title: Reflex ImmunoCyt testing for the diagnosis of bladder cancer in patients with atypical urine cytology.
abstract: BACKGROUND
  ImmunoCyt/uCyt (Scimedx, Denville, NJ, USA) is a well-established urinary marker assay with high sensitivity for the diagnosis of urothelial carcinoma (UC) and can function as a second-level test to arbitrate atypical reads of urine cytology.
  
  
  OBJECTIVE
  To determine the utility of uCyt as a reflex test for atypical cytology in patients undergoing a hematuria evaluation or surveillance with a history of UC.
  
  
  METHODS
  The uCyt assay was performed as a second-level reflex test on all voided urine cytology tests read as atypical between January 2007 and June 2010 in an academic medical center. Records were retrospectively reviewed. Three hundred twenty-four patients underwent a total of 506 uCyt assays.
  
  
  METHODS
  Reflex uCyt assay on atypical urine cytology.
  
  
  METHODS
  The uCyt test characteristics include sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV).
  
  
  CONCLUSIONS
  Reflex uCyt was performed on 506 atypical voided urine samples that were followed by cystoscopy within 90 d. Reflex uCyt with a history of UC showed a sensitivity of 73%, a specificity of 49%, and an NPV of 80%. In those with a history of low-grade UC, reflex uCyt had a sensitivity of 75%, a specificity of 50%, and an NPV of 82%, while in those with a history of high-grade UC, it had a sensitivity of 74%, a specificity of 44%, and an NPV of 79%. Without prior history of UC, reflex uCyt had a sensitivity of 85%, a specificity of 59%, and an NPV of 94%. This study's limitations include its retrospective design and interobserver variability inherent to cystoscopy, which was used as the reference test.
  
  
  CONCLUSIONS
  When used as a reflex test on atypical urine cytology, negative uCyt may predict a negative cystoscopy in select patients and modulate the urgency and further work-up in those with no prior history or low-grade disease.
authors.affiliation: Department of Urology and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Anobel Y
authors.initials: AY
authors.lastname: Odisho
authors.forename: Anna B
authors.initials: AB
authors.lastname: Berry
authors.forename: Ardalan E
authors.initials: AE
authors.lastname: Ahmad
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Cooperberg
authors.forename: Peter R
authors.initials: PR
authors.lastname: Carroll
authors.forename: Badrinath R
authors.initials: BR
authors.lastname: Konety
mesh_terms: D000368:Aged; D001706:Biopsy; D002272:Carcinoembryonic Antigen / Q000652:urine*; D002277:Carcinoma / Q000175:diagnosis* / Q000473:pathology / Q000652:urine; D003558:Cystoscopy; D005260:Female; D005455:Fluorescent Antibody Technique; D006417:Hematuria / Q000175:diagnosis / Q000473:pathology / Q000652:urine; D006801:Humans; D008297:Male; D008875:Middle Aged; D009077:Mucins / Q000652:urine*; D060787:Neoplasm Grading; D015588:Observer Variation; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D016482:Urinalysis / Q000379:methods*; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000652:urine; D014556:Urine / Q000166:cytology
chemical_list: D002272:Carcinoembryonic Antigen; D009077:Mucins