Development of a fully automated chemiluminescence immunoassay for urine monomeric laminin-γ2 as a promising diagnostic tool of non-muscle invasive bladder cancer

Background: Monomeric laminin-gamma 2 in urine is a potential biomarker for bladder cancer. However, the current detection system uses an antibody that cannot discriminate between monomeric laminin-gamma 2 and the heterotrimeric gamma 2 chain of laminin-332, which may cause false-positive reactions. The present study aimed to develop a fully automated chemiluminescence immunoassay system using a specific monoclonal antibody against monomeric laminin-gamma 2. Methods: In total, 237 urine specimens (84 from patients with bladder cancer, 48 from patients with benign urological disease, and 105 from healthy donors) were collected, and monomeric laminin-gamma 2 values in the urine were measured using a fully automated chemiluminescence immunoassay. Results: The results revealed that laminin-gamma 2 values in patients with benign urological disease were comparable to those of healthy donors and that the chemiluminescence immunoassay's lower limit of detection was 10 pg/mL (approximately 20-fold better than the sandwich enzyme-linked immunosorbent assay's limit of 200 pg/mL). Moreover, the chemiluminescence immunoassay demonstrated that patients with bladder cancer, including nonmuscle invasive bladder cancer (<= pT1), had higher laminin-gamma 2 values than patients with benign urological disease or healthy donors. Conclusions: These results suggest that urine monomeric laminin-gamma 2 may be a promising biomarker to diagnose cases of non-muscle invasive bladder cancer using a fully automated chemiluminescence immunoassay system.