Vriesema J L, Atsma F, Kiemeney L A, Peelen W P, Witjes J A, Schalken J A
Department of Urology, University Medical Centre Nijmegen, Nijmegen, The Netherlands.
Urology. 2001 Sep;58(3):367-71. doi: 10.1016/s0090-4295(01)01217-1.
To study the diagnostic performance of the ImmunoCyt test in patients in follow-up for superficial urothelial cell carcinoma (UCC) of the bladder.
Voided urine samples were collected from all included patients. Samples were processed with the ImmunoCyt test. The ImmunoCyt slides were scored under a fluorescence microscope by 3 observers. The ImmunoCyt test was considered positive if one or more observers scored the test positive. Urethrocystoscopy (and additional histologic examination in the case of suspicious cystoscopic findings) was used as the reference standard. To investigate the validity of ImmunoCyt, sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve, and diagnostic odds ratios were determined. To investigate the reproducibility of ImmunoCyt, kappa values (measure of agreement) were computed. The observers' findings were analyzed in pairs.
One hundred four patients in follow-up after primary superficial UCC of the bladder were included. Samples of 18 patients had to be excluded because of low cellularity (ie, insufficient assessable urothelial cells). Tumor recurrence was found in 22 of the remaining 86 patients (17 pTa, 3 pT1, 1 carcinoma in situ, 1 pT2 or higher). The test had a sensitivity of 50%, specificity of 73%, positive predictive value of 39%, and negative predictive value of 81%. The diagnostic odds ratio was 2.8 (95% confidence interval 1.0 to 7.5). The area under the curve for the different observers varied between 0.54 and 0.60. The kappa values were low (0.05 to 0.45), representing high interobserver variability.
The promising results from other studies could not be confirmed in this specific group of patients in follow-up for superficial UCC of the bladder. The validity of ImmunoCyt was insufficient to justify the omission of cystoscopy in patients in follow-up for superficial UCC.
研究免疫细胞检测对膀胱浅表性尿路上皮癌（UCC）患者随访的诊断效能。
收集所有纳入患者的晨尿样本。样本采用免疫细胞检测法进行处理。免疫细胞检测玻片由3名观察者在荧光显微镜下评分。若一名或多名观察者将检测评为阳性，则免疫细胞检测被视为阳性。尿道膀胱镜检查（以及在膀胱镜检查结果可疑时进行额外的组织学检查）用作参考标准。为研究免疫细胞检测的有效性，确定了敏感性、特异性、阳性预测值、阴性预测值、受试者操作特征曲线下面积和诊断比值比。为研究免疫细胞检测的可重复性，计算了kappa值（一致性度量）。对观察者的结果进行成对分析。
纳入了104例膀胱原发性浅表性UCC术后随访的患者。由于细胞数量少（即可评估的尿路上皮细胞不足），18例患者的样本不得不被排除。在其余86例患者中，有22例发现肿瘤复发（17例pTa，3例pT1，1例原位癌，1例pT2或更高分期）。该检测的敏感性为50%，特异性为73%，阳性预测值为39%，阴性预测值为81%。诊断比值比为2.8（95%置信区间1.0至7.5）。不同观察者的曲线下面积在0.54至0.60之间。kappa值较低（0.05至0.45），表明观察者间变异性较高。
在这组膀胱浅表性UCC随访患者中，无法证实其他研究中令人满意的结果。免疫细胞检测的有效性不足以证明在膀胱浅表性UCC随访患者中省略膀胱镜检查是合理的。
