Evaluation of the NMP22 test and comparison with voided urine cytology in the detection of bladder cancer.

The purpose of this study was to assess the clinical performance of the NMP22 test and to compare it with that of voided urine cytology for the detection of bladder cancer. The NMP22 test was evaluated in two groups of patients. The first group was comprised of patients with histologically confirmed active transitional cell carcinoma (TCC) of the bladder, and the second group contained those with a history of bladder TCC but that were considered to have no evidence of disease on the basis of cystoscopic evaluation of bladder and/or biopsy. Sensitivity was determined in voided urine samples from patients with active TCC of the bladder. Specificity was determined in the urine samples of patients with a history of bladder TCC but no current evidence of disease. The NMP22 test was positive in 53 of 70 samples from patients with active bladder TCC. The sensitivity of the NMP22 test (75.7%) is significantly better than that of voided urine cytology (55.7%). The specificity of the NMP22 test and of voided urine cytology were 72.2% and 88.9% respectively, in patients with a history of bladder TCC but no current evidence of disease. There was no significant difference between the specificity of NMP22 and that of urine cytology. The NMP22 test is superior to voided urine cytology in the detection of TCC of the bladder. The results of this study indicate that the NMP22 test is an useful adjunct to cystoscopy in the detection and monitoring of TCC of the bladder.