Giannopoulos A, Manousakas T, Gounari A, Constantinides C, Choremi-Papadopoulou H, Dimopoulos C
Departments of Urology and Immunology, University of Athens Medical School, Laikon Hospital and G. Papanicolaou Research Center, Saint Savas Hospital, Athens, Greece.
J Urol. 2001 Aug;166(2):470-5.
We compared overall sensitivity and specificity of the urinary bladder cancer antigen enzyme-linked immunosorbent assay (UBC, IDL Biotech, Sollentuna, Sweden), BTA stat test (Bion Diagnostic Sciences, Inc., Redmond, Washington) and NMP22 test kit (Matritech, Newton, Massachusetts), and the differential sensitivity regarding the histological pattern of tumors.
A total of 213 patients with clinical and/or imaging signs of bladder cancer provided a single voided urine sample for the bladder cancer antigen, BTA stat test and NMP22 before cystoscopy. Of these patients 95 were monitored for superficial bladder cancer, while the remaining 118 had no history of bladder cancer. All detected bladder tumors or suspicious lesions were resected transurethrally. A group of 21 age and sex matched healthy volunteers were also evaluated with the same tests.
Bladder cancer was confirmed histologically in 118 patients, of whom primary and recurrent tumors were in 68 and 50, respectively. The optimal cutoffs calculated with receiver operating characteristics curves were 8 units per ml. for NMP22 and 12 microg./l. for bladder cancer antigen. Overall sensitivity and specificity were 72.9% and 64.6% for the BTA stat test, 63.5% and 75.0% for NMP22, and 80.5% and 80.2%, respectively, for bladder cancer antigen. Bladder cancer antigen proved significantly more sensitive than NMP22 for detecting bladder cancer (p = 0.001) but not more than the BTA stat test, while the specificity of it was significantly higher than that of the BTA stat test (p = 0.009). Bladder cancer antigen had a sensitivity of 80.7% for stage Ta tumors, which was significantly higher than NMP22 (52.6%, p = 0.001) and the BTA stat test (57.9%, p = 0.01). In grade I tumors the sensitivity of bladder cancer antigen (70%) did not differ significantly than that of the BTA stat test (50%) and NMP22 (50%, p = 0.14). Bladder cancer antigen had the least false-positive results in patients with a history of bladder cancer and negative cystoscopy, and those with urological disease other than bladder cancer.
Our data indicate that bladder cancer antigen may be a more potent diagnostic marker for bladder cancer than NMP22 and the BTA stat test based on the higher sensitivity for detecting low stage and low grade tumors, and the higher specificity. The contribution of these tests for detection of bladder cancer should still be considered adjunctive to cystoscopy.
我们比较了膀胱癌抗原酶联免疫吸附测定（UBC，IDL生物技术公司，瑞典索伦特纳）、BTA stat检测（Bion诊断科学公司，华盛顿州雷德蒙德）和NMP22检测试剂盒（Matritech公司，马萨诸塞州牛顿）的总体敏感性和特异性，以及它们在肿瘤组织学类型方面的差异敏感性。
共有213例有膀胱癌临床和/或影像学征象的患者在膀胱镜检查前提供了一份晨尿样本用于膀胱癌抗原、BTA stat检测和NMP22检测。其中95例患者接受浅表性膀胱癌监测，其余118例无膀胱癌病史。所有检测到的膀胱肿瘤或可疑病变均经尿道切除。另外还对21名年龄和性别匹配的健康志愿者进行了相同检测。
118例患者经组织学确诊为膀胱癌，其中原发性肿瘤和复发性肿瘤分别为68例和50例。通过受试者工作特征曲线计算出的最佳临界值，NMP22为每毫升8单位，膀胱癌抗原为每升12微克。BTA stat检测的总体敏感性和特异性分别为72.9%和64.6%，NMP22为63.5%和75.0%，膀胱癌抗原分别为80.5%和80.2%。在检测膀胱癌方面，膀胱癌抗原被证明比NMP22更敏感（p = 0.001），但不比BTA stat检测更敏感，而其特异性显著高于BTA stat检测（p = 0.009）。膀胱癌抗原对Ta期肿瘤的敏感性为80.7%，显著高于NMP22（52.6%，p = 0.001）和BTA stat检测（57.9%，p = 0.01）。在I级肿瘤中，膀胱癌抗原的敏感性（70%）与BTA stat检测（50%）和NMP22（50%，p = 0.14）相比无显著差异。在有膀胱癌病史且膀胱镜检查阴性的患者以及患有除膀胱癌以外的泌尿系统疾病的患者中，膀胱癌抗原的假阳性结果最少。
我们的数据表明，基于对低分期和低级别肿瘤更高的敏感性以及更高的特异性，膀胱癌抗原可能是比NMP22和BTA stat检测更有效的膀胱癌诊断标志物。这些检测在膀胱癌检测中的作用仍应被视为膀胱镜检查的辅助手段。
