PMID- 36434570 OWN - NLM STAT- MEDLINE DCOM- 20221129 LR - 20230320 IS - 1471-2490 (Electronic) IS - 1471-2490 (Linking) VI - 22 IP - 1 DP - 2022 Nov 25 TI - Diagnostic performance of an immunoassay based on urine exfoliated cell enrichment nanotechnology for upper tract urothelial carcinoma: a retrospective, monocentric study. PG - 194 LID - 10.1186/s12894-022-01122-4 [doi] LID - 194 AB - BACKGROUND: Noninvasively urine-based diagnostic modalities for upper urinary tract urothelial carcinoma (UTUC) were still lacking. We evaluated the diagnostic value of our previously developed urine-based assay (UTC assay) in UTUC. METHODS: We retrospectively analyzed 90 patients with suspected UTUC and 40 donors without UTUC. Voided urine specimens were analyzed by UTC assay and fluorescence in situ hybridization (FISH). The performance of UTC assay and FISH was compared among the 60 histologically proven UTUC patients and the 40 donors with benign disease. RESULTS: Of the 60 UTUCs, there were 8 low-grade and 52 high-grade cases. Overall sensitivity for UTC assay and FISH were 85% and 73.3%, respectively (P = 0.116). Specificities for UTC assay and FISH were 92.5% and 95%, respectively (P = ns.). By grade, sensitivities of UTC assay and FISH were 87.5% vs. 37.5% for low-grade (P = 0.119), and 84.6% vs. 78.8% for high- grade UTUC (P = 0.446), respectively. By stage, UTC assay showed significantly higher sensitivity than FISH for detecting non-muscle-invasive UTUC, which were 88.5% vs. 61.5%, respectively (P = 0.025). CONCLUSION: UTC assay has good performance for the non-invasive diagnosis of UTUC. UTC assay may improve the diagnosis and surveillance of low-grade or superficial UTUC. CI - (c) 2022. The Author(s). FAU - Wang, Xin AU - Wang X AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. FAU - Zhang, Shiwei AU - Zhang S AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. FAU - Wu, Lang AU - Wu L AD - PerMed Biomedicine Institute, 201321, Shanghai, China. FAU - Feng, Baofu AU - Feng B AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. FAU - Shen, Hongwei AU - Shen H AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. FAU - Gu, Yuanyuan AU - Gu Y AD - PerMed Biomedicine Institute, 201321, Shanghai, China. FAU - Zhang, Qun AU - Zhang Q AD - PerMed Biomedicine Institute, 201321, Shanghai, China. FAU - Fang, Feng AU - Fang F AD - Department of Pharmacology, Nanjing Medical University, 210000, Nanjing, Jiangsu, China. FAU - Yang, Rong AU - Yang R AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. doctoryr@gmail.com. FAU - Guo, Hongqian AU - Guo H AD - Department of Urology, Institute of Urology, Drum Tower Hospital, Medical School of Nanjing University, Nanjing University, 321 Zhongshan Rd, 210008, Nanjing, Jiangsu, China. dr.ghq@nju.edu.cn. LA - eng GR - 81772727 and 81772710/National Natural Science Foundation of China/ GR - ZDXKB2016014/The Project of Invigorating Health Care through Science, Technology and Education, Jiangsu Provincial Key Medical Discipline (Laboratory)/ PT - Journal Article DEP - 20221125 PL - England TA - BMC Urol JT - BMC urology JID - 100968571 SB - IM CIN - Nat Rev Urol. 2023 Jan;20(1):8. PMID: 36477221 MH - Humans MH - *Carcinoma, Transitional Cell/diagnosis/pathology MH - *Urinary Bladder Neoplasms/pathology MH - Retrospective Studies MH - In Situ Hybridization, Fluorescence MH - Immunoassay MH - Nanotechnology PMC - PMC9700989 OTO - NOTNLM OT - FISH OT - Immunocytology OT - Upper urinary tract OT - Urine OT - Urothelial carcinoma COIS- The authors declare that they have no competing interests. EDAT- 2022/11/27 06:00 MHDA- 2022/11/30 06:00 PMCR- 2022/11/25 CRDT- 2022/11/26 11:47 PHST- 2022/08/03 00:00 [received] PHST- 2022/10/12 00:00 [accepted] PHST- 2022/11/26 11:47 [entrez] PHST- 2022/11/27 06:00 [pubmed] PHST- 2022/11/30 06:00 [medline] PHST- 2022/11/25 00:00 [pmc-release] AID - 10.1186/s12894-022-01122-4 [pii] AID - 1122 [pii] AID - 10.1186/s12894-022-01122-4 [doi] PST - epublish SO - BMC Urol. 2022 Nov 25;22(1):194. doi: 10.1186/s12894-022-01122-4.