荧光免疫法和2种化学发光法检测血清总β-HCG结果的比对分析

The Comparison and analysis of serum totalβ-HCG detected by fluorescence immunoassay and two chemiluminescence methods

目的:通过比较同一实验室3种不同方法学(荧光免疫法(星童Pylon3D)、电化学发光法(罗氏e601)和酶促化学发光法(迈瑞CL-6000i))测定血清总β-HCG的结果,探讨3种方法检测β-HCG的结果是否具有可比性,为不同仪器测定实验结果互认提供依据。方法:选取不同浓度常规血清标本186份,先在罗氏e601电化学发光系统进行检测,再用星童Pylon3D荧光免疫法和迈瑞CL-6000i酶促化学发光法检测系统进行检测。以罗氏e601电化学发光检测系统作为参考仪器进行数据比对。结果:3种方法学之间检测结果的相关性都在0.99以上,相关性良好。随着β-HCG浓度范围的增高,3种方法学检测结果的相关性,都呈现出越来越高的趋势。总体一致性分析,迈瑞的数值与罗氏较为靠近,偏倚均数Bias=-528.3mIU/mL,P<0.05,是最低的,另外两组的偏倚均数都在-1000mIU/mL以上。结论:3种检测系统对总β-HCG检测结果之间具有良好的相关性和一致性。

Objective:To compare the results of serum totalβ-HCG measured by fluorescence immunoassay(Pylon 3D)electrochemiluminescence assay(Roche E601)and enzymatic chemiluminescence assay(Mindray CL-60001)in the same laboratory,and to explore whether these three methods are comparable in the detection ofβ-HCG.It provides a basis for mutual recognition of experimental results measured by different methodology.Methods:A total of 186 routine serum samples with different concentrations of β-HCG were assayed by Roche E601 electrochemiluminescence system,then by Pylon 3D fluorescent immunoassay,and Mindray CL-6000I enzymatic chemiluminescence detection system.Roche E601 electrochemiluminescence detection system was first used as the reference instrument for data comparison.Then,results from Mindray CL-6000I and Pylon 3D were analyzed for comparability.Results:The correlation among three methods was above 0.99,which was good.With the increase of β-HCG concentration,the correlation among three methods became stronger.The overall consistency analysis showed that Mindray's value was close to Roche's,with the lowest Bias mean=-528.3 mIU/mL.Meanwhile the Bias mean of the other two groups were all above negative 1000 mIU/mL.Conclusion:There is a good correlation and consistency between the three detection systems for totalβ-HCG.