Sensitivity and specificity of urinary hyaluronic acid and hyaluronidase in detection of bladder transitional cell carcinoma.

PURPOSE To the assess sensitivity and specificity of urinary levels of hyaluronic acid (HA) and hyaluronidase (HAase) as an individual or a combined test to diagnose bladder transitional cell carcinoma (TCC). MATERIALS AND METHODS One hundred and ninety-four urine specimens were collected from individuals between July 2007 and March 2008. The urinary level of hyaluronic acid (HA) was measured by Enzyme-linked immunosorbent assay. Thereafter, the urinary levels of HA and HAase were normalized to urinary creatinine level and expressed as ng/mg and μ/mg. RESULTS Eighty percent of patients with bladder cancer had urinary HA level < 500 ng/mg, and 90% of controls showed HA level < 500 ng/mg (P < .001). The mean urinary levels of HA in controls did not vary significantly (P < .05), whereas they significantly increased (2.5 to 6.5 folds) in all grades of TCC. More than 80% of patients with grades 2 and 3 TCC had urinary HAase level < 10 μ/mg and over 80% of controls showed HAase level < 10 μ/mg (P < .05). Hyaluronidase levels increased in patients with grades 2 and 3 bladder TCC. CONCLUSION Measurement of urinary levels of HA and HAase (with 89% sensitivity and 83% specificity) appears to be a highly accurate and non-invasive method for detecting bladder TCC and evaluating its grade.