Objective: To establish biotin-avidin monoclonal antibody capture time-resolved fluorescence immunoassay method (BA Mac TrFIA) for rubella virus IgM class antibodies (RV IgM), and evaluate its performance.Methods: With mouse anti-human μ chain monoclonal antibody (anti-μMcAb) as coating antibody, biotinylated RV recombinant antigen as bridging antigen, and streptavidin-labeled europium as a tracer, we prepared to β-naphthoyl trifluoro acetone solution as enhancer solution of the main ingredients, determined anti-RV IgM antibody, and evaluated its detection limit, repeatability, neg. reference product compliance rate, pos. reference product compliance rate, and reagent thermal stability.Compared with similar methodol., we detected 1 020 cases of samples, and the comparison consistency anal. of experiments is down with Kappa test.Results: This method detected the national detection reference materials L1, L2 and L3, and the results were pos. (S / CO ≥ 1.00), intra-assay coefficient of variation (CV) < 15.00%, the national neg. reference product compliance rate of 10/10, and the national pos. reference product compliance rate of 5/5.The kit of the present method is to place at 37 °C constant temperature for 6 d, the detection performance did not change significantly, and results met Zhuhai Hi-Tech Company reagent result 98.82%, Kappa = 0.96.Conclusion: This method has high sensitivity and specificity, good precision; similar methodol. and test results correlated well to meet the needs of clin. applications.