不同免疫分析系统测定血清心肌标志物的比对分析和偏倚评估

Comparative analysis and bias assessment of serum cardiac markers between different immunoassay systems

目的:探讨贝克曼DXI800化学发光免疫分析仪和梅里埃VIDAS荧光酶标免疫分析仪对肌钙蛋白I(TNI)、肌红蛋白(MYO)测定结果的可比性,为检验结果互认和临床实验室认可提供依据。方法:以贝克曼DXI800免疫分析仪为参考方法(X),梅里埃VIDAS免疫分析仪为试验方法(Y),用不同浓度的患者新鲜血清分别进行TNI、MYO的检测,计算两个分析系统测定结果的相关系数(r)及直线回归方程,计算TNI、MYO在医学决定水平处的预期误差。结果:两台仪器测定的TNI、MYO结果的相关系数均>0.975,偏倚均在临床允许误差范围内。结论:当使用两种以上检测系统检测同一项目时,应定期进行方法比对和偏倚评估,确保测定结果的可比性。本实验室的两台免疫分析仪测定TNI、MYO的结果具有较好的可比性。

Objective：To investigate the comparability between Beckman DXI800 immunoassay system and Bi- omerieux VIDAS inmmnoassay analyzer in determining troponin I （TNI） and myoglobin （MYO）, and provide basis for mutual recognition of determination results and clinical laboratory accreditation. Methods ： Beckman DXI800 im- mune system as the reference method （ X）, the bioMerieux VIDAS immune analyzer as test method （ Y）, the fresh serum from patients with different coneentrations was collected for detection of TNI and MYO. The correlation coeffi- cient （r） and the linear regression equation of TNI and MYO tested by the two analysis system were calculated for their expected error at medical decisions. Results ： The correlation coefficients of TNI and MYO measured by the two instruments were 〉 0. 975, and bias were both in clinical permissible range. Conclusion： When using two or more detection systems to analyze the same project, method comparison and bias estimation can ensure the comparability of measurement results. The two immunoassay analyzers in this paper have good comparability to detect the concen- trations of TNI and MYO.