potassium A3.0 and B7.0 mmol/L standard fluid for calibration amendments.After calibration and correction,five sets of high quality products with different concentrations were detected 20 times,the high value（H1 7.39 mmol/L,H2 6.02 mmol/L）,the median（M4.43 mmol/L）,the low value（L13.53 mmol/L,L2 2.56 mmol/L）.Then we analyzed and evaluated the accuracy of the inspected potassium value under two calibration models,and calculated the VIS value between the detected value and the fixed value according to the Chinese ministry of health index of quality evaluation criteria.Then the clinical acceptable performance was evaluated.Results 1.Automatic calibration group：EX-Z group setting value mmol/L quality-control product testing mean were as followed：H1 7.01,H2 5.79,M4.41,L1 3.67,L2 2.87.L2 for x±2s rules out of control results.Clinically,H1 and L2 were not accepted while H2 and L1 were accepted,The tested mean mmol/L value of the quality-control substance of the MI921 group were as followed：H1 7.12,H2 5.89,M4.46,L1 3.66,L2 2.85.L2 for x±2s rules out of control results.Clinically L2 was not accepted,while L1 and H1 were accpted.The clinical acceptability of M value of the two groups were well accepted.2,scaling corrections group：The x±2s rules out of control results did not appear in the detection of the fixed quality substance in EX-Z group and MI921 group,The clinical acceptability of L2 of MI921 group was basically accepted,the others were well accepted.Conclusion The optimal concentration of electrolyte analyzer potassium calibration standard fluid is as followed： point A 2.8—3.2 mmol/L,point B 7.0—7.5 mmol/L.If original point A of potassium standard fluid of the instrument was≥4.0 mmol/L or point B≤6.0 mmol/L,we should choose the best standard fluid with the standard fluid scope to carry out potassium slope regression Y=aX＋b effective supplement,in order to make the potassium determination interval effectively covers the possible clinical highest as well as lowest value,therefore guarantees the accuracy of the results.