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两种用于检测和监测尿路上皮癌的非侵入性基因检测的临床评估:UroVysion和Xpert膀胱癌检测试验的验证

Clinical Evaluation of Two Non-Invasive Genetic Tests for Detection and Monitoring of Urothelial Carcinoma: Validation of UroVysion and Xpert Bladder Cancer Detection Test.

作者信息

Kavcic Niko, Peric Ivan, Zagorac Andreja, Kokalj Vokac Nadja

机构信息

Department of Urology, University Medical Centre Maribor, Maribor, Slovenia.

Laboratory of Medical Genetics, University Medical Centre Maribor, Maribor, Slovenia.

出版信息

Front Genet. 2022 Jun 6;13:839598. doi: 10.3389/fgene.2022.839598. eCollection 2022.

DOI:10.3389/fgene.2022.839598
PMID:35734425
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9208547/
Abstract

A variety of commercially available urinary molecular markers have been introduced for detecting and monitoring urothelial carcinoma (UC). We prospectively evaluated the UroVysion Bladder Cancer Kit (FISH) and the Xpert® Bladder Cancer Detection (Xpert) test. Both tests were performed on voided urine samples after negative cystoscopy and negative abdominal ultrasound (US) and/or negative computed tomography urography (CTU). Urine specimens from 156 patients diagnosed with hematuria and suspected of having UC and 48 patients followed up after treatment of UC were analyzed using FISH and Xpert. Among 204 patients, 20 had UC, 11 located in the bladder, six in the ureter, and three in the renal pelvis. FISH had an overall sensitivity (SN) of 78%, a specificity (SP) of 93%, and a negative predictive value (NPV) of 96%. Xpert had an overall SN of 90%, an SP of 85%, and an NPV of 98%. Both tests had high SN, SP, and NPV. The SP of FISH was significantly higher. By using FISH and Xpert in addition to cystoscopy, renal and bladder US, and/or CTU in the diagnostic workup of patients with hematuria and follow-up after transurethral resection of the bladder (TURB), a substantial number of patients (10%) otherwise missed were discovered to have UC.

摘要

为了检测和监测尿路上皮癌(UC),已经引入了多种市售的尿液分子标志物。我们前瞻性地评估了UroVysion膀胱癌检测试剂盒(荧光原位杂交法)和Xpert®膀胱癌检测(Xpert)测试。这两种测试均在膀胱镜检查阴性、腹部超声(US)阴性和/或计算机断层扫描尿路造影(CTU)阴性后的排尿尿液样本上进行。使用荧光原位杂交法和Xpert对156例诊断为血尿并疑似患有UC的患者以及48例UC治疗后随访的患者的尿液标本进行了分析。在204例患者中,20例患有UC,其中11例位于膀胱,6例位于输尿管,3例位于肾盂。荧光原位杂交法的总体敏感性(SN)为78%,特异性(SP)为93%,阴性预测值(NPV)为96%。Xpert的总体SN为90%,SP为85%,NPV为98%。两种测试均具有较高的SN、SP和NPV。荧光原位杂交法的SP显著更高。在血尿患者的诊断检查以及经尿道膀胱肿瘤电切术(TURB)后的随访中,除了膀胱镜检查、肾脏和膀胱超声以及/或CTU外,使用荧光原位杂交法和Xpert,发现大量原本会漏诊的患者(10%)患有UC。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1727/9208547/549ff095d48e/fgene-13-839598-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1727/9208547/549ff095d48e/fgene-13-839598-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1727/9208547/549ff095d48e/fgene-13-839598-g001.jpg

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