Abstract

Objectives: Measurement of urine fibrin–fibrinogen degradation products has been reported to be a useful marker for bladder malignancies. This is a simple, noninvasive and rapid method in the diagnosis and follow–up of bladder cancer. We performed a prospective study to evaluate the reliability of the Accu–Dx test which detects urinary fibrin and fibrinogen products associated with bladder cancer. Material and Methods: 97 patients were included in this study. 55 patients with bladder cancer were under surveillance, and 35 were evaluated as primary cases. The Accu–Dx test was performed in 7 additional patients presenting with hematuria due to benign disorders. Urine cytology specimens were collected in all, whereas bladder pathology specimens were obtained in 93. The Accu–Dx test was evaluated with regard to the results of urine cytology and pathological assessment, which constituted the gold standard. Results: According to pathology, 69 patients had carcinoma of the bladder. In 48 (69.6%), the Accu–Dx test was positive whereas urine cytology was positive in only 31 (44.9%; p<0.001). Specificity rates were 67.9 and 96.4%, respectively. With higher stages and higher tumor grades, the Accu–Dx test yielded higher positive rates (50% in Ta versus 100% in T2 or higher and 42.9% in G1 versus 94.1% in G3). On the other hand, the test was positive in 6 patients with cystitis of various etiologies. The overall accuracy rate for Accu–Dx was 69%. Conclusions: The Accu–Dx test is a simple, rapid, reproducible and more importantly a noninvasive method in the detection of bladder malignancies. But it seems inadequate to replace conventional cystoscopy plus pathologic assessment due to its relatively low accuracy and specificity rates. It may be helpful in selecting patients who should be evaluated with rigid endoscopes together with bladder biopsies.

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