多台POCT血气分析仪比对方法的建立与分析

Establishment and analysis of comparison methods among POCT blood gas analyzers

目的根据临床实验室标准化协会对仪器比对的要求和即时检验(POCT)血气分析仪的特点,建立基于质控数据的仪器比对方法。并采用建立的比对方法比较华西医院各临床科室和中心实验室23台血气分析仪检测结果的一致性。方法参照临床实验室标准化协会对仪器比对的要求,收集每台POCT血气分析仪连续30 d的室内质控结果,计算均值、标准差(s)和变异系数(CV)。要求每台POCT血气分析仪的CV<1/3允许总误差(TEa),并根据每台POCT血气分析仪的均值,计算均值的均值、s和CV;基于同型号血气分析仪分析同批号质控品的均值应一致的理论,以均值间的CV<1/2 TEa判断各血气分析仪检测结果一致。结果23台血气分析仪30 d pH值、二氧化碳分压[P(CO2)]和氧分压[P(O2)]3个水平质控结果的CV均<1/3 TEa(pH值TEa为0.54%,P(CO2)TEa为8.00%,P(O2)TEa为12.00%)。23台POCT血气分析仪pH值3个质控水平均值的CV分别为0.07、0.08、0.02,均<1/2 TEa;P(CO2)3个质控水平均值的CV分别为0.63、1.78、1.48,均<1/2 TEa;P(O2)3个质控水平均值的CV分别为2.88、1.90、0.95,均<1/2 TEa。结论华西医院23台POCT血气分析仪分析结果一致,建立的比对方法可满足实验室认可和三级甲等医院评审要求。

Objective According to the requirement of comparison of the Clinical and Laboratory Standards Institute and the characteristics of point-of-care testing(POCT)blood gas analysis,to establish a comparison method based on quality control data,and to compare the consistency of 23 blood gas analyzers in the clinical departments and central laboratory of West China Hospital of Sichuan University.Methods With the reference to the requirement of the Clinical and Laboratory Standards Institute,all quality control results of 23 blood gas analyzers in 30 d were collected.The mean,standard deviation(s)and coefficient of variation(CV)were calculated,and CV must be less than 1/3 allowable total error(TEa).The mean of means and its s and CV were calculated.Based on the same mean should be got from the same system and quality control of the same lot,when the CV of means less than 1/2 TEa,the results should be consistent.Results CV of 3 levels of pH,partial pressure of carbon dioxide[P(CO2)]and partial pressure of oxygen[P(O2)]were less than 1/3 TEa[pH TEa 0.54%,P(CO2)TEa 8.00%and P(O2)TEa 12.00%],and CV of 3 levels of pH mean for 23 analyzers were 0.07,0.08 and 0.02,respectively,which were all less than 1/2 TEa.CV of 3 levels of P(CO2)mean for 23 analyzers were 0.63,1.78 and 1.48,which were all less than 1/2 TEa.CV of 3 levels of P(O2)mean for 23 analyzers were 2.88,1.90 and 0.95,which were all less than 1/2 TEa.Conclusions The results of 23 blood gas analyzers in west China Hospital are consistent,which meet the requirement of larboratory accreditation and the third class A hospital accreditation.