Noninvasive Tests for Bladder Cancer Detection and Surveillance: A Systematic Review of Commercially Available Assays

IF 1 4区医学 Q4 ONCOLOGY Bladder Cancer Pub Date : 2024-02-14 DOI:10.3233/blc-230096

John R. Heard, Anirban P. Mitra

{"title":"Noninvasive Tests for Bladder Cancer Detection and Surveillance: A Systematic Review of Commercially Available Assays","authors":"John R. Heard, Anirban P. Mitra","doi":"10.3233/blc-230096","DOIUrl":null,"url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>\nAn 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.</p><h3><span></span>OBJECTIVE:</h3><p>\nTo 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.</p><h3><span></span>METHODS:</h3><p>\nIn 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.</p><h3><span></span>RESULTS:</h3><p>\nTwenty-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% .</p><h3><span></span>CONCLUSIONS:</h3><p>\nOur 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.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bladder Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3233/blc-230096","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

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.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

用于膀胱癌检测和监控的无创检验：市售检测方法系统回顾

摘要背景：与膀胱癌相关的医疗费用高昂的一个重要原因是需要经常进行膀胱镜检查，以发现和监测这种疾病。对排出的尿液标本进行细胞学分析可以起到辅助作用，但其准确性太低，无法取代膀胱镜检查。为了建立可靠、客观、无创的膀胱癌检测机制，人们开发了许多基于尿液的分子检测方法，最终目的是减少膀胱镜检查的频率。方法：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回顾。结果：28 项研究符合血尿检查中五项尿液生物标记物检测的纳入标准。灵敏度中位数介于 65.7% -100% 之间，特异性介于 62.5% -93.8% 之间。中位 NPV 在 94.2% -98.3% 之间，PPV 在 29% -58.7% 之间。有 14 项研究符合膀胱癌监测中六项检测的纳入标准。灵敏度中位数在 22.6% -92.0% 之间，特异性在 20.5% -97.9% 之间。中位 NPV 为 52.9% -96.5%，PPV 为 48.1% -75.7% .结论：我们的分析发现，虽然这些检测可能会提供一些临床实用性，但迄今为止还没有任何一种检测能证明其具有取代黄金诊断标准的客观证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Bladder Cancer Medicine-Urology

CiteScore

1.60

自引率

0.00%

发文量

期刊介绍： Bladder Cancer is an international multidisciplinary journal to facilitate progress in understanding the epidemiology/etiology, genetics, molecular correlates, pathogenesis, pharmacology, ethics, patient advocacy and survivorship, diagnosis and treatment of tumors of the bladder and upper urinary tract. The journal publishes research reports, reviews, short communications, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research in basic science, translational research and clinical medicine that expedites our fundamental understanding and improves treatment of tumors of the bladder and upper urinary tract.