MB-3100型系列血气分析仪临床性能评估  

The evaluation of clinical performance for blood gas analyzer: MB-3100

作　　者：卞炳贤 杜坤[1] 张广慧[1] 

机构地区：[1]上海交通大学医学院附属新华医院检验科,上海200092

出　　处：《中国医学装备》2017年第9期26-29,共4页China Medical Equipment

基　　金：上海申康医院发展中心市级医院临床辅助科室能力建设项目(SHDC22014007)"新型国产血气分析仪临床性能评估"

摘　　要：目的:对MB-3100血气分析仪分析人体血液酸碱度(pH值)、二氧化碳分压(pCO_2)和氧分压(p O2)3个项目的精密度和准确度进行评价。方法:精密度评价采用伯乐公司生产的血气质控品,按照美国临床实验室标准化研究所(CLSI)的EP5文件进行,计算检测结果的平均值、标准差(SD)和变异系数(CV);准确度评价根据CLSI的EP9-A2文件使用MB-3100与Rapidlab 1265比对的方式来评估,使用配对t检验、线性回归方程对比分析两个检测系统测定结果的一致性。所有统计分析在SPSS19.0中完成。结果:MB-3100血气分析仪各项水平精密度的检测结果均在可接受范围。准确度评价中MB-3100与Rapidlab 1265检测pH、pCO_2及p O2的结果均无统计学差异(t=0.042,t=1.489,t=-1.6;P>0.05)。并且发现两个检测系统在不同医学决定水平处的系统误差均小于其对应的允许总误差。结论:MB-3100血气分析仪的精密度和准确度均在可接受范围内,可为临床提供可靠的检测报告。Objective To estimate the precision and accuracy performance of blood gasanalyzer（MB-3100） for three measuring indicators： pH, pCO2 and pO2. Methods： Theevaluation of precision was achieved by testing quality controls of BIO-RAD, and the mean,SD and CV of the results were calculated according to protocol EP5 of Clinical and LaboratoryStandards Institute（CLSI）. The evaluation of accuracy was achieved by comparing MB-3100 and Rapidlab 1265according to the EP9-A2 of CLSI, and the consistency check of the two detection systems were analyzed by usingpaired t- test and equation of linear regression. All of these results were analyzed by using SPSS19.0. Results： Theresults of the research showed that the precision performances of analyzer MB-3100 in various detection level wereacceptable. And there was no statistically significant difference for the accuracy performances between the twosystems on pH, pCO2 and pO2, respectively （t=0.042, t=1.489, t=-1.6, P〉0.05）. Moreover, both of the system errorsof the two systems at different medical decision level were less than the corresponding total error allowances （TEa）,respectively. Conclusion： Both of the precision and accuracy performances of MB-3100 blood gas analyzer areacceptable, and it can provide reliable reports for clinical practice.

关 键 词：准确度 精密度 平均值 标准差 变异系数 允许总误差 回归方程 

分 类 号：R197.39[医药卫生—卫生事业管理]