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

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

Biomarker Research, October 2017

29046806

Masatoshi Nakagawa, Takashi Karashima, Masayuki Kamada, Eisaku Yoshida, Toru Yoshimura, Masanori Nojima, Keiji Inoue, Taro Shuin, Motoharu Seiki, Naohiko Koshikawa

Monomeric laminin-γ2 in urine is a potential biomarker for bladder cancer. However, the current detection system uses an antibody that cannot discriminate between monomeric laminin-γ2 and the heterotrimeric γ2 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-γ2. 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-γ2 values in the urine were measured using a fully automated chemiluminescence immunoassay. The results revealed that laminin-γ2 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 non-muscle invasive bladder cancer (≤pT1), had higher laminin-γ2 values than patients with benign urological disease or healthy donors. These results suggest that urine monomeric laminin-γ2 may be a promising biomarker to diagnose cases of non-muscle invasive bladder cancer using a fully automated chemiluminescence immunoassay system.