微流控技术与传统化学发光技术检测NT-proBNP、心肌标志物的时间比较及结果偏倚分析

Time comparison and bias analysis on results of NT-proBNP and cardiac markers detected by microfluidics and conventional chemiluminescence

目的分析西门子Dimension EXL全自动生化分析仪与微点全自动微流控荧光免疫分析仪i300在临床应用中的优势。方法根据CLSI-EP9-A2文件规定,将西门子Dimension EXL全自动生化分析仪作为参比检测系统,将微点全自动微流控荧光免疫分析仪i300作为实验检测系统,对45份患者血清的NT-proBNP、心肌标志物(CKMB和cTnI)进行检测,比较两种检测方法的检测时间,并将测试结果进行数据处理,进行偏倚评估。结果西门子Dimension EXL全自动生化分析仪在检测NT-proBNP及心肌标志物所用的时间为微点全自动微流控荧光免疫分析仪i300检测两个项目所用时间的3倍左右,差异均有统计学意义(P<0.001)。将两个检测系统检测三个指标结果的散点图进行线性回归统计,回归方程分别为Y=1.04X-11.73、Y=0.9912X+0.1362、Y=1.0006X+0.0044,决定系数R^2分别为0.987、0.9981、0.9999,均>0.95,回归分析结果有效。偏倚分析显示两种检测方法之间存在临床可接受范围内的偏倚。结论微点全自动微流控荧光免疫分析仪i300与西门子Dimension EXL全自动生化分析仪的检测结果偏倚在临床可接受范围内,结果具有一致性,且微点i300检测的时间较快,更适合于急诊科室使用。

Objective By comparing the detection time and consistency between SIEMENS Dimension EXL automatic biochemical analyzer and microdot full automatic microfluidic immunofluorescence analyzer i300 for the detection of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac markers (CKMB,cTnI),to determine the favorable detection system in clinical application.Methods According to the CLSI-EP9-A2 document,SIEMENS Dimension EXL automatic biochemical analyzer was set as reference detection system,while microdot full automatic microfluidic immunofluorescence analyzer i300 was set as test detection system,respectively.Serum levels of NT-proBNP and cardiac markers in 45 patients were measured,and the time of two detection systems were compared.Bias estimations were assessed by comparing the processed results between two detection systems.Results The average detection time of the two objects by SIEMENS Dimension EXL automatic biochemical analyzer was almost three times longer than the microdot full automatic microfluidic immunofluorescence analyzer i300.The difference was statistically significant between the two detection systems ( P <0.01).Linear regression of scatter plot of the two detection systems revealed that the regression equation were Y=1.04X-11.73,Y=0.9912X+0.1362,Y=1.0006X+0.0044 and the determination coefficient (R 2) were 0.987,0.9981,0.9999,which were more than 0.95 and indicated the validity of the regression analysis result.In addition,bias evaluation on results of the two systems indicated clinically acceptable range of biases.Conclusion The detection results of the microdot full automatic microfluidic immunofluorescence analyzer i300 and SIEMENS Dimension EXL automatic biochemical analyzer are biased within the clinically acceptable range and remain consistent.In addition,the detection time of microdot i300 is shorter and more suitable for the emergency setting.