A dipstick, dot-ELISA assay for the rapid and early detection of bladder cancer.

A mouse monoclonal antibody (CK1K10) specific for keratin was developed. Enzyme immunoassays (EIAs) were performed to detect keratin in urine samples using CK1K10 and anti-mouse IgG. A high degree of sensitivity and specificity was obtained in the detection of bladder cancer patients. A fast dot-ELISA was developed in which urine is applied onto nitrocellulose (NC) sheets or dipsticks. Dipsticks coated with urine samples can be stored at room temperature for more than 5 days and at -20 degrees C for more than 3 months without loss of efficiency. A high positive correlation was found between the fast dot-ELISA and other EIAs. The assay does not require sophisticated equipment nor highly trained technical staff and can be performed in less than 30 min. The keratin dot-ELISA could be a reliable screening test for the early detection of bladder cancer.