BUN、Cr、GLU、UA在三种生化分析系统间的对比分析和偏倚评估
Comparative analysis and bias evaluation of the testing results of BUN,Cr,GLU and UA among three different biochemical analysis systems
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摘要: 目的: 探讨尿素氮(BUN)、肌酐(Cr)、血糖(GLU)、尿酸(UA)在本地区三家大型医疗机构的三种生化分析系统之间检测结果是否具有可比性,并进行偏倚评估,以验证这几项检验结果是否可在三家医院间互认。方法: 依据美国临床实验室标准化委员会(NCCLS) EP9-A2文件方案,每天选取临床样本5~7份,分别在三所医院的三种生化分析系统(BeckmanCX4、Olympus2700、日立7600)进行测定,共测定7天41个样本,记录检验结果,去除1个离群值后,共40个样本结果,以BeckmanCX4生化分析仪为比较方法,另两台作为实验方法,对检测结果进行对比分析和偏倚评估。结果: BUN、Cr、GLU、UA在三种生化分析系统间的检测结果相关性较好(r2均>0.95),线性回归方程良好,除Cr正常参考范围内结果的预期偏倚在允许偏倚之外,其它预期偏倚均在允许偏倚内。结论: 在做好室内质量控制和室间质量评价的基础上,BUN、Cr、GLU、UA在三所医院的三种生化分析系统间的检验结果可以互认,实现检验结果一单通。Abstract: Objective: To explore and evaluate the comparability and bias of the testing results of blood urea nitrogen (BUN), creatinine (Cr), glucose (GLU) and uric acid (UA) derived from three different biochemical analysis systems in three hospitals and to validate whether mutual accredit of these testing results can be performed among these hospitals. Methods: According to the document of NCCLS EP9-A, 5-7 clinic samples were detected in three kinds of different biochemical analysis systems (Beckman CX4, Olympus 2700 and Hitachi 7600) respectively everyday. The testing results of total 41 samples were recorded within 7 days and those of 40 samples were kept after one outlier value was deleted. The testing results derived from three biochemical analysis systems were analyzed comparatively and their bias was evaluated by biochemical analysis in Beckman CX4 as a control method and biochemical analyses in Olympus 2700 and Hitachi 7600 as experimental methods. Results: Both correlation (r2>0.95) and linear regression between the testing results of BUN, Cr, GLU and UA in three different biochemical analysis systems in three hospitals were good. Their anticipated biases (but with exception for Cr when its testing result was within the normal reference range) were within allowed biases. Conclusions: On the basis of good internal quality control and external quality assessment, the testing results of BUN, Cr, GLU and UA derived from three different biochemical analysis systems from the three hospitals can be mutually accredited.