[Article in Italian]

P. Bassi¹, R. Carando¹, M. Norcen¹, F. Pagano¹, H. Leyh², M. Marberger³, P. Conort⁴, C. Sternberg⁵, V. Pansadoro⁵, L. Boccon-Gibod⁶

SUMMARY

• To compare sensitivity and specificity of the BTA Statä test with urine cytology in the diagnosis of bladder cancer specimens from 240 patients with or without definitive diagnosis of bladder cancer have been evaluated in a multicenter and prospective study. In 107 patients with cytoscopically confirmed bladder cancer, the overall sensitivities of BTA Stat and cytology were 65% and 33% respectively. For tumor grades 1, 2, and 3 the sensitivities of BTA Stat were 39%, 67%, and 83%, in comparison with a sensitivity of cytology of 4%, 20%, and 69%, respectively. The specificities of the BTA Stat and cytology in the 124 patients without bladder cancer were 64% and 99% respectively. The specificity of BTA Stat was lower in patients with benign or malignant genitourinary diseases other than bladder cancer (46%) than in patients without such diseases (71 %).

In conclusion, BTA Stat is more sensitive than cytology in the detection of bladder cancer; it could replace cytology in the diagnosis and follow-up of patients with bladder cancer. Any cause of false positive diagnosis must be excluded.