Mian C, Pycha A, Wiener H, Haitel A, Lodde M, Marberger M
Department of Urology, University of Vienna, Austria.
J Urol. 1999 May;161(5):1486-9. doi: 10.1016/s0022-5347(05)68934-3.
The limitations of cytology and the invasiveness of cystoscopy for detecting bladder cancer generate increasing interest in noninvasive, urine bound diagnostic tools. We assessed the diagnostic value of the newly developed immunocytochemical test, Immunocyt, which detects cellular markers specific for transitional cell cancer in the voided urine of patients with bladder cancer.
Participating in our prospective study were 264 consecutive patients with a mean age of 65.9 years, including 114 in whom symptoms were suggestive of bladder cancer and 150 who were being followed after complete transurethral resection of superficial transitional cell carcinoma. Voided urine specimens were evaluated by standard cytology and the Immunocyt test, which traces the monoclonal antibodies M344, LDQ10 and 19A211 against transitional cell carcinoma in exfoliated urothelial cells. In all cases cystoscopy was subsequently performed and any suspicious lesion was evaluated by biopsy.
Histologically proved transitional cell carcinoma was found in 79 patients. Immunocyt with cytology had 89.9% sensitivity overall (84, 88 and 96.5% in grades 1 to 3 disease, respectively). A total of 34 (43%), 3 (3.8%) and 34 (43%) cases were positive on Immunocyt only, cytology only and both evaluations, respectively. In 8 cases (10.1%) both tests were negative. Overall Immunocyt only was 86.1% sensitive (84, 84 and 89.6% in grades 1 to 3 disease, respectively) and 79.4% specific. Overall cytology only was 46.8% sensitive (4, 52 and 79.3% in grades 1 to 3 disease, respectively) and 98.2% specific.
Immunocyt is a noninvasive, highly sensitive test for detecting transitional cell carcinoma of all grades and stages. When combined with conventional urinary cytology, it may replace cystoscopy in select patients, especially in followup protocols of low grade transitional cell carcinoma.
细胞学检查的局限性以及膀胱镜检查在检测膀胱癌时的侵入性，使得人们对非侵入性的尿液诊断工具越来越感兴趣。我们评估了新开发的免疫细胞化学检测方法Immunocyt的诊断价值，该方法可检测膀胱癌患者晨尿中特异性针对移行细胞癌的细胞标志物。
264例连续患者参与了我们的前瞻性研究，平均年龄65.9岁，其中114例有膀胱癌相关症状，150例在浅表性移行细胞癌经尿道完全切除术后接受随访。对晨尿标本进行标准细胞学检查和Immunocyt检测，该检测追踪针对脱落尿路上皮细胞中移行细胞癌的单克隆抗体M344、LDQ10和19A211。所有病例随后均进行膀胱镜检查，对任何可疑病变进行活检。
79例患者经组织学证实为移行细胞癌。Immunocyt联合细胞学检查总体敏感性为89.9%（1至3级疾病分别为84%、88%和96.5%）。仅Immunocyt阳性、仅细胞学阳性及两者均阳性的病例分别有34例（43%）、3例（3.8%）和34例（43%）。8例（10.1%）两种检测均为阴性。总体而言，仅Immunocyt的敏感性为86.1%（1至3级疾病分别为84%、84%和89.6%），特异性为79.4%。仅细胞学检查总体敏感性为46.8%（1至3级疾病分别为4%、52%和79.3%），特异性为98.2%。
Immunocyt是一种用于检测各级别和各阶段移行细胞癌的非侵入性、高敏感性检测方法。与传统尿液细胞学检查联合使用时，它可能在部分患者中替代膀胱镜检查，尤其是在低级别移行细胞癌的随访方案中。
