【摘要】 目的:建立人血清CYFRA21-1化学发光免疫分析方法并在临床检测中的应用。方法:使用CY-FRA21-1定量测定试剂盒（化学发光法）检测308例临床血清标本,并与CYFRA21-1电化学发光全自动免疫分析方法进行对比。结果:灵敏度0.04μg/L,线性范围（1.5～100）μg/L,与NSE及CEA无交叉反应,样本中抗凝剂量的柠檬酸钠、肝素、EDTA-Na₂对测定结果没有影响。添加回收率和稀释回收率为90%～110%,分析内和分析间变异系数均<10.0%。该方法正常参考值为（0～3.4）μg/L（95%可信限）。ECLA测定结果与本法相比,临床总符合率为96.65%。结论:该方法灵敏度高、特异性好、稳定性强,检测范围宽,有良好的准确性和重复性,完全可替代进口化学发光试剂用于临床样本的检测。更多还原

【Abstract】 Objective To estimate an enhanced chemiluminescence immunoassay for detection CYFRA21-1 in serum.Methods CYFRA21-1 chemiluminescence quantitative immunoassay kit was used.308 clinical samples were detected,compared with ECLA CY-FRA21 -1 immunoassay.Results The sensitivity of the assay was 0.04μg/L.The linear range was(1.5～100)μg/L,and there was no significant cross-reaction with NSE or CEA.The recovery rate of addition and dilution were both below 10%.Besides,the intra- and intercoefficients of variations were from 90%to 110%.The 0.95 confidence interval for normal samples was 0～3.4μg/L(n =231).Comparing to ECLA,the clinical accordance rate was 96.65%.Conclusion The sensitivity,specificity,stability and detection range of this method are all good enough to meet the clinical requirement,furthermore,to take the place of the foreign like products.更多还原