Role of NMP22 bladder chek test in early detection of bladder cancer.

Objectives: To assess clinical performance of NMP22 Bladder Chek Test and to compare it with voided urine cytology and cystoscopy in early detection of Bladder Cancer. Study Design & Settings: Prospective, double blind, hospital based study. Material & Methods: A total of 115 patients were enrolled in this study, 96 patients were follow up cases of Bladder Cancer and 19 were new cases suspected on clinical grounds. Urine samples were assayed for the presence of NMP22 using NMP22 Bladder Chek Test and Cytology was performed by a cyto-pathologist. The diagnosis, determined from the Cystoscopic findings and biopsy findings of the suspicious lesion was considered as the gold standard. For positive biopsies, the results of the NMP22 Test and cytology were also correlated with tumor grade and stage. Results: Mean age of the patients was 57.2 years for males and 55.3 years for females. Most of the patients in our study were asymptomatic (48.7%) as they were follow up cases of Bladder Cancer. Second most common presenting symptom was Hematuria (46.1%) followed by Dysuria (21.7%) and Urgency (7.8%). A total of 39 cases of Bladder Cancer (TCC) were diagnosed among which NMP22 test was positive in 28 cases and cytology in 6 cases. The sensitivity of NMP22 Test was 71.8% which was significantly greater then that of cytology (15.4%). The specificities of the NMP22 Test and cytology were 100% and 96.1% respectively. In non-invasive lesions of Bladder Cancer (TCC), NMP22 Test and Cytology was positive in 71.4% and 17.1% of cases respectively. In muscle-invasive lesions, NMP22 Test was positive in 75% and no case was positive for cytology. Conclusions: NMP22 Bladder Chek Test is an easily available and cheap in vitro qualitative test for early detection of Bladder cancer and can be performed in office setting. Further, NMP22 Test is superior to cytology for all grades and stages in detection of recurrence in patients with history of superficial Bladder Cancer. Our study further indicated that NMP22 can be used as a substitute for urine cytology in detection of Bladder Cancer. However, it cannot replace Cystoscopy, but can be used as an adjunct to cystoscopy in the surveillance protocol for patients with Superficial Bladder Cancer