最佳基于尿液的诊断测试(UBDT)可最大程度地减少非肌层浸润性膀胱癌(NMIBC)患者不必要的膀胱镜检查,同时准确检测高级别膀胱癌,没有假阴性结果。这样的UBDT还没有得到广泛的全面描述,已验证的数据集,导致谨慎的指导方针建议。Uromonitor®,一种基于尿液的DNA检测方法,检测TERT中的热点改变,FGFR3和KRAS,显示了有希望的初步结果。然而,缺乏合并所有可用数据的系统审查。调查Uromonitor®在NMIBC中的诊断性能直到2023年11月的研究在PubMed中确定,Embase,Web-of-Science,科克伦,Scopus,和medRxiv数据库。在汇总分析中,计算测试性能和曲线下面积/AUC。该项目完全执行了PRISMA声明。四项合格研究共包括1190次尿检(膀胱癌患病率:14.9%)。在综合分析的基础上,灵敏度,特异性,阳性预测值/PPV,阴性预测值/净现值,Uromonitor®的测试精度为80.2%,96.9%,82.1%,96.6%,94.5%,分别,AUC为0.886(95%-CI:0.851-0.921)。在两项研究的荟萃分析中,将测试性能与尿细胞学进行了比较,Uromonitor®的敏感性明显优于尿细胞学,PPV,和测试精度,而特异性和NPV没有观察到显著差异。考虑到Uromonitor®的良好诊断性能,本系统评价支持使用Uromonitor®。在1000名膀胱癌患病率约为15%的患者中,这种UBDT可以避免825例不必要的膀胱镜检查(真阴性),同时错过30例膀胱癌病例(假阴性).由于目前只有四项具有异质质量的研究的汇总数据有限,需要进行验证性研究。
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.