Initial Evaluation of the Diagnostic Performance of the New Urinary Bladder Cancer Antigen Test as a Tumor Marker for Transitional Cell Carcinoma of the Bladder

Sänchez‐Carbayo, Marta; Herrero, Enrique; Megías, Julián; Mira, Antonio; Espasa, Antonia; Chinchilla, Virtudes Chinchilla; Soria, Federico

doi:10.1016/s0022-5347(01)61604-5

Cited by 44 publications

(5 citation statements)

References 21 publications

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“…Our study showed good performance of qualitative UBC®Rapid in detecting bladder cancer in Asian population. The sensitivity (53%) and specificity (85.5%) in our study are comparable to those reported in Western population (sensitivity ranging from 46.2% to 78.4% and specificity ranging from 82.4% to 97.4%) [ 4 , 7 , 16 , 17 , 18 , 19 , 20 , 21 ]. Thus, UBC®Rapid may be useful in detecting bladder cancer in Asian population.…”

Section: Discussionsupporting

confidence: 86%

UBC®Rapid Is Sensitive in Detecting High-Grade Bladder Urothelial Carcinoma and Carcinoma in situ in Asian Population

2022

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Objectives: Bladder cancer is a common type of malignancy. UBC®Rapid is a novel immunoassay detecting urine cytokeratin 8/18 protein. Studies have shown good accuracy of UBC®Rapid in detecting bladder cancer. UBC®Rapid has however to date not been evaluated in Asian patients. We evaluated UBC®Rapid in detecting Asian bladder cancer, together with urine cytology. Methods: In total, 112 patients were recruited from National University Hospital Singapore and 103 patients were included in this study, comprising 49 patients with bladder urothelial carcinoma (UC), 21 patients with bladder benign lesions, and 33 patients with normal bladder. All the bladder cancer and benign lesions were confirmed by histology. Voided urine was collected for UBC®Rapid test. The results were compared with urine cytology. Results: The bladder UC group had remarkably higher UBC®Rapid value than the control groups. The sensitivity, specificity, positive, and negative predictive value of UBC®Rapid in detecting bladder UC were 53%, 85.5%, 76.5%, and 66.8%, respectively. Those of urine cytology were 40.8%, 96.3%, 90.9%, and 64.2%, respectively. Adding UBC®Rapid to urine cytology increased sensitivity to 57.1% but decreased specificity to 81.8%. UBC®Rapid was sensitive in detecting high-grade bladder UC (61.1%) and carcinoma in situ (CIS) (72.7%), as compared to urine cytology for bladder UC (55.6%) and CIS (54.5%), respectively. Conclusion: UBC®Rapid is sensitive in detecting high-grade bladder UC and CIS in Asian population. It may be useful as an adjunct test to achieve better detection of bladder cancer.

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Section: Discussionsupporting

confidence: 86%

UBC®Rapid Is Sensitive in Detecting High-Grade Bladder Urothelial Carcinoma and Carcinoma in situ in Asian Population

2022

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“…Data presented in newer UBC ® Rapid studies reported a cut-off of 12.3 µg/L, a sensitivity, specificity, PPV, and NPV of 60.7%, 70.1%, 46.8%, and 79.3%, respectively, and with an AUC of 0.68 [9]. According to other previous reported UBC ® Rapid studies in the literature, the sensitivity of the qualitative UBC ® Rapid Test ranged from 46.2% to 78.4%, and its specificity from 82.4% to 97.4% [9,12,16,17,18,19,20]. These data concur with our own results, whereas the sensitivity was low with 38.8% for detecting non-muscle invasive low-grade tumors.…”

Section: Discussionmentioning

confidence: 96%

UBC® Rapid 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

Ecke

Weiss

Stephan

et al. 2018

IJMS

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Objectives: UBC® Rapid Test measures soluble fragments of cytokeratins 8 and 18 in urine. We present results of a multicenter study using an updated version of UBC® Rapid 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® 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® Rapid Test in urine are higher in patients with bladder cancer in comparison to the control group (p < 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 µg/L) was evaluated for the whole patient cohort. The area under the curve of the quantitative UBC® Rapid Test using the optimal threshold obtained by receiver operating characteristics (ROC) analysis was 0.774. Elevated values of UBC® Rapid 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® Rapid 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® Rapid results generated in both study centers in the present multicenter study are very similar and reproducible. Furthermore UBC® Rapid Test is standardized and calibrated and thus independent of used batch of test as well as study site.

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“…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 ].…”

Section: Discussionmentioning

confidence: 99%

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

Gleichenhagen

Arndt

Casjens

et al. 2018

IJMS

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Urine-based biomarkers for non-invasive diagnosis of bladder cancer are urgently needed. No single marker with sufficient sensitivity and specificity has been described so far. Thus, a combination of markers appears to be a promising approach. The aim of this case-control study was to evaluate the performance of an in-house developed enzyme-linked immunosorbent assay (ELISA) for survivin, the UBC® Rapid test, and the combination of both assays. A total of 290 patients were recruited. Due to prior bladder cancer, 46 patients were excluded. Urine samples were available from 111 patients with bladder cancer and 133 clinical controls without urologic diseases. Antibodies generated from recombinant survivin were utilized to develop a sandwich ELISA. The ELISA and the UBC® Rapid test were applied to all urine samples. Receiver operating characteristic (ROC) analysis was used to evaluate marker performance. The survivin ELISA exhibited a sensitivity of 35% with a specificity of 98%. The UBC® Rapid test showed a sensitivity of 56% and a specificity of 96%. Combination of both assays increased the sensitivity to 66% with a specificity of 95%. For high-grade tumors, the combination showed a sensitivity of 82% and a specificity of 95%. The new survivin ELISA and the UBC® Rapid test are both able to detect bladder cancer, especially high-grade tumors. However, the performance of each individual marker is moderate and efforts to improve the survivin assay should be pursued. A combination of both assays confirmed the benefit of using marker panels. The results need further testing in a prospective study and with a high-risk population.

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Initial Evaluation of the Diagnostic Performance of the New Urinary Bladder Cancer Antigen Test as a Tumor Marker for Transitional Cell Carcinoma of the Bladder

Abstract: Urinary bladder cancer antigen might have a role as a potential tumor marker for diagnosing transitional cell carcinoma of the bladder.

Cited by 44 publications

References 21 publications

UBC®Rapid Is Sensitive in Detecting High-Grade Bladder Urothelial Carcinoma and Carcinoma in situ in Asian Population

UBC®Rapid Is Sensitive in Detecting High-Grade Bladder Urothelial Carcinoma and Carcinoma in situ in Asian Population

UBC® Rapid 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

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

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