Abstract: The study developed a chemiluminescent immunoassay(CLIA) test kit which can detect folic acid in serum quickly and accurately. First of all, the sample treatment agent was used to rapidly release the bounding folate in the serum completely, and then folate was detected with folate binding protein to establish a competition chemiluminescence immunoassay. Through the optimization of each component in the kit, the minimum detection limit of this kit was 1 ng/mL, the linear range was 1.5-50 ng/mL with high specificity, and the intra-assay and inter-assay coefficients of variation were both less than 10%. Its storage duration could be 16 months at 2-8℃. Two hundred clinical serum samples were tested, and the correlation coefficient of the kit test results with the control kit manufacturers (Beckman) was 0.9847. The detection technology innovatied the use of Biotin-Avidin-System to improve the detection accuracy and sensitivity, and developed a new sample processing reagents and methods to make the release of serum folic acid more quickly and completely. All the technical parameters of the folic acid quantification kit are setting the pace in the home market. It can be widely used in the detection of clinical samples.

Key words: serum folic acid, chemiluminescent immunoassay, Biotin-Avidin-System, kit