14台POCT血气分析仪与中心实验室检测结果的一致性分析

Comparison of 14 point-of-care blood gas analyzers testing results with central laboratory

目的分析14台床旁检测(POCT)血气分析仪和中心实验室血气分析仪检测结果的一致性。方法采用中心实验室血气分析仪及14台POCT血气分析仪分别检测3个浓度水平质控品,每天检测2次,连续检测4 d,共24次,根据检测结果计算pH、动脉血二氧化碳分压(PCO_(2))、动脉血氧分压(PO_(2))、K^(+)、Na^(+)、Cl^(-)、Ca^(2+)的均值、标准差和变异系数等;计算14台POCT血气分析仪检测结果与中心实验室检测结果的偏倚及偏倚率;应用ANOVA检验、Passing-Bablok回归分析对14台POCT血气分析仪与中心实验室检测结果一致性进行分析评价。结果14台POCT血气分析仪各比对项目检测结果的变异系数均小于生产商声明的性能范围。14台POCT血气分析各比对项目的检测结果与中心实验室的偏倚均小于国家卫生健康委员会临床检验中心室间质量评价标准。14台POCT台血气分析各比对项目的检测结果比较,差异均无统计学意义(P>0.05)。14台POCT血气分析仪检测结果与中心实验室pH值、PCO_(2)、PO_(2)、K^(+)、Na^(+)、Cl^(-)、Ca^(2+)检测结果模拟回归方程的截距和斜率均在95%置信区间,且P>0.05,与中心实验室检测结果具有高度的一致性。结论14台POCT血气分析仪具有良好的精密度,且14台POCT血气分析仪之间及与中心实验室间均具有较好的一致性。

Objective To analyze the consistency of the results of 14 point-of-care testing(POCT)blood gas analyzers and blood gas analyzers in central laboratory.Methods The central laboratory blood gas analyzer and 14 POCT blood gas analyzer were used to detect three concentration levels of control materials,twice a day for 4 consecutive days,a total of 24 times.According to the test results,the mean value,standard deviation and coefficient of variation of pH,arterial partial pressure of carbon dioxide(PCO_(2)),arterial partial pressure of oxygen(PO_(2)),K^(+),Na^(+),Cl^(-),Ca^(2+)were calculated.The bias and bias rate between the results of 14 POCT blood gas analyzers and the results of central laboratory were calculated.ANOVA test and Passing-Bablok regression analysis were used to analyze and evaluate the consistency of the results between the 14 POCT blood gas analyzer and the central laboratory.Results The coefficients of variation of 14 POCT blood gas analyzers were less than the performance range declared by the manufacturer.The bias between the test results and the central laboratory was less than the external quality assessment standard of National Center for Clinical Laboratories.There was no significant difference between the results of blood gas analysis of 14 POCT units and the results of blood gas analysis of central laboratory(P>0.05).The intercept and slope of the test results including pH,PCO_(2),PO_(2),K^(+),Na^(+),Cl^(-),Ca^(2+)of 14 POCT blood gas analyzers and the simulated regression equation of the central laboratory were all in the 95%confidence interval,P>0.05,which was highly consistent with the test results of the central laboratory.Conclusion The 14 POCT blood gas analyzers have good precision,and the consistency between the 14 POCT blood gas analyzers and the central laboratory is good.