Heard John R, Mitra Anirban P
Department of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Department of Computational Biomedicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Bladder Cancer. 2024 Mar 12;10(1):71-81. doi: 10.3233/BLC-230096. eCollection 2024.
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.
与膀胱癌相关的医疗保健成本高昂的一个重要原因是需要频繁进行膀胱镜检查以检测和监测这种疾病。对排尿尿液标本进行细胞学分析可能会有所帮助，但准确性太差，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，已经开发了一些基于尿液的分子检测方法，其最终目标是减少膀胱镜检查的频率。
总结目前在美国可商购的基于尿液的生物标志物检测方法作为血尿初步检查和膀胱癌监测的一部分的性能。
根据PRISMA指南，我们对有关NMP22、BTA、UroVysion、ImmunoCyt/uCyt、CxBladder和Bladder EpiCheck性能的文献进行了系统综述。根据纳入的研究计算每个检测方法的中位敏感性、特异性、阴性（NPV）和阳性预测值（PPV）。
28项研究符合在血尿检查中进行5种基于尿液的生物标志物检测性能的纳入标准。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%。14项研究符合在膀胱癌监测中进行6种检测性能的纳入标准。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，虽然这些检测方法可能具有一定的临床实用性，但迄今为止，没有一种检测方法能证明有客观证据可取代金诊断标准。
