应用EP10-A初步评价XI-921型电解质分析仪

Preliminary evaluation of the electrolyte analyzer XI-921 using the EP10-A protocol

目的应用EP10-A初步评价XI-921型电解质分析仪的多方面性能。方法依照《定量临床检验方法的初步评价:批准指南(EP10-A)》,使用欣越华XI-921型电解质分析仪测定血清钾。按要求每天对高、中、低定值样本进行测定,计算偏差、总不精密度,及其截距、斜率、非线性、互染率、漂移性,并进行t检验。结果偏差:高值0.036mmol/L、中值0.058mmol/L、低值0.047mmol/L。总不精密度:高值0.65%、中值0.37%、低值0.50%。截距:0.083mmol/L(P<0.01)。线性:0.992(P<0.01)。互染率:-0.036mmol/L(P>0.01)。非线性:-0.019(P>0.01)。漂移性:0.001(P>0.01)。结论使用该仪器测定血清钾,偏差、总不精密度均在允许范围内。在一定的范围内有良好的线性关系,互染率较低,稳定性很好,各项指标均能满足临床要求。

Objective To preliminarily evaluate the electrolyte analyzer XI-921. Methods Using the NLSI Document EP10-A, Preliminary Evaluation of Quantitative Clinical Laboratory Methods（ Approved Guideline） , to preliminarily evaluate the electrolyte analyzer XI-921. The bias, total imprecision, intercept, slope, nonlinearity, carryover and drift were calculated. Results While the quantitative control serum concentrations of potassium were 5.70 mmol/L, 4.65 mmol/L, 3.60 mmol/L respectively, the bias was 0. 036 mmol/L, 0. 058 mmol/L, 0.047 mmol/L, the total imprecision CV% was 0.65% , 0.37%, 0.50%, respectively , and the intercept was 0. 083 mmol/L （ P 〈 0.01 ）, the slope was 0. 992 （ P 〉 0. 01 ）, the nonlinearity was - 0. 019 （ P 〉 0. 01 ）, the carryover was - 0. 036 mmol/L （ P 〉 0.01 ） , the drift was 0. 001 （ P 〉 0.01 ）. Conclusion Using XI-921 to determine the serum concentration of potassium, the bias and the total imprecision are both within the acceptable range. The intercept, the slope, the nonlinearity, the carryover and the drift are all in the allowed range. The parameters of the instrument can satisfy clinical demands.