人血清CYFRA21-1化学发光免疫分析方法的初步建立及应用

The Preliminary Establishment and Application of Chemiluminescence Immunoassay for Detection of Human CYFRA21-1 in Serum

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-Na_2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。

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 beth 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 ）. Compa- ring to ECLA, the clinical aceordance 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.