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
Abstract
:1. Introduction
2. Results
3. Discussion
4. Materials and Methods
4.1. Patients
4.2. Procedure
4.3. Statistical Analysis
4.4. Ethics
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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NMI-LG | NMI-HG | MI-HG | NED | Control | p-Value | |
---|---|---|---|---|---|---|
n | 134 | 48 | 60 | 62 | 226 | |
Age Mean (SD) Median Range | 71.0 (11.9) 73.5 26–92 | 73.8 (10.6) 75 51–94 | 73.6 (10.0) 74.5 52–98 | 70.8 (11.4) 72 46–88 | 68.9 (12.2) 71 31–93 | 0.036 |
Sex Female (%) Male (%) | 34 (25.4) 100 (74.6) | 6 (12.5) 42 (87.5) | 19 (31.7) 41 (68.3) | 10 (16.1) 52 (83.9) | 70 (31.0) 156 (69.0) | 0.021 |
Diabetes | 25 (18.7%) | 8 (16.7%) | 12 (20%) | 10(16.1%) | 34 (15%) | 0.849 |
Erythrocyte (urine dipstick) | 83 (61.9%) | 44 (91.7%) | 58 (96.7%) | 38 (61.3%) | 73 (32.3%) | <0.001 |
Leucocytes (urine dipstick) Mean (SD) Median Range | 84.6 (172.6) 0 0–500 | 109.9 (167.6) 25 0–500 | 229.7 (228.1) 100 0–500 | 127.8 (206.6) 20 0–500 | 64.3 (150.3) 0 0–500 | <0.001 |
Nitrite pos. | 5 (3.7%) | 5 (10.4%) | 8 (13.3%) | 3 (4.8%) | 12 (5.3%) | 0.085 |
Cystoscopy | 100 (74.6%) | 33 (68.8%) | 42 (70%) | 49 (79%) | 36 (15.9%) | <0.001 |
UBC (µg/L) Mean (SD) Median Range | 30.9 (63.4) 6.4 5–300 | 95.5 (104.6) 46 5–300 | 66.9 (90.1) 24.85 5–300 | 10 (9.79) 5 5–56.5 | 7.7 (13.92) 5 5–166 | <0.001 |
Sensitivity Specificity PPV NPV | 38.8% 93.8% 78.8% 72.1% | 75.0% 93.8% 72.0% 94.6% | 68.3% 93.8% 74.6% 94.6% | 22.6% 93.8% 50% 81.5% |
NMI-LG | NMI-HG | MI-HG | NED | Control | p-Value | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Center 1 | Center 2 | Center 1 | Center 2 | Center 1 | Center 2 | Center 1 | Center 2 | Center 1 | Center 2 | Center 1 | Center 2 | |
n | 78 | 56 | 26 | 22 | 25 | 35 | 30 | 32 | 78 | 148 | ||
Age Mean (SD) Median Range | 71.1 (11.6) 74 33–90 | 70.8 (12.4) 72 26–92 | 74.9 (11.6) 78.5 52–94 | 72.5 (9.4) 75 51–92 | 74.2 (11.0) 75 52–98 | 73.2 (9.3) 74 53–88 | 73.0 (8.8) 73.5 46–88 | 68.8 (13.1) 70.5 46–88 | 67.6 (12.64) 69.5 31–86 | 69.6 (11.94) 71.5 33–93 | 0.042 | 0.554 |
Gender Female (%) Male (%) | 20 (25.6) 58 (74.4) | 14 (25.0) 42 (75.0) | 4 (15.4) 22 (84.6) | 2 (9.1) 20 (90.9) | 6 (24.0) 19 (76.0) | 13 (37.1) 22 (62.9) | 3 (10.0) 27 (90.0) | 7 (21.9) 25 (78) | 23 (29.5) 55 (70.5) | 47 (31.8) 101 (68.2) | 0.220 | 0.127 |
Diabetes | 22 (28.2%) | 3 (5.4%) | 6 (23.1) | 2 (9.1%) | 6 (24%) | 6 (17.1%) | 5 (16.7%) | 5 (15.6%) | 13 (16.7%) | 21 (14.2%) | 0.469 | 0.337 |
Erythrocyte pos. | 45 (57.7%) | 38 (67.9%) | 24 (92.3%) | 20 (91.0%) | 24 (96.0%) | 34 (97.1%) | 17 (56.7%) | 21 (65.6%) | 34 (43.6%) | 39 (26.4%) | <0.001 | <0.001 |
Leucocytes Mean (SD) Median Range | 79.17 (165.2) 0 0–500 | 92.39 (183.8) 0 0–500 | 142.3 (182.04) 100 0–500 | 71.6 (143.4) 25 0–500 | 249.0 (229.41) 100 0–500 | 215.4 (229.5) 100 0–500 | 142.50 (220.1) 25 0–500 | 113.55 (195.2) 0 0–500 | 76.6 (165.60) 0 0–500 | 57.7 (141.68) 0 0–500 | <0.001 | <0.001 |
Nitrite pos. | 3 (3.8%) | 2 (3.6%) | 4 (5.1%) | 1 (1.8%) | 2 (8%) | 6 (17.1%) | 1 (3.3%) | 2 (6.3%) | 3 (3.8%) | 9 (6.1%) | 0.199 | 0.185 |
Cystoscopy | 47 (60.3%) | 53 (94.6%) | 11 (42.3%) | 22 (100%) | 11 (44%) | 31 (88.6%) | 20 (66.7%) | 29 (90.6%) | 16 (20.5%) | 20 (13.5%) | <0.001 | <0.001 |
UBC [µg/L] Mean (SD) Median Range | 21.1 (43.7) 6.5 5–300 | 44.6 (81.9) 6.2 5–300 | 83.9 (94.8) 41.4 5–300 | 109.3 (115.8) 59.4 5–300 | 61.4 (80.9) 28.9 5–300 | 70.9 (97.1) 20.7 5–300 | 7.48 (7.06) 5 5–39.1 | 12.37 (11.4) 6.5 5–56.5 | 7.8 (13.9) 5 5–121 | 7.6 (14.0) 5 5–166 | <0.001 | <0.001 |
Sensitivity Specificity PPV NPV | 38.5% 92.3% 83.3% 60.0% | 39.3% 94.6% 73.3% 80.5% | 73.1% 92.3% 76.0% 91.1% | 77.3% 94.6% 68.0% 96.6% | 68.0% 92.3% 73.9% 90.0% | 68.6% 94.6% 75.0% 92.7% | 6.7% 92.3% 25% 72% | 37.5% 94.6% 60% 87.5% |
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Ecke, T.H.; Weiß, S.; Stephan, C.; Hallmann, S.; Arndt, C.; Barski, D.; Otto, T.; Gerullis, H. 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. Int. J. Mol. Sci. 2018, 19, 3841. https://doi.org/10.3390/ijms19123841
Ecke TH, Weiß S, Stephan C, Hallmann S, Arndt C, Barski D, Otto T, Gerullis H. 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. International Journal of Molecular Sciences. 2018; 19(12):3841. https://doi.org/10.3390/ijms19123841
Chicago/Turabian StyleEcke, Thorsten H., Sarah Weiß, Carsten Stephan, Steffen Hallmann, Christian Arndt, Dimitri Barski, Thomas Otto, and Holger Gerullis. 2018. "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" International Journal of Molecular Sciences 19, no. 12: 3841. https://doi.org/10.3390/ijms19123841