title: Measurements of complement factor H-related protein (BTA-TRAK assay) and nuclear matrix protein (NMP22 assay)--useful diagnostic tools in the diagnosis of urinary bladder cancer?
abstract: Between 1997 and 2000 we investigated in a prospective study the voided urine samples of all consecutive patients undergoing cystoscopy independent from their clinical background (n = 705) with the BTA-TRAK assay (Bard Diagnostics, Redmont, USA) detecting a complement factor H-related protein (CFHrP) and the NMP22 assay (Matritech, Newton, USA) measuring a nuclear matrix protein, which is supposed to be specific for bladder cancer. The individuals were divided into three groups concerning the clinical background: 233 patients had urological diseases, 268 patients had urinary bladder cancer and 150 patients had other urological malignancies. Based on the clinical findings we compared our results with well established diagnostic methods for urinary bladder cancer such as cytology and the detection of hematuria. In addition, we investigated urine samples from 30 healthy individuals and 24 patients with urinary tract infection without performing cystoscopy. Following the recommendations of the European Group on Tumor Markers we used 95% specificity for benign urological diseases and urinary tract infections, which resulted in a sensitivity of 17% for active bladder cancer for the BTA-TRAK assay and 31% for NMP22. We compared these results with the detection of hematuria (specificity: 72%) and cytology, which had a sensitivity of 64% and 89%, respectively. Subsequently, we calculated sensitivity and specificity for the detection of relapse of the disease. Again using 95% specificity, in this case for patients with no evidence of disease (NED), in patients with recurrent disease the BTA-TRAK assay showed 8% sensitivity as compared to 12% for the NMP22 assay. Due to an insufficient specificity and sensitivity, both tests can neither be clinically useful in screening of high risk patients, nor in primary diagnosis of bladder cancer. They cannot replace neither cystoscopy nor cytology. In the follow-up care more investigations may be necessary to prove the benefit of existing diagnostic strategies for the discrimination between active and inactive bladder cancer.
authors.affiliation: Institute of Clinical Chemistry, University of Munich, Munich, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Mahnert
authors.forename: Stephan
authors.initials: S
authors.lastname: Tauber
authors.forename: Martin
authors.initials: M
authors.lastname: Kriegmair
authors.forename: Dorothea
authors.initials: D
authors.lastname: Nagel
authors.forename: Stefan
authors.initials: S
authors.lastname: Holdenrieder
authors.forename: Karin
authors.initials: K
authors.lastname: Hofmann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Reiter
authors.forename: Nikolaus
authors.initials: N
authors.lastname: Schmeller
authors.forename: Petra
authors.initials: P
authors.lastname: Stieber
mesh_terms: D014408:Biomarkers, Tumor / Q000652:urine; D016022:Case-Control Studies; D017242:Complement Factor H / Q000652:urine*; D003558:Cystoscopy; D003937:Diagnosis, Differential; D006417:Hematuria; D006801:Humans; D007124:Immunoenzyme Techniques; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000473:pathology / Q000652:urine; D009687:Nuclear Proteins / Q000652:urine*; D011379:Prognosis; D011446:Prospective Studies; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000652:urine; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000473:pathology / Q000652:urine; D014556:Urine / Q000166:cytology; D014570:Urologic Diseases / Q000175:diagnosis / Q000473:pathology / Q000652:urine
chemical_list: D014408:Biomarkers, Tumor; C493495:CFH protein, human; D009687:Nuclear Proteins; D011933:Reagent Kits, Diagnostic; C100379:nuclear matrix protein 22; D017242:Complement Factor H