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《Journal of Molecular Diagnostics and Therapy》 2018-05
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Quantitative determination of free β human chorionic gonadotropin:establishment and performance evaluation of chemiluminescence immunoassay

WU Huaying;WANG Xiaoyan;LI Zhixiong;DONG Zhining;WU Yingsong;XU Weiwen;School of Laboratory Medicine and Biotechnology,Southern Medical University;Zhaoqing Medical College;Darui Biotechnology Co.,Ltd.,Guangzhou;  
Objective To establish a chemiluminescence immunoassay for quantitative determination of free β human chorionic gonadotrophin(f-β-h CG)and evaluate its performance.Methods The double antibody sandwich method was used to screen the reaction steps,and the chemiluminescence immunoassay method for quantitative determination of free β human chorionic gonadotropin was established.The minimum detection limit,accuracy,repeatability,inter-assay precision and specificity were determined.The reference range and sample comparison were evaluated.Results After screening,the two-step reaction step was selected.The methodological evaluation of f-β-h CG kit was carried out.The minimum detection limit was0.006 ng/m L,the relative deviation of accuracy was 2.56%-4.43%,the linearity was 0-200 ng/m L,the correlation coefficient R~2=1,the repetitive CV values are less than 8%,and the inter-assay CV values are less than15%.Compared to the Roche.s free β-chorionic gonadotropin quantification kit(electrochemiluminescence method),the results were significantly correlated,the consistency was 0.965,the linear regression equation was y=1.131 x+0.826,and the correlation r value was 0.992.The detection results of the 2 kits were highly consistent.Conclusion The performance of the home-made kits in this study can meet the requirements of clinical testing,and it is expected to replace expensive imported reagents for clinical testing and research.
【Fund】: 广东省重大科技专项项目(2012A080203012)
【CateGory Index】: R446.6
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