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北京京煤集团总医院                                                          第十一届·2023 学术年会论文集


                     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


                               崔雯,姜慧英,王鹏飞,李丽艳(北京京煤集团总医院检验科)
                   【摘要】目的:通过比较同一实验室 3 种不同方法学检测系统荧光免疫法(星童 Pylon 3D)、


                   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 Pylon 3D 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 种发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 种发方法学检测结果

                   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=-528.3 mIU/mL,是最低的,另外两组的偏倚均数都在负 1000 mIU/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。

                   【关键词】人绒毛膜促性腺激素,不同方法学,相关性,一致性

                    The Comparison and analysis of serum total β-HCG detected by fluorescence immunoassay

                                            and two chemiluminescence methods
                   [Abstract] Objective: To compare the results of serum total β-HCG measured by fluorescence


                   immunoassay  (Pylon  3D),  electrochemiluminescence  assay  (Roche  E601)  and  enzymatic
                   chemiluminescence assay (Mindray CL-6000I) with three different methods in the same laboratory,

                   and to explore whether the three methods are comparable in the detection of β-HCG. It provides a

                   basis for mutual recognition of experimental results measured by different instruments. Methods:

                   A total of 186 routine serum samples with different concentrations were detected by Roche E601

                   electrochemiluminescence system, and then by Pylon 3D fluorescent immunoassay and Mindray

                   CL-6000I enzymatic chemiluminescence detection system. Roche E601 electrochemiluminescence

                   detection system was used as the reference instrument for data comparison. Results: The correlation

                   between the three methods was above 0.99, and the correlation was good. With the increase of β-

                   HCG concentration range, the correlation of the three methods showed an increasing trend. The

                   overall consistency analysis showed that Mindray's value was close to Roche's, with Bias mean =-

                   528.3 mIU/mL, which was the lowest, while the Bias mean of the other two groups were all above




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