OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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%.
CONCLUSIONS: 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.
目的:总结基于尿液的生物标志物测试的性能,目前在美国商用,作为血尿和膀胱癌监测的初步检查的一部分。
方法:根据PRISMA指南,我们对NMP22,BTA,UroVysion,ImmunoCyt/uCyt,膀胱,和膀胱EpiCheck。中值灵敏度,特异性,根据纳入的研究,计算各项试验的阴性预测值(NPV)和阳性预测值(PPV).
结果:28项研究符合血尿检查中5项基于尿液的生物标志物检测的纳入标准。中位敏感性为65.7%-100%,特异性为62.5%-93.8%。净现值中位数为94.2%-98.3%,PPV为29%-58.7%。14项研究符合在膀胱癌监测中进行6项测试的纳入标准。中位敏感性为22.6%-92.0%,特异性为20.5%-97.9%。净现值中位数为52.9%-96.5%,PPV为48.1%-75.7%。
结论:我们的分析发现,虽然这些测试可能提供一些临床应用,到目前为止,没有任何一种检测方法能证明客观证据可以取代黄金诊断标准。