PDF(Pubmed)
Abstract：
BACKGROUND: 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.
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.
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.
摘要：
背景：与膀胱癌相关的高医疗保健成本的一个重要原因是需要频繁的膀胱镜检查来检测和监测该疾病。尿液标本的细胞学分析可以帮助，但不准确，无法取代膀胱镜检查。为了创造可靠的，目标,检测膀胱癌的非侵入性机制，已经开发了许多基于尿液的分子测试，其最终目标是减少膀胱镜检查的频率。
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。
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。
