血站血液检测设备性能对比方法的探讨  

A discussion on the performance comparison method of blood testing equipment in blood station

作　　者：范文成[1] 王棚[1] 冯霞[1] 刘旭明艳 何小艳[1] 陈素琼[1] FAN Wencheng;WANG Peng;FENG Xia(Red Cross Center Blood Station of Mianyang City,Mianyang 621000,China)

机构地区：[1]绵阳市红十字中心血站,四川绵阳621000

出　　处：《中国医学装备》2018年第9期36-40,共5页China Medical Equipment

摘　　要：目的:探讨血站血液检测设备性能对比方法。方法:选取献血者血液标本50份,室内质控标本22份,2015年室间质评标本16份,使用2台不同型号的FAME全自动酶免后处理系统和2台全自动生化分析仪,分别进行对比试验。使用同样全自动加样仪进行加样,对2台FAME全自动酶免后处理系统进行平行检测,对比其一致性。对2台全自动生化分析仪的低值、高值质控标本的比对偏差进行分析,同时用2台设备平行检测24份血液标本,分析2台设备的一致性、比对偏差以及检测结果的一致性。结果:(1)2台FAME室内质控检测均值接近,变异系数小;(2)16份室间质量评价检测结果与50份常规献血者标本检测结果一致;(3)2台全自动生化分析仪低值和高值质控标本的比对偏差分别为2.4%和1.74%,均低于分析质量要求(6%);(4)24份献血者标本在2台全自动生化分析仪上的检测结果经回归分析,一致性为优。结论:选择适宜的标本对血站全自动酶免后处理系统与全自动生化分析仪检测性能进行对比,其方法稳定、操作简便易行,可作为血站血液检测设备性能对比方法。Objective:To discuss performance comparison method for blood testing equipment of blood station.Methods:The blood samples of 50 blood donors,22 internal quality control and 16 specimens of external quality assessment in 2015 year were selected in this research.And two different model FAME full-automatic ELISA postprocessing systems and two full-automatic biochemical analyzers were compared,respectively.The same full-automatic sampler was used to add sample,and 2 FAME full-automatic ELISA post-processing systems were used to implement parallel detection,and the consistency between them was contrasted.And the comparison deviations of low and high quality control specimen of the two automatically biochemical analyzers were analyzed.At the same time,the two equipments were used to implement parallel detection for 24 blood samples.The consistency of comparison deviation and detection result between the two equipments were further analyzed.Results:The detection means of internal quality control of two FAME equipments were similar and the variable coefficient was small.The 16 detection results of external quality assessment and the detection results of 50 routine blood donors were consistency.And the comparison deviations of low quality control specimen and high quality control specimen of two full-automatically biochemical analyzers were 2.4%and 1.74%,respectively,and all of them were lower than requirement of analysis quality(6%).And the consistency of 24 samples between two full-automatic biochemical analyzers were excellent through regression analysis for their detection results.Conclusion:The method that selected the appropriate specimen to compare the performance of detection of full-automatic ELISA post-processing system and full-automatic biochemical analyzer of blood station is stability and its operation is simple and feasibility.Therefore,it can be used as comparison method of performance of blood testing equipment in blood station.

关 键 词：血站 血液检测设备 检测性能 对比 自动酶免后处理系统 自动生化分析仪 

分 类 号：R197.39[医药卫生—卫生事业管理]