title: Detection of bladder cancer using a point-of-care proteomic assay.
abstract: BACKGROUND
  A combination of methods is used for diagnosis of bladder cancer because no single procedure detects all malignancies. Urine tests are frequently part of an evaluation, but have either been nonspecific for cancer or required specialized analysis at a laboratory.
  
  
  OBJECTIVE
  To investigate whether a point-of-care proteomic test that measures the nuclear matrix protein NMP22 in voided urine could enhance detection of malignancy in patients with risk factors or symptoms of bladder cancer.
  
  
  METHODS
  Twenty-three academic, private practice, and veterans' facilities in 10 states prospectively enrolled consecutive patients from September 2001 to May 2002. Participants included 1331 patients at elevated risk for bladder cancer due to factors such as history of smoking or symptoms including hematuria and dysuria. Patients at risk for malignancy of the urinary tract provided a voided urine sample for analysis of NMP22 protein and cytology prior to cystoscopy.
  
  
  METHODS
  The diagnosis of bladder cancer, based on cystoscopy with biopsy, was accepted as the reference standard. The performance of the NMP22 test was compared with voided urine cytology as an aid to cancer detection. Testing for the NMP22 tumor marker was conducted in a blinded manner.
  
  
  RESULTS
  Bladder cancer was diagnosed in 79 patients. The NMP22 assay was positive in 44 of 79 patients with cancer (sensitivity, 55.7%; 95% confidence interval [CI], 44.1%-66.7%), whereas cytology test results were positive in 12 of 76 patients (sensitivity, 15.8%; 95% CI, 7.6%-24.0%). The specificity of the NMP22 assay was 85.7% (95% CI, 83.8%-87.6%) compared with 99.2% (95% CI, 98.7%-99.7%) for cytology. The proteomic marker detected 4 cancers that were not visualized during initial endoscopy, including 3 that were muscle invasive and 1 carcinoma in situ.
  
  
  CONCLUSIONS
  The noninvasive point-of-care assay for elevated urinary NMP22 protein can increase the accuracy of cystoscopy, with test results available during the patient visit.
authors.affiliation: Department of Urology, M.D. Anderson Cancer Center, Houston, Tex 77030, USA. HBGrossman@mdanderson.org
authors.forename: H Barton
authors.initials: HB
authors.lastname: Grossman
authors.forename: Edward
authors.initials: E
authors.lastname: Messing
authors.forename: Mark
authors.initials: M
authors.lastname: Soloway
authors.forename: Kevin
authors.initials: K
authors.lastname: Tomera
authors.forename: Giora
authors.initials: G
authors.lastname: Katz
authors.forename: Yitzhak
authors.initials: Y
authors.lastname: Berger
authors.forename: Yu
authors.initials: Y
authors.lastname: Shen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor / Q000652:urine*; D001706:Biopsy; D003558:Cystoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009687:Nuclear Proteins / Q000652:urine*; D019095:Point-of-Care Systems; D020543:Proteome / Q000032:analysis*; D040901:Proteomics; D012680:Sensitivity and Specificity; D016482:Urinalysis; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000652:urine
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D009687:Nuclear Proteins; D020543:Proteome; C100379:nuclear matrix protein 22