The application of EP14-A3 in the evaluation of endogenous antibodies interference in immunoassay reagent / 国际检验医学杂志

ABSTRACT

Objective To improve the deficiencies of current methods ,explore a new way to estimate endogenous antibodies in‐terference in immunoassay reagent .Methods According to EP14‐A3 ,RF samples and normal samples were tested at the same time by reference reagents ,reagent A and B respectively .Reagent A and B were to be evaluated .RF samples′location was compared to 95% CI of Deming regression line based on the normal samples .Results In comparison of reagent A vs .reference reagent ,RF sam‐ples exceeded 95% CI upper limit ,which indicated the anti‐interference ability to RF of reagent A was different from the reference reagent statistically .Meanwhile ,all RF samples tested by reagent B fell in 95% CI ,RF samples interfered reagent B hardly ,which indicated the reagent B had similar anti‐interference performance to RF as reference reagent .Conclusion The method from EP14‐A could intuitively reflect the resistance to endogenous antibodies for newly developed immunoassay reagents .