摘要
目的对"迈瑞"多个型号的全自动生化分析仪进行偏倚评估,为遴选优秀国产生化设备提供实验依据。方法参照CLSI EP9-A2文件,以"贝克曼"AU5400为参比检测系统,"迈瑞"4个型号(BS200、BS380、BS480和BS820)为实验检测系统,对15项常规生化项目进行比对分析。通过比较两个检测系统的决定系数R^2、线性回归方程斜率和医学决定水平处的偏差进行偏倚评估。结果实验检测系统和参比检测系统的相关性良好。两个检测系统间存在一定的系统偏差,但以我国卫生行业标准为质量目标,只有血清总蛋白、白蛋白和钙3个项目与参比检测系统不具可比性(即TP、ALB、CA的质量目标分别是5%、6%、5%,BS200、BS380、BS480和BS820中TP的平均偏倚分别为8.74%、4.59%、5.85%、8.26%,ALB的平均偏倚分别为12.66%、14.07%、11.66%、12.99%,CA的平均偏倚分别为6.79%、7.85%、7.7%、8.96%,3个项目在4台仪器均出现1个或多个医学决定水平的偏倚大于质量目标),其余12个项目具有可比性。结论 "迈瑞"与"贝克曼"检测系统的偏倚在临床可接受范围内,可在基层医院推广使用。
Objective To determine the biases among different series of Mindray auto-biochemical analyzers and subsequently provide experimental bases for selecting optimal domestic auto-biochemical analyzers. Methods According to Clinical and Laboratory Standards Institute（ CLSI） guideline（ EP9-A2）,Beckmann Coulter AU5400 was set as reference detection system,while Mindray auto-biochemical analyzers BS200,BS380,BS480 and BS820 were set as test detection systems,respectively. Fifteen conventional biochemical tests were selected for method comparison. Bias estimations were assessed by comparing determination coefficient（ R^2）,slope of regression equation,bias of medical decision level between the reference detection system and single test detection system,respectively. Results Fairly good correlations were seen between the reference detection system and the single test detection system,respectively. There were certain systematic biases between the reference and test systems. Only serum levels of total protein（ TP）,albumin（ ALB） and calcium（ Ca） were out of comparability,while the rest of the 15 tests were within comparability when China＇s health industry standards were set as quality goals. The quality goals of TP,ALB and CA were 5%,6% and 5%,respectively. The average bias of TP detected by BS200,BS380,BS480 and BS820 were 8. 74%,4. 59%,5. 85% and 8. 26%,respectively. While those of ALB were 12. 66%,14. 07%,11. 66% and 12. 99%,respectively,and those of CA were 6. 79%,7. 85%,7. 7% and 8. 96%,respectively.The average biases of TP,ALB and CA were greater in these 4 analyzer than quality goals at one or more medical decision levels. Conclusion The comparability between the detection system of Mindray series and the reference system of Beckmann Coulter AU 5400 is acceptable. Auto-biochemical analyzers of Mindray series deserve promotion for further use in basic level units.
出处
《第三军医大学学报》
CAS
CSCD
北大核心
2016年第9期997-1002,共6页
Journal of Third Military Medical University
基金
国家科技支撑计划项目(2013BAI17B04)~~
关键词
检测系统
生化分析仪
偏倚评估
detection system
bio-chemistry analyzer
bias Evaluation
