Department of Urology, Central Hospital of Bolzano, Bolzano, Italy
Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland.
J Clin Pathol. 2019 Feb;72(2):140-144. doi: 10.1136/jclinpath-2018-205393. Epub 2018 Oct 24.
Cystoscopy and urine cytology represent the gold standard for monitoring superficial bladder cancer (BC). Xpert BC Monitor is a new urinary marker based on the evaluation of five target mRNAs overexpressed in patients with bladder cancer. The aim of our study was to evaluate the diagnostic accuracy of Xpert BC Monitor in follow-up of patients with non-muscle invasive bladder cancer (NMIBC).
230 patients were included in this prospective study. Xpert BC Monitor cut-off was set to 0.5. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cytology, Xpert BC Monitor and their combination were calculated and compared with cystoscopy/histology.
52/230 patients showed a NMIBC recurrence, 45 low grade (LG) and 7 high grade (HG). Overall sensitivity was 11.5% for cytology, 46.2% for Xpert BC Monitor and 48.1% for the two tests combined. Sensitivity of cytology increased from 4.4% in LG to 57.1% in HG tumours whereas for the Xpert BC Monitor it was 40% in LG and 85.7% in HG tumours. Combined cytology and Xpert BC Monitor yielded an overall sensitivity of 42% for LG and 85.7% for HG. Overall specificity was 97.2% for cytology, 77% for Xpert BC Monitor and 75.8% for the two tests.
Sensitivity for the Xpert BC Monitor Test was significantly higher than for cytology. The test performed very well in terms of specificity but could not reach the value of cytology, while PPV and NPV performed approximately the same for both tests.
膀胱镜检查和尿液细胞学检查是监测表浅膀胱癌（BC）的金标准。Xpert BC Monitor 是一种新的尿标志物，基于对膀胱癌患者中过表达的 5 个靶 mRNA 的评估。本研究的目的是评估 Xpert BC Monitor 在非肌层浸润性膀胱癌（NMIBC）患者随访中的诊断准确性。
本前瞻性研究纳入了 230 例患者。Xpert BC Monitor 的截断值设定为 0.5。计算细胞学、Xpert BC Monitor 及其联合检测的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV），并与膀胱镜检查/组织学进行比较。
230 例患者中有 52 例出现 NMIBC 复发，其中 45 例为低级别（LG），7 例为高级别（HG）。细胞学的总体敏感性为 11.5%，Xpert BC Monitor 为 46.2%，两种方法联合检测的敏感性为 48.1%。LG 肿瘤的细胞学敏感性从 4.4%增加到 HG 肿瘤的 57.1%，而 Xpert BC Monitor 的敏感性在 LG 肿瘤中为 40%，在 HG 肿瘤中为 85.7%。联合细胞学和 Xpert BC Monitor 的总体敏感性在 LG 肿瘤中为 42%，在 HG 肿瘤中为 85.7%。细胞学的总体特异性为 97.2%，Xpert BC Monitor 为 77%，两种方法的特异性均为 75.8%。
Xpert BC Monitor 检测的敏感性明显高于细胞学。该检测在特异性方面表现非常出色，但无法达到细胞学的水平，而 PPV 和 NPV 对两种检测方法的表现大致相同。
