This study was undertaken to determine the clinical usefulness of
NMP22 (
Nuclear Matrix Protein 22) as a urinary marker for the surveillance of
bladder cancer, especially in comparison with that of voided urine cytology. Urinary
NMP22 values were determined for 144 patients with histologically diagnosed
bladder cancer, 65 patients with other
urological cancers, and 171 healthy volunteers by use of a UNMP22 Test kit, which is based on an
enzyme-linked
immunosorbent assay. All
bladder cancer patients were evaluated for urinary
NMP22 values and voided urine cytology simultaneously from the same urine samples. Based on the data from the
bladder cancer patients and the healthy volunteers, the cut-off value was set at 12 U/ml. The median urinary
NMP22 value for the
bladder cancer patients was 17.8 U/ml (95% CI: 13.1-29.0). The sensitivities of urinary
NMP22 and voided urine cytology were 61.1% (88/144) and 33.8% (48/144), respectively, a significant difference (p < 0.00001). Multivariate analysis revealed that
tumor size affected the urinary
NMP22 values. The positive rate by
tumor size was 42.3%, 59.1%, and 85.0% for
tumors of < 10 mm, 10-30 mm, and > 30 mm, respectively. Urinary
NMP22 values decreased postoperatively in 82.9% of the patients. The median
NMP22 values for
prostate cancer and
renal cancer were 4.4 U/ml (95% CI: 2.2-6.7) and 6.2 U/ml (95% CI: 3.6-12.5). The positive rates were 24.2% and 31.3%, respectively, both of which were significantly lower than for
bladder cancer. Our multicenter study indicates that urinary
NMP22 test is more sensitive than voided urine cytology test for the surveillance of
bladder cancer.