title: Preliminary Results of a Multicentre Study of the UBC Rapid Test for Detection of Urinary Bladder Cancer.
abstract: OBJECTIVE
  UBC Rapid is a test detecting fragments of cytokeratins 8 and 18 in urine. These are cytokeratins frequently overexpressed in tumor cells. We present the first results of a multi-centre study using UBC Rapid in patients with bladder cancer and healthy controls.
  
  
  METHODS
  Clinical urine samples from 92 patients with tumors of the urinary bladder (45 low-grade and 47 high-grade tumors) and from 33 healthy controls were used. Urine samples were analyzed by the UBC Rapid point-of-care (POC) system and evaluated both visually and quantitatively using a concile Omega 100 POC reader. For visual evaluation, different thresholds of band intensity for considering a test as positive were applied. Sensitivities and specificities were calculated by contingency analyses.
  
  
  RESULTS
  We found that pathological concentrations by UBC Rapid are detectable in urine of patients with bladder cancer. The calculated diagnostic sensitivity of UBC Rapid in urine was 68.1% for high-grade, but only 46.2% for low-grade tumors. The specificity was 90.9%. The area under the curve (AUC) after receiver-operated curve (ROC) analysis was 0.733. Pathological levels of UBC Rapid in urine are higher in patients with bladder cancer in comparison to the control group (p<0.0001).
  
  
  CONCLUSIONS
  UBC rapid can differentiate between patients with bladder cancer and controls. Further studies with a greater number of patients will show how valuable these results are.
authors.affiliation: HELIOS Hospital, Department of Urology, Bad Saarow, Germany thorsten.ecke@helios-kliniken.de.
authors.forename: Thorsten H
authors.initials: TH
authors.lastname: Ecke
authors.affiliation: Lukaskrankenhaus Neuss, Department of Urology, Neuss, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Arndt
authors.affiliation: Department of Urology, Charité University Hospital, Berlin, Germany Berlin Institute for Urological Research, Berlin, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Stephan
authors.affiliation: HELIOS Hospital, Department of Urology, Bad Saarow, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Hallmann
authors.affiliation: HELIOS Hospital, Department of Urology, Bad Saarow, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Lux
authors.affiliation: Lukaskrankenhaus Neuss, Department of Urology, Neuss, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Otto
authors.affiliation: HELIOS Hospital, Department of Urology, Bad Saarow, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Ruttloff
authors.affiliation: Lukaskrankenhaus Neuss, Department of Urology, Neuss, Germany School of Medicine and Health Sciences Carl von Ossietzky, University Oldenburg, Oldenburg, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Gerullis
mesh_terms: D000368:Aged; D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor / Q000652:urine*; D005260:Female; D006801:Humans; D053538:Keratin-18 / Q000652:urine*; D053533:Keratin-8 / Q000652:urine*; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000652:urine*
chemical_list: D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; D053538:Keratin-18; D053533:Keratin-8
keywords: UBC Rapid Test; Urinary bladder cancer; tumor marker