UBC^®RapidTest for detection of carcinoma in situ for bladder cancer

Abstract

UBC Rapid Test is a test that detects fragments of cytokeratins 8 and 18 in urine. We present results of a multicentre study measuring UBC Rapid Test in bladder cancer patients and healthy controls with focus on carcinoma in situ (CIS) and high-grade bladder cancer. From our study with N = 452 patients, we made a stratified sub-analysis for carcinoma in situ of the urinary bladder. Clinical urine samples were used from 87 patients with tumours of the urinary bladder (23 carcinoma in situ, 23 non-muscle-invasive low-grade tumours, 21 non-muscle-invasive high-grade tumours and 20 muscle-invasive high-grade tumours) and from 22 healthy controls. The cut-off value was defined at 10.0 µg/L. Urine samples were analysed by the UBC Rapid Test point-of-care system (concile Omega 100 POC reader). Pathological levels of UBC Rapid Test in urine are higher in patients with bladder cancer in comparison to the control group (p < 0.001). Sensitivity was calculated at 86.9% for carcinoma in situ, 30.4% for non-muscle-invasive low-grade bladder cancer, 71.4% for nonmuscle-invasive high grade bladder cancer and 60% for muscle-invasive high-grade bladder cancer, and specificity was 90.9%. The area under the curve of the quantitative UBC Rapid Test using the optimal threshold obtained by receiveroperated curve analysis was 0.75. Pathological values of UBC Rapid Test in urine are higher in patients with high-grade bladder cancer in comparison to low-grade tumours and the healthy control group. UBC Rapid Test has potential to be more sensitive and specific urinary protein biomarker for accurate detection of high-grade patients and could be added especially in the diagnostics for carcinoma in situ and non-muscle-invasive high-grade tumours of urinary bladder cancer.

Evaluation of a New Survivin ELISA and UBC® Rapid for the Detection of Bladder Cancer in Urine

“…This is in accordance with other reports showing sensitivities in the range of 53–64% and specificities in the range of 63–91% [ 46 , 47 , 48 , 49 , 50 , 51 ]. Similar to survivin, UBC ® Rapid also has a higher sensitivity for high-grade tumors [ 46 , 50 , 51 , 52 ] in comparison to low-grade tumors, indicating that the UBC ® Rapid test may be more useful for this subgroup. The test may be influenced by urinary tract infections as has been shown before [ 53 ].…”

Diagnostic accuracy of the UBC� Rapid Test for bladder cancer: A meta‑analysis

“…1 ), a total of 14 potential relevant articles were identified initially, of which four were removed subsequent to reading the titles and abstracts in further detail. Following a full-text review, two studies were eliminated due to lack of sufficient data, leaving eight studies ( 14 – 16 , 22 , 31 – 34 ). The basic characteristics of the studies are summarized in Table I .…”

“…These cytokeratins are located in the cytoskeleton of epithelial cells and tend to be overexpressed in urothelial tumor types including bladder cancer ( 17 – 19 ). Based on this, several trials have been performed to investigate the efficacy of the UBC ® Rapid Test in the detection and follow-up of bladder cancer ( 20 – 22 ). However, differences in the design and enrollment of these studies have resulted in inconsistent conclusions, so its diagnostic accuracy remains unclear.…”

Novel urinary biomarkers for the detection of bladder cancer: A systematic review

“…Four studies reported the diagnostic ability of proteins cytokeratin and 18 using the UBC Rapid point of care Omega 100 reader [63][64][65][66] A combination of urinary cytology, midkine (NEGF2) and gamma synuclein quantification using ELISA reported a ROC of 0.949 with a sensitivity and specificity of 91.8% and 97.5% respectively 27 . The nonsulfated glycosaminoglycan hyaluronic acid (HA) quantified by ELISA reported a sensitivity and specificity of 88% and 82% increasing to 90% and 84% respectively when combined with hyaluronidase, a catalytic enzyme that degrades HA 21 .…”