基于CLSI EP09c方案评价血气分析仪与干式生化分析仪血浆标本检测结果的一致性

CLSI EP09c based evaluation on the consistency of detection results of plasma samples by blood gas analyzer and dry biochemical analyzer

目的 比较血气分析仪检测的钠、钾、氯和葡萄糖结果与干式生化分析仪采用血浆标本进行相同项目检测时的结果一致性。方法 收集急诊患者血气分析数据与干式生化分析仪相同项目进行配对,其中电解质374对,葡萄糖357对,计算组内相关系数。选取最佳回归模型进行拟合,计算各参数在相应医学决定水平处的偏差,Bland-Altman法计算平均偏差。使用国家卫生行业标准的允许总误差判断偏差是否具有临床意义。结果 钠、钾、氯和葡萄糖配对数据的组内相关系数分别为0.975 2、0.941 0、0.960 8和0.993 8,均为高度相关。与干式生化分析仪相比,血气分析仪测定的钾在医学决定水平的相对偏差分别为-0.67%、-3.51%、-4.21%,平均偏差为-0.10 mmol/L,83.96%的配对数据偏差小于允许总误差;钠在医学决定水平的相对偏差分别为-1.91%、0.30%、1.55%,平均偏差为1.1 mmol/L,相对偏差符合率为94.65%;氯在医学决定水平的相对偏差分别为2.24%、1.92%,平均偏差为2.1 mmol/L,相对偏差符合率为81.82%;葡萄糖在医学决定水平的相对偏差分别为4.69%、2.24%、1.68%,平均偏差为0.16 mmol/L,相对偏差符合率为84.92%。结论 血气分析仪测定的钠、钾、氯和葡萄糖与干式生化分析仪血浆标本相同项目的检测结果具有良好的一致性,可以互换使用。

Objective To compare the result consistency of sodium,potassium,chlorine and glucose by blood gas analyzer and dry biochemical analyzer using plasma samples for the same item.Methods The data were collected from blood gas analyzer and paired with the same items of dry chemistry analyzer,including 374 pairs of electrolytes and 357 pairs of glucose,and the intra-class correlation coefficients(ICC) was counted.The best regression model was selected for fitting,the deviation of each parameter at the corresponding medical decision level was calculated,and the average deviation was calculated by the Bland-Altman method.The allowable total error of the national health industry standard was used to judge whether the deviation has clinical significance.Results The interclass correlation coefficient(ICC) of the paired data of sodium,potassium,chloride,glucose,hemoglobin and hematocrit were 0.975 2,0.941 0,0.960 8,0.993 8,all of which were highly correlated.Compared with dry chemistry analyzer,the relative bias of potassium measured by blood gas analyzer at the medically determined level was-0.67%,-3.51%,-4.21%,and the average deviation was-0.10 mmol/L,and 83.96% of the paired data deviation was less than the total allowable error.The relative bias of sodium at the medical decision level was-1.91%,0.30%,1.55%,and the average deviation was 1.1 mmol/L;the relative deviation coincidence rate was 94.65%.The relative bias of chlorine at the medical decision level was 2.24% and 1.92%,the average deviation was 2.1 mmol/L,and the relative deviation coincidence rate was 81.82%.The relative bias of glucose at the medical decision level was 4.69%,2.24%,1.68%,respectively,the average deviation was 0.16 mmol/L,and the relative deviation coincidence rate was 84.92%.Conclusion The electrolyte and glucose results measured by the blood gas analyzer are in good agreement with the plasma results of the dry biochemical analyzer and can be used interchangeably.