Abstract: This paper aims to develop a sensitive, rapid and stable method that can be used in clinical detection of human serum amyloid A. We established a sandwich chemiluminescent immunoassay（CLIA） method to detect human serum amyloid A quantity in blood samples, and its performance was evaluated. The correlation of standard curve was higher than 0.99. The linear range was 5-800 ng/mL. The detection limit of the method was 0.5 ng/mL. Within-run and between-run precision were lower than 8% and 10%, respectively. One hundred and fifty clinical samples were collected to evaluate the methodological consistency between the developed method and Siemens Kit, and the linear regression results showed a great correlation with r2 higher than 0.98. 

Key words: human serum amyloid A, chemiluminescent immunoassay, performance evaluation