与膀胱癌相关的高医疗保健费用的一个重要原因是需要频繁进行膀胱镜检查来检测和监测这种疾病。对排泄尿液标本进行细胞学分析可以有所帮助，但不够准确，无法取代膀胱镜检查。为了创建可靠、客观、非侵入性的膀胱癌检测机制，已经开发了许多基于尿液的分子检测，最终目标是减少膀胱镜检查的频率。总结目前基于尿液的生物标志物检测的性能在美国市售，作为血尿和膀胱癌监测初步检查的一部分。根据 PRISMA 指南，我们对有关 NMP22、BTA、UroVysion、ImmunoCyt/uCyt、CxBladder 和膀胱 EpiCheck。根据纳入的研究计算每项测试的中位敏感性、特异性、阴性 (NPV) 和阳性预测值 (PPV)。28 项研究符合血尿检查中五项基于尿液的生物标志物测试的纳入标准。中位敏感性范围为 65.7% -100%，特异性范围为 62.5% -93.8%。中位 NPV 范围为 94.2% -98.3%，PPV 范围为 29% -58.7%。十四项研究符合膀胱癌监测中六项测试的纳入标准。中位敏感性范围为 22.6% -92.0%，特异性范围为 20.5% -97.9%。中位 NPV 范围为 52.9% -96.5%，PPV 范围为 48.1% -75.7%。我们的分析发现，虽然这些测试可能提供一些临床实用性，但迄今为止没有任何检测方法能够证明客观证据可以取代黄金诊断标准。© 2024 年——作者。由 IOS 出版社出版。

An important reason for the high health care costs associated with bladder cancer is the need for frequent cystoscopy for detection and surveillance of this disease. Cytologic analysis of voided urine specimens can assist, but is too inaccurate to replace cystoscopy. In an effort to create reliable, objective, noninvasive mechanisms for detecting bladder cancer, a number of urine-based molecular tests have been developed with the ultimate goal of reducing the frequency of cystoscopy.To summarize the performance of urine-based biomarker tests, currently commercially available in the US, as part of the initial workup for hematuria and for bladder cancer surveillance.In accordance with PRISMA guidelines we performed a systematic review of the literature on the performance of NMP22, BTA, UroVysion, ImmunoCyt/uCyt, CxBladder, and Bladder EpiCheck. Median sensitivity, specificity, negative (NPV) and positive predictive values (PPV) were calculated for each test based on the included studies.Twenty-eight studies met inclusion criteria for the performance of five urine-based biomarker tests in the setting hematuria workup. Median sensitivity ranged from 65.7% -100% and specificity ranged from 62.5% -93.8%. Median NPV ranged from 94.2% -98.3% and PPV ranged from 29% -58.7%. Fourteen studies met inclusion criteria for the performance of six tests in the setting of bladder cancer surveillance. Median sensitivity ranged from 22.6% -92.0% and specificity from 20.5% -97.9%. Median NPV ranged from 52.9% -96.5% and PPV ranged from 48.1% -75.7%.Our analysis finds that while these tests may provide some clinical utility, none of the assays have thus far demonstrated objective evidence to supplant the gold diagnostic standard.© 2024 – The authors. Published by IOS Press.