An ultra-sensitive enzyme-enhanced chemiluminescence immunoassay

Objective To establish an ultra-sensitive chemiluminescence immunoassay system for clinical diagnosis. Methods By utilizing alkaline phosphatase as the label and optimized substrate formulation, the sensitivity of chemiluminescence immunoassay has been greatly enhanced. Feasibility has been demonstrated with several assays of clinical utility. Results The signal-to-noise ratio was significantly increased by optimization of AMPPD substrate formulation; TSH, TPSA, cTnI, and HIV p24 were selected to demonstrate the feasibility of high specificity and low detection limit. Conclusions The enzyme-enhanced chemiluminescence immunoassay technology developed by Mindray guarantees high sensitivity and good correlation in clinical performance evaluation, making it a reality to detect multiple clinical analytes on a single integrated platform. Key words: Limit of Detection; Specificity; Ultra-sensitive Chemiluminescence Immunoassay; Alkaline Phosphatase; AMPPD