ObjectiveTo investigate and compare the performance of urinary cytology and the Xpert BC Monitor test in the detection of bladder cancer in various clinically significant patient cohorts, including patients with carcinoma in situ (CIS), in a prospective multicentre setting, aiming to identify potential applications in clinical practice.Patients and MethodsA total of 756 patients scheduled for transurethral resection of bladder tumour (TURBT) were prospectively screened between July 2018 and December 2020 at six German University Centres. Central urinary cytology and Xpert BC Monitor tests were performed prior to TURBT. The diagnostic performance of urinary cytology and the Xpert BC Monitor was evaluated according to sensitivity (SN), specificity (SC), negative predictive value (NPV) and positive predictive value (PPV). Statistical comparison of urinary cytology and the Xpert BC Monitor was conducted using the McNemar test.ResultsOf 756 screened patients, 733 (568 male [78%]; median [interquartile range] age 72 [62–79] years) were included. Bladder cancer was present in 482 patients (65.8%) with 258 (53.5%) high‐grade tumours. Overall SN, SC, NPV and PPV were 39%, 93%, 44% and 92% for urinary cytology, and 75%, 69%, 59% and 82% for the Xpert BC Monitor. In patients with CIS (concomitant or solitary), SN, SC, NPV and PPV were 59%, 93%, 87% and 50% for urinary cytology, and 90%, 69%, 95% and 50% for the Xpert BC Monitor. The Xpert BC Monitor missed four tumours (NPV = 98%) in patients with solitary CIS, while potentially avoiding 63.3% of TURBTs in inconclusive or negative cystoscopy and a negative Xpert result.ConclusionPositive urinary cytology may indicate bladder cancer and should be taken seriously. The Xpert BC Monitor may represent a useful diagnostic tool for correctly identifying patients with solitary CIS and unsuspicious or inconclusive cystoscopy.

中文翻译：

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改善膀胱癌原位癌的检测：尿细胞学与 Xpert® BC 监测仪

目的研究并比较尿细胞学检查和 Xpert BC Monitor 测试在各种具有临床意义的患者队列（包括癌症患者）中检测膀胱癌的性能就地(CIS)，在前瞻性多中心环境中，旨在确定临床实践中的潜在应用。患者和方法2018 年 7 月至 2020 年 12 月期间，在六个德国大学中心对总共 756 名计划接受经尿道膀胱肿瘤切除术 (TURBT) 的患者进行了前瞻性筛查。在 TURBT 之前进行中央尿细胞学检查和 Xpert BC Monitor 测试。根据敏感性（SN）、特异性（SC）、阴性预测值（NPV）和阳性预测值（PPV）评估尿细胞学和Xpert BC监测仪的诊断性能。使用 McNemar 检验对尿细胞学和 Xpert BC 监测仪进行统计比较。结果 756 名筛查患者中，733 名（568 名男性 [78%]；中位[四分位距]年龄 72 [62–79] 岁）被纳入。 482 名患者 (65.8%) 患有膀胱癌，其中 258 名患者 (53.5%) 为高级别肿瘤。尿细胞学检查的总体 SN、SC、NPV 和 PPV 分别为 39%、93%、44% 和 92%，Xpert BC 监测仪的总体 SN、SC、NPV 和 PPV 分别为 75%、69%、59% 和 82%。在 CIS（合并或单独）患者中，尿细胞学检查的 SN、SC、NPV 和 PPV 分别为 59%、93%、87% 和 50%，Xpert BC 监测仪的 SN、SC、NPV 和 PPV 分别为 90%、69%、95% 和 50% 。 Xpert BC 监测仪在孤立性 CIS 患者中漏检了 4 个肿瘤（NPV = 98%），同时在不确定或阴性的膀胱镜检查和 Xpert 结果阴性的情况下可能避免了 63.3% 的 TURBT。 结论 尿细胞学阳性可能提示膀胱癌，应认真对待。 Xpert BC 监测仪可能是一种有用的诊断工具，可用于正确识别孤立性 CIS 和膀胱镜检查无可疑或不确定的患者。