Optimal urine-based diagnostic tests (UBDT) minimize unnecessary follow-up cystoscopies in patients with non-muscle-invasive bladder-cancer (NMIBC), while accurately detecting high-grade bladder-cancer without false-negative results. Such UBDTs have not been comprehensively described upon a broad, validated dataset, resulting in cautious guideline recommendations. Uromonitor®, a urine-based DNA-assay detecting hotspot alterations in TERT, FGFR3, and KRAS, shows promising initial results. However, a systematic review merging all available data is lacking. Studies investigating the diagnostic performance of Uromonitor®in NMIBC until November 2023 were identified in PubMed, Embase, Web-of-Science, Cochrane, Scopus, and medRxiv databases. Within aggregated analyses, test performance and area under the curve/AUC were calculated. This project fully implemented the PRISMA statement. Four qualifying studies comprised a total of 1190 urinary tests (bladder-cancer prevalence: 14.9%). Based on comprehensive analyses, sensitivity, specificity, positive-predictive value/PPV, negative-predictive value/NPV, and test accuracy of Uromonitor®were 80.2%, 96.9%, 82.1%, 96.6%, and 94.5%, respectively, with an AUC of 0.886 (95%-CI: 0.851–0.921). In a meta-analysis of two studies comparing test performance with urinary cytology, Uromonitor®significantly outperformed urinary cytology in sensitivity, PPV, and test accuracy, while no significant differences were observed for specificity and NPV. This systematic review supports the use of Uromonitor®considering its favorable diagnostic performance. In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.
理想的尿液诊断检测（UBDT）应能在准确检测高级别膀胱癌且不出现假阴性结果的同时，最大限度减少非肌层浸润性膀胱癌（NMIBC）患者不必要的后续膀胱镜检查。目前此类UBDT尚未在广泛验证的数据集上得到全面描述，导致指南推荐趋于保守。Uromonitor®作为一种基于尿液DNA检测技术，通过检测TERT、FGFR3和KRAS基因热点突变显示出良好的初步效果，但尚缺乏整合所有可用数据的系统性综述。本研究通过检索截至2023年11月PubMed、Embase、Web-of-Science、Cochrane、Scopus及medRxiv数据库中所有评估Uromonitor®在NMIBC诊断性能的研究，并严格遵循PRISMA声明进行系统分析。经筛选纳入的4项合格研究共包含1190例尿液检测样本（膀胱癌患病率为14.9%）。综合分析显示，Uromonitor®的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）及检测准确率分别为80.2%、96.9%、82.1%、96.6%和94.5%，曲线下面积（AUC）为0.886（95%置信区间：0.851–0.921）。在两项比较Uromonitor®与尿细胞学检测性能研究的荟萃分析中，Uromonitor®在敏感性、PPV和检测准确率方面显著优于尿细胞学检测，而特异性和NPV未见显著差异。本系统综述支持基于其良好诊断性能使用Uromonitor®。在1000例膀胱癌患病率约15%的患者队列中，该UBDT可避免825例不必要的膀胱镜检查（真阴性），但会漏诊30例膀胱癌（假阴性）。由于目前仅有的4项研究存在质量异质性且汇总数据有限，仍需开展验证性研究加以确认。
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