摘要
目的:通过对同一临床实验室不同血气分析系统进行方法对比和测定结果偏倚评估,研究不同血气分析系统测定结果是否具有可比性或测定结果的偏差是否在允许范围内。方法:按照EP9-A文件的要求,以Roche OMNI C血气分析仪为对比方法,GEM premier 3000血气分析仪为试验方法,用患者动脉血标本对pH、PCO2、PO2三个血气分析项目进行检测,对两分析系统测定结果进行统计,求得直线回归方程、相关系数及标准误,在给定的医学决定水平下,计算允许误差(EA)、预期偏差(SE)以及预期偏差95%的可信限,以美国临床实验室修正法规(CLIA’88)规定的室间质量评价允许误差范围为标准,对本研究两台不同血气分析系统测定结果进行方法对比和偏倚评估。结果:在检测的3个项目中,除PO2的预期偏差不能被接受外,其余两项预期偏差均可被接受。结论:当实验室内同一检测项目存在两套及两套以上分析时,应对其进行方法对比和偏差评估,判断其临床可接受性,以保证检测结果的可比性。
Objectives This trial was performed to evaluate the comparability of the test outcomes or the acceptability of the outcome bias of different blood gas analysis systems under the same laboratory conditions. Methods According to the profile NCCLS-EP9-A, the two different blood gas analysis systems, Roche OMNI C （comparison method） and GEM premier 3000 （laboratory method） were used respectively to test artery blood items such as pH, PCO2 , and PO2 to obtain the correlation coefficient and the linear equation. Under the given test level, we calculated EA, SE and its 95 % confidence limit. According to the profile CLIA＇88, then the coefficient and the equation were used to evaluate the outcome bias between these two systems. Results Among these 3 tests, except of PO2 , the outcome biases of pH and PCO2 were acceptable. Conclusions In order to insure the accuracy and the comparison of the test outcome, the method comparison and bias evaluation should be employed when using different blood gas analysis system under the same laboratory conditions.
出处
《四川省卫生管理干部学院学报》
2006年第3期166-168,共3页
Journal of Sichuan Continuing Education College of Medical Sciences
关键词
血气分析
方法对比
偏差评估
Blood gas analysis Method comparison Bias estimation.
