{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T19:33:41Z","timestamp":1783625621802,"version":"3.55.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T00:00:00Z","timestamp":1709164800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study evaluates the efficacy of Acu\u2010URO17, a highly sensitive and specific immunocytochemistry (ICC) test targeting Keratin 17, in comparison to urine cytology and UroVysion\u2122 fluorescence in situ hybridization (FISH) for detecting bladder cancer cells in voided urine specimens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Acupath conducted a large\u2010scale comparison study using 2378 voided urine specimens. Acu\u2010URO17, urine cytology and UroVysion\u2122 FISH were performed on these specimens according to standardized protocols. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for Acu\u2010URO17 in comparison to urine cytology and UroVysion\u2122 FISH.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In cases diagnosed with high\u2010grade urothelial cancer via urine cytology, Acu\u2010URO17 demonstrated a sensitivity of 96% and a specificity of 82%. When compared to UroVysion\u2122 FISH results, Acu\u2010URO17 exhibited a sensitivity of 97.1% and a specificity of 77.8%, surpassing the sensitivity of UroVysion\u2122 FISH (57.1%). Notably, Acu\u2010URO17 showed a high NPV of 99.9%, indicating its reliability in confirming negative urine cytology results and risk\u2010stratifying atypical and suspicious cytology results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The results of this large\u2010scale prospective study support Acu\u2010URO17 as a clinically relevant, non\u2010invasive and cost\u2010effective tool for detecting bladder cancer cells in voided urine specimens. Its high sensitivity, specificity and NPV make it a valuable adjunct to urine cytology and UroVysion\u2122 FISH in the diagnosis and management of urothelial carcinoma (UC).<\/jats:p><\/jats:sec>","DOI":"10.1002\/bco2.338","type":"journal-article","created":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T02:04:00Z","timestamp":1709258640000},"page":"611-615","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Acu\u2010URO17 is a highly sensitive and specific bladder cancer biomarker"],"prefix":"10.1002","volume":"5","author":[{"given":"Liwu","family":"Guo","sequence":"first","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2550-2754","authenticated-orcid":false,"given":"Alexandra","family":"Cid","sequence":"additional","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Cucci","sequence":"additional","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Kunkel","sequence":"additional","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Defeis","sequence":"additional","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Matthews","sequence":"additional","affiliation":[{"name":"Acupath Laboratories Inc  Plainview New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,29]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Cancer facts & figures 2023","author":"American Cancer Society","year":"2023"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2023.03.013"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-030-88686-8"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.4103\/0970-1591.166445"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fsurg.2021.735868"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.21037\/tau-20-1363"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1515\/med-2023-0723"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000002135"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)67104-2"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-15-0293"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41379-018-0177-5"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqab050"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.7150\/jca.28989"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncy.20145"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1309\/K5P2-4Y8B-7L5A-FAA9"},{"key":"e_1_2_8_17_1","doi-asserted-by":"crossref","unstructured":"KippBR TanasescuM ElseTA BryantSC KarnesRJ SeboTJ et al.Quantitative fluorescence in situ hybridization and its ability to predict bladder cancer recurrence and progression to muscle\u2010invasive bladder cancer.2009;11(2):148\u2013154.https:\/\/doi.org\/10.2353\/jmoldx.2009.080096","DOI":"10.2353\/jmoldx.2009.080096"},{"key":"e_1_2_8_18_1","unstructured":"EuroVysion.Bladder cancer kit.2014. 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