title: A study of the reproducibility of a fluorescence in situ hybridization bladder cancer detection assay.
abstract: OBJECTIVE
  To assess the reproducibility of the UroVysion fluorescence in situ hybridization (FISH) bladder cancer detection assay.
  
  
  METHODS
  Thirteen specimens (2 negative, 3 low-level positive [1-10% abnormal cells], 5 mid-level positive [11-75%], and 3 high-level positive [>75%]) were analyzed by 7 cytotechnologists. Each cytotechnologist rendered an overall diagnosis of positive or negative and determined the percentage of abnormal urothelial cells for all positive specimens.
  
  
  RESULTS
  The interobserver reproducibility of the assay was 100% for mid-level and high-level positive specimens, 93% for negative specimens, and 78% for low-level positive specimens. The range of percent abnormal determinations was highest for mid-level positive specimens, with mean SDs of 1.8%, 16.4% and 10.1% for the low-, mid-, and high-level positives, respectively.
  
  
  CONCLUSIONS
  There was a high level of reproducibility among the mid- and high-level positive specimens. The reproducibility for low-level positive specimens was lowest, suggesting that such specimens should be reviewed by a second technologist to ensure an accurate diagnosis. The findings of this study are important for further elucidating the clinical value of quantitative FISH analysis in the management of patients undergoing FISH testing for bladder cancer.
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota 55905, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Brankley
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Adams
authors.forename: Michael R
authors.initials: MR
authors.lastname: Christensen
authors.forename: Cortney R
authors.initials: CR
authors.lastname: Everts
authors.forename: Jennifer D
authors.initials: JD
authors.lastname: Lund
authors.forename: Trynda N
authors.initials: TN
authors.lastname: Oberg
authors.forename: Amy M
authors.initials: AM
authors.lastname: Plagge
authors.forename: Angela H
authors.initials: AH
authors.lastname: Zieman
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Kipp
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Halling
mesh_terms: D002295:Carcinoma, Transitional Cell / Q000175:diagnosis* / Q000235:genetics / Q000652:urine; D002869:Chromosome Aberrations; D004273:DNA, Neoplasm / Q000032:analysis; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D015588:Observer Variation; D015203:Reproducibility of Results; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000652:urine; D019459:Urothelium / Q000473:pathology
chemical_list: D004273:DNA, Neoplasm