Abstract:Objective To develop an automated, economical, quantitative, easy to operate and easily obtained sample detection of human epidermal growth factor receptor-2 (HER2).? Methods Chemiluminescence immunoassay was used in vitro to quantitatively detect the content of HER2 protein in serum. One HER2 monoclonal antibody (primary antibody) was coupled to the carboxyl magnetic beads, and another HER2 monoclonal antibody(secondary antibody) was labeled to acridinium ester, to assemble a double antibody sandwich method detection reagent.? Results The detection range of HER2 protein in this research was from 0 to 500 ng/ml, and precision was CV lower than 5%. The limited of detection and quantification were 0.075 and 0.093 ng/ ml, respectively. Linearity range is from 2. 135 to 780. 427 ng/ ml. The anti-interference test of HAMA positive serum test showed no interference to this kit. The accelerated stability experiment showed that the reagents could be stably stored for 1 years.? Conclusions Compared with Her2 protein chemiluminescence reagents sold on the market, the detection in this study has an excellent expression in various analytical performance, which establish a HER2 protein chemiluminescence detection prototype successfully.