Cytokeratin Shedding in Urine as a Biological Marker for Bladder Cancer: Monoclonal Antibody‐Based Evaluation

Abstract

Cytokeratin shedding into urine was measured using a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) in 282 individuals. Samples included urine from normal controls, patients with urogenital conditions and bladder cancer patients. A monoclonal antibody prepared against cytokeratins extracted from a hyperkeratotic low grade squamous cell carcinoma (UNME/K1) was used in the assay. The results indicated reasonable levels of sensitivity (83%), specificity (67%) and overall accuracy (70%) in the detection of bladder cancer. The levels of sensitivity in detecting squamous and transitional cell carcinoma patients were 87 and 73% respectively. The low level of specificity was due to a high frequency of false positive results (55%) within the urogenital controls; this suggests that further immunochemical and immunohistopathological analyses of associated urothelial cytokeratins are required.

Bladder tumor markers: from hematuria to molecular diagnostics – where do we stand?

“…Some, such as 8, 18, 19 and 20, have been investigated as tumor markers in bladder cancer after authors had noted increased gene expression in malignant urothelial cells compared with normal cells [67]. Two assays exist based upon cytokeratins 8 and 18: the UBC-Rapid and UBC-ELISA tests.…”