title: A comparison of BTA stat, hemoglobin dipstick, telomerase and Vysis UroVysion assays for the detection of urothelial carcinoma in urine.
abstract: OBJECTIVE
  We determine the sensitivity and specificity of various assays for the detection of urothelial carcinoma.
  
  
  METHODS
  A total of 280 voided urine specimens from 265 patients were obtained immediately before cystoscopy for BTA stat, (Bard Diagnostic, Redmond, Washington) hemoglobin dipstick, (Bayer, Elkhart, Indiana) telomerase and UroVysion (Vysis, a wholly owned subsidiary of Abbott Laboratories, Abbott Park, Illinois) analysis.
  
  
  RESULTS
  Of the 265 patients 75 had biopsy proven urothelial carcinoma, and the sensitivity of the assays was determined from these patients. From most sensitive to least sensitive, the overall sensitivity of UroVysion (73 cases), BTA stat (72), hemoglobin dipstick (73) and telomerase (70) was 81%, 78%, 74%, and 46%, respectively. Each of the first 3 tests was statistically significantly more sensitive than the telomerase assay (p <0.05). However, the differences in overall sensitivity of UroVysion, BTA stat and hemoglobin dipstick were not statistically significant. The specificity of the tests was calculated for 80 of the 265 patients in this study who had no history of urothelial carcinoma and negative cystoscopy findings despite common urological complaints. From most specific to least specific, the specificity of UroVysion, telomerase, BTA stat and hemoglobin dipstick was 96%, 91%, 74% and 51%, respectively. UroVysion and telomerase were statistically significantly (p <0.01) more specific than the BTA stat and hemoglobin dipstick assays, and all of the assays were more specific than hemoglobin dipstick testing (p <0.001).
  
  
  CONCLUSIONS
  Our study reveals that UroVysion is the most sensitive and specific assay among those tested for the detection of urothelial carcinoma. Telomerase testing had good specificity but poor sensitivity. The BTA stat and hemoglobin dipstick tests had good sensitivity but relatively poor specificity. UroVysion is a promising new assay for the detection of urothelial carcinoma in urine specimens. However, further studies are needed to explore the role of the various assays in the treatment of patients with superficial urothelial carcinoma.
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, MN, USA.
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Halling
authors.forename: Walter
authors.initials: W
authors.lastname: King
authors.forename: Irina A
authors.initials: IA
authors.lastname: Sokolova
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Karnes
authors.forename: Reid G
authors.initials: RG
authors.lastname: Meyer
authors.forename: Eric L
authors.initials: EL
authors.lastname: Powell
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Sebo
authors.forename: John C
authors.initials: JC
authors.lastname: Cheville
authors.forename: Amy C
authors.initials: AC
authors.lastname: Clayton
authors.forename: Kelly L
authors.initials: KL
authors.lastname: Krajnik
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Ebert
authors.forename: Robert E
authors.initials: RE
authors.lastname: Nelson
authors.forename: Haleh M
authors.initials: HM
authors.lastname: Burkhardt
authors.forename: Sanjay
authors.initials: S
authors.lastname: Ramakumar
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Stewart
authors.forename: Vernon S
authors.initials: VS
authors.lastname: Pankratz
authors.forename: Michael M
authors.initials: MM
authors.lastname: Lieber
authors.forename: Michael L
authors.initials: ML
authors.lastname: Blute
authors.forename: Horst
authors.initials: H
authors.lastname: Zincke
authors.forename: Steven A
authors.initials: SA
authors.lastname: Seelig
authors.forename: Robert B
authors.initials: RB
authors.lastname: Jenkins
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: O'Kane
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000652:urine*; D014408:Biomarkers, Tumor; D001706:Biopsy; D002295:Carcinoma, Transitional Cell / Q000175:diagnosis* / Q000473:pathology / Q000652:urine; D003558:Cystoscopy; D005260:Female; D006452:Hemoglobinometry; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011934:Reagent Strips; D012680:Sensitivity and Specificity; D019098:Telomerase / Q000652:urine*; D001743:Urinary Bladder / Q000473:pathology; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000652:urine
chemical_list: D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; D011934:Reagent Strips; C112999:bladder tumor-associated antigen; D019098:Telomerase