目的探讨两种血清Her-2/neu蛋白检测试剂检测结果的一致性，为合理选择检测试剂提供依据。方法应用西门子公司化学发光法(chemiluminescenceimmunoassay，CLIA)和DRG公司ELISA法两种试剂对乳腺癌组195份、健康对照组60份和其他肿瘤患者组100份样本进行Her-2/neu蛋白检测，比较两种试剂检测结果的一致性。结果355份样本中有351份测定结果一致，总符合率为98.87%(351/355);两组检测结果的相关系数r值为0.9919，P=0.000。健康对照组和其他肿瘤组患者的Her-2/neu蛋白检测值均低于临界值。结论两种血清Her-2/neu蛋白检测试剂可比性强，化学发光法试剂是一种良好的检测方法，能够满足临床需求。
Objective To investigate the comparability of the two kinds of serum Her-2/neu protein detection reagent and provide experimental data for choosing reasonable detection method and reagent. Methods Serum samples from 195 cases of breast cancer group, 60 cases of healthy control group and 100 cases of other tumor patients group were detected by Simens chemiluminescence immunoassay (CLIA) and DRG ELISA methods respectively. Results The detection results of 351samples in all 355 samples were consistent with two reagents and the total coincidence rate was 98.87%. The correlation coefficient r was 0.9919 between the two groups of detection results (P=0.000). All the Her-2/neu protein results in patients other tumor and healthy controls were lower than that of cutoff value. Conclusion The two kinds of serum Her-2/neu protein detection reagent are comparable, and the CLIA might be a good selection for clinical practice.
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