【摘要】 目的建立一种定量测定游离β人绒毛膜促性腺激素(freeβhuman chorionic gonadotrophin,f-β-h CG)的化学发光免疫分析法,并对其性能进行评价。方法利用双抗体夹心法,对反应步骤进行筛选,建立游离β人绒毛膜促性腺激素定量测定的化学发光免疫分析法,并对其最低检测限、准确度、重复性、批间精密度、特异性、参考范围及样本比对进行评价。结果经过筛选,选用了二步法反应步骤;对f-β-h CG试剂盒进行方法学评价,最低检测限可达0.006 ng/m L,准确性相对偏差在2.56%～4.43%,线性在0～200 ng/m L,相关系数R~2=1,重复性CV值均小于8%,批间CV值均小于15%;与罗氏的游离β-绒毛膜促性腺激素定量测定试剂盒(电化学发光法)测定结果显著相关,一致性达0.965,线性回归方程为y=1.131x+0.826,相关性r值为0.992,2种试剂盒的检测结果具有较高的一致性。结论本研究自制试剂盒的各项性能均能符合临床检验的要求,有望能替代昂贵的进口试剂应用于临床检测及研究。更多还原

【Abstract】 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.更多还原