RESUMEN
Objective To develop a competitive immunoassay for quantitative determination of total immunoglobin E (tIgE) in human serum based on light-initiated chemiluminescent assay (LICA).Methods The LICA-tIgE assay was performed by incubating serum samples or calibrator with anti-human IgE antibody-coated chemiluminescet beads,biotinylated human IgE and streptavidin-coated sensitizer beads.The working conditions of this assay were optimized,analytical performance was detected and the correlation of tIgE results between LICA and Beckman Coulter IMMAGE 800 was evaluated.Results The precision of intra-assay and inter-assay (coefficient of variation) ranged from 5.50％ to 7.73％ and 6.45％ to 9.90％,respectively.The functional sensitivity of this assay was 12.65 IU/mL.The recovery rates measured by adding IgE calibrators to human sera with different IgE concentrations were ranged from 104.15％ to 109.37％.The disturbing rates measured by adding total bilirubin,hemoglobin and triacylglycerol to human sera with different IgE concentrations were ranged from-4.49％ to 8.46％.Also,the tIgE results of 111 patients measured by LICA correlated well with those by Beckman Coulter IMMAGE 800 (r2 =0.959).Conclusion LICA developed in this study for detecting tIgE of human serum showed effective perfomance and could meet the basic requirements of clinical diagnostic reagents.