同科室两种生化检测系统对10项生化项目测定结果的比对和偏倚分析

目的:通过本科室两种生化检测系统(BDS)对10项常规生化项目的检验结果进行比对分析和偏倚评估,探讨不同BDS对同一检测项目的结果是否具有可比性和偏倚可接受性。方法:根据美国临床实验室标准协会EP9-A2文件标准要求,每天随机选取8例新鲜血清样本在贝克曼AU2700为参比系统]和XC8001为试验系统]全自动生化分析仪上测定10项(谷丙转氨酶、谷草转氨酶、白蛋白、总蛋白、肌酐、尿素、总胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇)常规生化项目,每例样本按正反序重复检测两次,连续测量5天,记录各测定值。计算Y与X之间的相关系数,直线回归方程和不同医学决定水平处的相对偏差。并以美国临床实验室改进修正案能力验证规则(CLIA,88)分析质量要求中规定可接受范围的1/2作为标准,判断两BDS之间的可比性和偏倚临床可接受性。结果:未发现有离群点出现,10个常规生化检测项目的r值均≥0.975,满足EP9-A2文件规定r≥0.975(或R2≥0.95)的要求。所检测数据经单因素方差分析,差异无统计学意义(P>0.05)。10个常规生化检测项目不同Xc的相对偏差SE%,结果均<可接受范围的1/2。结论:本院两种BDS通过方法学比对,对同一检测项目测定结果具有一致性,且各检测项目在各医学决定水平处出现偏倚临床是接受可接受性。

Comparison and bias analysis of 10 biochemical test results of two biochemical test systems in the same department

objective:The results of 10 routine biochemical items were compared and evaluated by two biochemical testing systems(BDS),To explore the comparability and bias acceptability of the results of the same test items by different BDS.Methods:According to the Clinical and Laboratory Standards Institute(CLSI)EP9-A2 document standard requirements,10 routine biochemical items(alanine aminotransferase,alanine aminotransferase,albumin,total protein,creatinine,urea,total cholesterol,triglyceride,high-density lipoprotein cholesterol and low-density lipoprotein cholesterol)were randomly selected from eight fresh serum samples per day on a Beckman AU2700as a reference system]and XC8001as a test system],Each sample was tested twice in positive and negative order,measured continuously for 5 days,and each measured value was recorded.Calculate the correlation coefficient between Y and X,the linear regression equation and the relative deviation at different medical decision levels.and the comparability and bias clinical acceptability between the two bds were judged by using 1/2 of the acceptable range in the us clinical laboratory improvement amendment capability validation rule(clia,88)analysis quality requirements.Results:no outliers were found,and the r values of 10 routine biochemical detection items were all≥0.975,meeting the requirements of r≥0.975(or R2≥0.95)as specified in the EP9-A2 document.The measured data were analyzed by single factor ANOVA,and the difference was not statistically significant(P>0.05).the relative deviation SE%of different xc in 10 routine biochemical test items,the results were all<1/2 of the acceptable range.Conclusion:By means of methodological comparison,the two kinds of BDS are consistent with the results of the same test item,and the clinical acceptability of the bias of each test item at each level of medical decision.