caa a22 4500 378869647 CHVBK 20180305123406.0 cr unu---uuuuu 161128e20030127xx s 000 0 eng 10.1515/CCLM.2003.018 doi (NATIONALLICENCE)gruyter-10.1515/CCLM.2003.018 Measurements of Complement Factor H-RelatedProtein (BTA-TRAK™ Assay) and Nuclear MatrixProtein (NMP22 Assay) - Useful Diagnostic Toolsin the Diagnosis of Urinary Bladder Cancer? [Elektronische Daten] [Brigitte Mahnert, Stephan Tauber, Martin Kriegmair, Dorothea Nagel, Stefan Holdenrieder, Karin Hofmann, Wolfgang Reiter, Nikolaus Schmeller, Petra Stieber] 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. Copyright © 2003 by Walter de Gruyter GmbH & Co. KG Medical equipment & techniques nationallicence Medical diagnosis nationallicence Diseases & disorders nationallicence Mahnert Brigitte aut Tauber Stephan aut Kriegmair Martin aut Nagel Dorothea aut Holdenrieder Stefan aut Hofmann Karin aut Reiter Wolfgang aut Schmeller Nikolaus aut Stieber Petra aut Clinical Chemistry and Laboratory Medicine Walter de Gruyter 41/1(2003-01-27), 104-110 1434-6621 41:1<104 2003 41 cclm https://doi.org/10.1515/CCLM.2003.018 text/html Onlinezugriff via DOI 1 research article jats NATIONALLICENCE 856 40 https://doi.org/10.1515/CCLM.2003.018 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Mahnert Brigitte aut NATIONALLICENCE 700 1- Tauber Stephan aut NATIONALLICENCE 700 1- Kriegmair Martin aut NATIONALLICENCE 700 1- Nagel Dorothea aut NATIONALLICENCE 700 1- Holdenrieder Stefan aut NATIONALLICENCE 700 1- Hofmann Karin aut NATIONALLICENCE 700 1- Reiter Wolfgang aut NATIONALLICENCE 700 1- Schmeller Nikolaus aut NATIONALLICENCE 700 1- Stieber Petra aut NATIONALLICENCE 773 0- Clinical Chemistry and Laboratory Medicine Walter de Gruyter 41/1(2003-01-27), 104-110 1434-6621 41:1<104 2003 41 cclm CC0 http://creativecommons.org/publicdomain/zero/1.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-gruyter