UBC^® <i>Rapid</i> Test—A Urinary Point-of-Care (POC) Assay for Diagnosis of Bladder Cancer with a focus on Non-Muscle Invasive High-Grade Tumors: Results of a Multicenter-Study

• Main Authors: Thorsten H. Ecke, Sarah Weiß, Carsten Stephan, Steffen Hallmann, Christian Arndt, Dimitri Barski, Thomas Otto, Holger Gerullis
• Format: Article
• Language: English
• Published: MDPI AG 2018-12-01
• Series: International Journal of Molecular Sciences
• Subjects: bladder cancer; tumor markers; urinary based diagnostics
• Online Access: https://www.mdpi.com/1422-0067/19/12/3841

Objectives: UBC^&#174; <i>Rapid</i> Test measures soluble fragments of cytokeratins 8 and 18 in urine. We present results of a multicenter study using an updated version of UBC^&#174; <i>Rapid</i> Test in bladder cancer patients, patients with urinary bladder cancer positive history, and healthy controls. Material and Methods: In total 530 urine samples have been included in this study. Clinical urine samples were used from 242 patients with tumors of the urinary bladder (134 non-muscle-invasive low-grade tumors (NMI-LG), 48 non-muscle-invasive high-grade tumors (NMI-HG), and 60 muscle-invasive high-grade tumors (MI-HG)), 62 patients with non-evidence of disease (NED), and 226 healthy controls. Urine samples were analyzed by the UBC^&#174; Rapid point-of-care (POC) assay and evaluated by Concile Omega 100 POC Reader. All statistical analyses have been performed using R version 3.2.3. Results: Elevated levels of UBC^&#174; Rapid Test in urine are higher in patients with bladder cancer in comparison to the control group (<i>p</i> &lt; 0.001). The sensitivity for the whole bladder cancer cohort was 53.3% (positive predictive value (PPV) 90.2%, negative predictive value (NPV) 65.2%) and was 38.8% (PPV 78.8%, NPV 72.1%) for non-muscle-invasive low-grade bladder cancer; 75.0% (PPV 72.0%, NPV 94.7%) for non-muscle-invasive high-grade bladder cancer and 68.3% (PPV 74.6%, NPV 91.8%) for muscle-invasive high-grade bladder cancer. The specificity for the statistical calculations was 93.8%. The cut-off value (10 &#181;g/L) was evaluated for the whole patient cohort. The area under the curve of the quantitative UBC^&#174; Rapid Test using the optimal threshold obtained by receiver operating characteristics (ROC) analysis was 0.774. Elevated values of UBC^&#174; <i>Rapid</i> Test in urine are higher in patients with high-grade bladder cancer in comparison to low-grade tumors and the healthy control group. Conclusions: UBC^&#174; <i>Rapid</i> Test has potential to be a clinically valuable urinary protein biomarker for detection of high-grade bladder cancer patients and could be added in the management of NMI-HG tumors. UBC^&#174; <i>Rapid</i> results generated in both study centers in the present multicenter study are very similar and reproducible. Furthermore UBC^&#174; <i>Rapid</i> Test is standardized and calibrated and thus independent of used batch of test as well as study site.