电化学发光技术检测尿中角蛋白19片段的意义

Detection of CK19 in bladder cancer by using electrochemiluminescence immunoassay

目的 检测膀胱癌患者尿液中细胞角蛋白 19片段 (cytokeratin 19fragment,CK19,Cyfra2 1 1)的水平 ,探讨CK19片段与膀胱癌的关系。方法 应用电化学发光免疫分析技术 (ECLIA) ,对 45份膀胱癌患者尿液中CK19片段含量进行测定 ,并与正常对照组和泌尿系良性疾病组及其他肿瘤组进行对照分析。结果 膀胱癌组尿CK19平均值为 ( 12 2 0 0± 12 6 0 ) μg/L ,明显高于正常对照组( 1 97± 0 88) μg/L和泌尿道良性疾病组 [尿路感染组 ( 6 70± 2 42 ) μg/L、肾炎组 ( 3 40± 1 41) μg/L、前列腺炎组 ( 1 6 8± 0 5 4) μg/L]及其他肿瘤组 ( 4 10± 1 80 ) μg/L ,差异具显著性意义 ( P <0 0 1)。以3 9ng/ml为临界值 ,尿CK19对膀胱癌的敏感性为 93 3% ,特异性为 82 7% ,阴性预测值高达 97 7%。结论 尿液中CK19片段含量可作为膀胱癌的辅助诊断指标 ,因其具有灵敏、快速、无痛性的优点 ,适用于膀胱癌的筛查和术后复发的监控。

Objective We study the potential diagnostic use of urinary cytokeretin 19 fragment (CK19,Cyfra21-1). Methods Urinary CK19 was investigated by using an electrochemiluminescence immunoassay(ECLIA) in urin of 47 healthy subjects and 154 patients including 45 with bladder cancer,94 with urological benign diseases and 15 nonbladder cancers. Result The urinary CK19 average level of patients suffered from bladder cancer is (122。00±12。60) μg/L that is significantly different from the level of healthy control[(1。97±0。88) μg/L, P<0。01], urinary tract infection [(6。70±2。42) μg/L,P<0。01], nephritis [(3。40±1。40) μg/L, P<0。01] and other cancers [(4。10±1。80) μg/L, P<0。01]. The cutoff that was obtained by the 99% percentile in healthy subjects is≤ 3。9 μg/L. With the cutoff the overall sensitivity was 93。3%, specificities was 82。7%, false-positive rate is 18.6% in all. Conclusion Urinary CK19 level is an useful parameter for selecting high risk patients with bladder cancer for a more oriented cystoscopy.