title: The value of the UroVysion® FISH assay in the risk-stratification of patients with "atypical urothelial cells" in urinary cytology specimens.
abstract: BACKGROUND
  The aim of this study was to evaluate the potential use of the UroVysion® fluorescent in situ hybridization test (U-FISH) to stratify the risk of urothelial carcinoma (UC) in patients with a diagnosis of "atypical urothelial cells" (AUC) in urinary tract cytology (UTCy).
  
  
  METHODS
  Using a histologic diagnosis of UC and respectively of high grade UC (HGUC) within 12 months of the index UTCy as a reference standard, we determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of U-FISH for patients with AUC diagnosed 2008 to 2014.
  
  
  RESULTS
  Of the 377 patients with AUC, 62 (16.45%) were diagnosed with UC (29 low grade UC and 33 HGUC) within 12 months. U-FISH were uninformative in 45 (11.94%), positive in 63 (16.71%) and negative in 269 (71.35%). UC was diagnosed more frequently in patients with positive than in those with negative U- FISH results (31/63, 49.21% vs. 25/269, 9.29%, P < 0.0001). The sensitivity, specificity, PPV, NPV and accuracy of U-FISH in the setting of AUC were 44.64%, 81.82%, 47.17%, 80.25%, and 71.91% for UC and respectively 48.39%, 78.77%. 28.3%, 89.81%, and 74.29% for HGUC. U-FISH showed a high false positive rate (28/53, 52.83%) that remained high even after extended follow-up, arguing against "anticipatory positive" results.
  
  
  CONCLUSIONS
  U-FISH allows risk stratification in patients with AUC. However, its usefulness is diminished by the high false-positive rate, making it important to interpret U- FISH results in the patient's clinical context. Diagn. Cytopathol. 2017;45:481-500. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Renu K
authors.initials: RK
authors.lastname: Virk
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Schuharazad
authors.initials: S
authors.lastname: Abro
authors.affiliation: Department of Pathology, Northwestern University, Chicago, IL.
authors.forename: Julianne Muus Martinez
authors.initials: JMM
authors.lastname: de Ubago
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Stefan E
authors.identifier: http://orcid.org/0000-0001-6020-0176
authors.initials: SE
authors.lastname: Pambuccian
authors.affiliation: Department of Urology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Marcus L
authors.initials: ML
authors.lastname: Quek
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Eva M
authors.initials: EM
authors.lastname: Wojcik
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Swati
authors.initials: S
authors.lastname: Mehrotra
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Grazina U
authors.initials: GU
authors.lastname: Chatt
authors.affiliation: Department of Pathology, Loyola University Medical Center, Maywood, IL, 60153.
authors.forename: Güliz A
authors.initials: GA
authors.lastname: Barkan
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000652:urine; D002277:Carcinoma / Q000473:pathology* / Q000652:urine; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods / Q000592:standards*; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000592:standards*; D060787:Neoplasm Grading; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000473:pathology* / Q000652:urine; D019459:Urothelium / Q000473:pathology*
chemical_list: D014408:Biomarkers, Tumor
keywords: FISH; STARD; UroVysion®; sensitivity; specificity; urine cytology; urothelial carcinoma