BTA stat®, NMP22® BladderChek®, UBC® Rapid Test, and CancerCheck® UBC® rapid VISUAL are urinary-based rapid tests. This multicenter study is the first study comparing all available rapid tests on a large cohort of bladder cancer patients and healthy controls in one setting.
In total 732 urine samples (second morning urine) in a real-world assessment have been analyzed. We evaluated clinical samples from 464 patients with histologically confirmed urothelial tumors of the urinary bladder (17 solitary CIS, 189 low-grade, 187 high-grade nonmuscle invasive, 71 high-grade muscle invasive), 77 patients with No Evidence of Disease (NED), and from 191 healthy controls. Urine samples were analyzed by the BTA stat®, NMP22® BladderChek®, UBC® Rapid Test point-of-care (POC) system using the concile Omega 100 POC reader, and CancerCheck® UBC® rapid VISUAL. Sensitivities and specificities were calculated by contingency analyses.
All investigated urinary markers detected more pathological concentrations in urine of bladder cancer patients compared to tumor-free patients. The calculated diagnostic sensitivities for BTA stat®, NMP22® BladderChek®, UBC® Rapid Test, CancerCheck® UBC® rapid VISUAL, and cytology were 62.4%, 13.4%, 58.2%, 28.6%, 36.2% for low-grade, 83.4%, 49.5%, 84.5%, 63.1%, 71.2% for high-grade nonmuscle invasive, and 95.8%, 35.2%, 76.1%, 50.7%, 67.7% for high-grade muscle-invasive bladder cancer. The specificity was 67.9%, 95.5%, 79.4%, 94.4%, and 83.7%, respectively. The area under the curve (AUC) after receiver operating characteristics (ROC) analysis for high-grade non-muscle-invasive tumors was 0.757, 0.725, 0.819, 0.787, and 0.774, respectively.
The analysis of more than 700 urine samples offers an objective view on urine-based rapid diagnostics. Elevated pathological concentrations of markers in urine of bladder cancer patients were detected in all investigated tests. The highest sensitivities for high-grade non-muscle-invasive tumors were calculated for BTA stat® and UBC® Rapid Test, whereas NMP22® BladderChek®, and cytology showed the highest specificities. BTA stat® and UBC® Rapid Test have the potential to be used as a clinical valuable urinary protein biomarker for the detection of high-grade non-muscle-invasive bladder cancer patients and could be included in the management of these tumors.
Urologic oncology. 2023 Jul 03 [Epub ahead of print]
Thorsten H Ecke, Christina J Meisl, Thorsten Schlomm, Anja Rabien, Flora Labonté, Dezhi Rong, Sebastian Hofbauer, Frank Friedersdorff, Lilli Sommerfeldt, Nella Gagel, Andreas Gössl, Dimitri Barski, Thomas Otto, Camilla M Grunewald, Günter Niegisch, Martin J P Hennig, Mario W Kramer, Stefan Koch, Jenny Roggisch, Steffen Hallmann, Sarah Weiß, Michael Waldner, Johannes Graff, Elke Veltrup, Friederike Linden, Roland Hake, Sebastian Eidt, Ralph M Wirtz
Department of Urology, Helios Hospital, Bad Saarow, Germany; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. Electronic address: ., Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Department of Urology, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany., Department of Urology, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany., Department of Urology, Rheinland Klinikum Neuss, Neuss, Germany., Department of Urology, Rheinland Klinikum Neuss, Neuss, Germany; University Hospital Essen, Essen, Germany., Department of Urology, University Hospital, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany., Department of Urology, University Hospital Lübeck, Lübeck, Germany., Helios Hospital, Institute of Pathology, Bad Saarow, Germany; Brandenburg Medical School, Brandenburg, Germany., Helios Hospital, Institute of Pathology, Bad Saarow, Germany., Department of Urology, Helios Hospital, Bad Saarow, Germany., Department of Urology, St. Elisabeth Hospital, Cologne, Germany., STRATIFYER Molecular Pathology GmbH, Cologne, Germany., Institute of Pathology, St. Elisabeth Hospital, Cologne, Germany.