罗氏全自动电化学发光免疫分析仪检测白细胞介素-6的方法学评价  

Methodological evaluation of Roche automatic electrochemiluminescence immunoanalyzer for detection of interleukin-6

作　　者：卫丽[1] 刁晓艳 梁涯 Wei Li;Diao Xiaoyan;Liang Ya(Department of Medical Laboratory,Qinghai Provincial People's Hospital,Xining 810007,Qinghai,China;Clinical Laboratory,Tongdewei Branch of Guangzhou Hospital of Traditional Chinese Medicine,Guangzhou 510006,Guangdong,China)

机构地区：[1]青海省人民医院医学检验科,青海西宁810007 [2]广州市中医医院同德围分院检验科,广东广州510006

出　　处：《实用检验医师杂志》2022年第1期71-73,共3页Chinese Journal of Clinical Pathologist

摘　　要：目的评价罗氏Cobas E602全自动电化学发光免疫分析仪模块定量检测白细胞介素-6(IL-6)的分析性能。方法对罗氏全自动电化学发光免疫分析仪定量检测IL-6的准确度、精密度和线性进行验证,并进行交叉污染率评估实验。结果经不同批次校准品检测,测定值与靶值的相对偏差为-3.01%~3.84%。批内变异系数(CV)为1.84%~2.80%,批间CV为0.67%~1.43%,检测的准确度和精密度均符合性能标准。IL-6检测回归分析呈一次线性,线性回归方程为y=1.0081x-1.0009(R^(2)=0.99996,P<0.05)。IL-6检测的交叉污染率为0.077%。结论罗氏Cobas E602全自动电化学发光免疫分析仪对IL-6检测性能的验证结果与仪器生产厂家提供的说明基本一致,符合临床实验室检验的要求,可用于临床标本测定。Objective To evaluate the analytical performance of Roche Cobas E602 automatic electrochemiluminescence immunoanalyzer module for quantitative detection of interleukin-6(IL-6).Methods The accuracy,precision and linearity of IL-6 quantitative detection by Roche automatic electrochemiluminescence immunoanalyzer were verified and the cross contamination rate test was performed.Results The relative deviation between measured value and target value was-3.01%to 3.84%.The coefficient of variation(CV)of intra batch was 1.84%-2.80%,and the CV of inter batch was 0.67%-1.43%.The accuracy and precision met the performance standard.The regression analysis of IL-6 detection showed linearity,and the linear equation was y=1.0081x-1.0009(R2=0.99996,P<0.05).The results of cross contamination rate test showed that the cross contamination rate of IL-6 detection was 0.077%.Conclusions The main detection performance of Roche Cobas E602 automatic electrochemiluminescence immunoanalyzer for IL-6 is basically consistent with the manufacturer's statement,meets the quality target requirements,and can be applied to the detection of clinical samples.

关 键 词：白细胞介素-6 电化学发光 方法学评价 

分 类 号：R446.6[医药卫生—诊断学]