Rapid detection of bladder cancer using a point-of-care nuclear matrix protein 22 BladderChek control kit: a multicenter clinical trial

Abstract

Objective To evaluate the clinical significance of nuclear matrix protein 22 (NMP22) test in rapid diagnosis of bladder cancer.Methods From February 2009 to November 2011,803 patients and 200 healthy individuals were included in this multicenter study from four urology centers in China.They provided a urine sample for test of NMP22 protein using a point-of-care NMP22 BladderChek control kit (colloidal gold method).All tests were evaluated in a blinded fashion.Patients were divided into three groups.Group 1 included 392 patients of bladder cancer; group 2 included 411 patients who had benign urinary disease with non-bladder cancer history or non-bladder cancer; group 3 included 200 healthy individuals.The sensitivity and specificity of NMP22 test were analyzed compared with pathologic results using Pearson Chi-square test.Results The overall sensitivity and specificity of the NMP22 test were 69.6％ (273/392,95％ CI 64.9％-74.0％) and 84.9％ (519/611,95％CI 81.1％-87.6％),respectively.In group 1,337 patients had pathologic stage data,and the sensitivities of the NMP22 test for each stage were Ta-T1 69.6％ (165/237) and T2-T4 82.0％ (82/100),respectively; 322 patients had pathologic grade data,and the sensitivities for each grade were G1 60.5％ (72/119),G2 66.2％ (47/71) and G3 90.9％ (120/132),respectively.The specificities for patients of benign urinary disease,of non-bladder cancer history or nonbladder cancer and healthy individuals were 87.8％ (324/369),69.0％ (29/42) and 97.5％ (195/200),respectively.Conclusion NMP22 BladderChek control kit had high sensitivity and specificity in detection of bladder cancer,and it can be used in early detection and rapid diagnosis of bladder cancer. Key words: Nuclear matrix-associated proteins; Urinary bladder neoplasms; Diagnosis; Reagent kits, diagnostic; Multicenter studies