The Diagnostic Efficacy And Interference Factors Of NMP22 In Urothelial Carcinoma

Objective To study the diagnostic efficacy of the NMP22 Bladder Chek® test and determine the interference on results of test in the detection of urothelial carcinoma.Methods We evaluated 337 voided urinary specimens of patients with suspicion of urothelial carcinoma. All voided urine samples were evaluated by the Bladder Chek® test, the results were divided into groups by age, anatomical region, stage, grade and compared to the sensitivity of different groups. non-conditional Logistic regression was used to analyze the interference factors on the results of NMP22.Results The total sensitivity and specificity of the NMP22 were 37.0% and 75.4% respectively. The false positive rate and false negative rate were 24.6% and 63.0% respectively. The positive predictive value and negative predictive value were 57.1% and 56.9% respectively. The study showed that the positive rate of the NMP22 increased with the age. The sensitivity between upper and lower urinary tract was not statistically significant(P>0.05). The sensitivity of NMP22 in papillary urothelial neoplasms, papillary urothelial neoplasms of low malignant potential, low grade and high grade urothelial carcinoma were 5.9%, 18.8%, 28.6%, 58.4% respectively. The sensitivity of NMP22 in non-invasive group and invasive group were 23.7% and 55.1% respectively. Pathology, hematuria and urinary tract infection impacted the results of NMP22 test.Conclusion The total sensitivity and specificity of NMP22 were not high enough to replace the endoscopy and biopsy, but the specificity of NMP22 was 94% after excluding the interference factors such as hematuria and infection. In low grade group, NMP22 was better than cytology in sensitivity. The diagnostic efficacy of NMP22 in high grade or high stage group was higher than low grade or low stage group. Also, NMP22 could be used in urothelial carcinoma of upper urinary tract.