ELISA定量分析尿液BLCA-1/-4水平诊断膀胱癌的临床价值分析

目的:探讨膀胱癌患者尿液膀胱特异性核基质蛋白(bladder cancer specific nuclear matrix proteins,BLCA)-1/-4水平及其临床应用价值。方法:本研究纳入38例膀胱癌患者、40例正常对照组。采集受试者尿液样本,通过竞争性酶联免疫吸附法(enzymelinked immunosorbent assay,ELISA)定量分析尿液中BLCA-1和BLCA-4的水平,绘制受试者工作曲线,确定cut-off值。结果:膀胱癌患者尿液BLCA-1/-4水平均显著高于对照组(P0.001);当cut-off值取0.859 ng/mL时,BLCA-1诊断膀胱癌的敏感性和特异性分别为71%(27/38)、90%(36/40)。肌层浸润性膀胱癌患者尿液BLCA-1较非肌层浸润性膀胱癌患者水平显著升高(P0.001),但不同分级膀胱癌患者尿液BLCA-4水平无显著差异(P0.05)。高级别膀胱癌患者尿液BLCA-4水平较低级别膀胱癌患者显著升高(P0.05),但不同分期膀胱癌患者尿液BLCA-4水平无显著差异(P0.05)。以cut-off为0.859 ng/mL时,BLCA-1诊断膀胱癌的敏感性和特异性分别为71%(27/38)、90%(36/40)。以cut-off为0.620 ng/mL时,BLCA-4诊断膀胱癌的敏感性和特异性分别为76.3%(29/38)、97.5%(39/40)。联合检测尿液BLCA-1和BLCA-4诊断膀胱癌的敏感性和特异性分别为84.2%(32/38)和100%(40/40),准确度为0.923(77/78),阳性预测值为100%(32/32),阴性预测值为86.9%(40/46)以及YOUDEN指数分别为0.842。结论:膀胱癌患者尿液BLCA-1和BLCA-4水平显著升高,且敏感性和特异性均较高。联合检测尿液BLCA-1和BLCA-4较单一检测用于诊断膀胱癌的临床应用价值更高。

Clinical Value of Urine BLCA-1/-4 Levels Detected by ELISA for the Diagnosis of Bladder Cancer

ABSTRACT Objective: To determine the urine levels of bladder cancer specific antigen-1/-4 (BLCA-1/-4) in the patients with bladder cancer and its clinical value. Methods: 38 cases of bladder cancer, and 40 healthy control cases were selected as the research subject. Urine samples were collected from all patients. A competitive enzyme-linked immunosorbent assay was used to determine the BLCA-1 and BLCA-4 levels in urine. The cut-off value is determined by ROC curve. Results: Urine BLCA-1 and BLCA-4 levels in BC patients were significantly higher than those in the healthy controls (P<0.001); ROC curve showed that the sensitivity and specificity of BLCA-1 in the urine for the diagnosis of bladder cancer were 71% (27/38) and 90% (36/40) with a cut-off value of 0.859 ng/mL. BLCA-1 levels in the urine of MIBC (T2-T4) were significantly higher than those patients without muscular coat invasion (Ta-T1, P<0.001), but there was no significant difference in the level of BLCA-4 in patients with different grades of bladder cancer (P>0.05). The level of BLCA-4 was higher in the high grade of bladder cancer (P<0.05), but there was no significant difference in the level of BLCA-4 in patients with different stages of bladder cancer (P>0.05). ROC curve showed that the sensitivity and specificity of the urinary BLCA-1 for the diagnosis of bladder cancer were 71% (27/38) and 90% (36/40) with a cut-off value of 0.859 ng/mL, and the sensitivity and specificity of the urinary BLCA-1 for the diagnosis of bladder cancer were 76.3% (29/38) and 97.5% (39/40) with a cut-off value of 0.620 ng/mL. The sensitivity and specificity of combined detection of BLCA-1 and BLCA-4 in the diagnosis of bladder cancer were 84.2% (32/38) and 100%(40/40), respectively, with accuracy of 0.923(77/78), positive predictive value of 100%(32/32), negative predictive value of 86.9%(40/46) and YOUDEN index of 0.842. Conclusion: The levels of BLCA-1 and BLCA-4 in urine of patients with bladder cancer were significantly increased, and it showed a high level of sensitivity and specificity in diagnosing the bladder cancer. Combined detection of urine BLCA-1 and BLCA-4 in diagnosing bladder cancer showed more valuable than single marker.