Enzyme-linked immunoadsorbent assay for serum IgE: evaluation in four centres.

We report an evaluation of a commercially available kit, the Biomérieux IgE-kit, for determination of total IgE in serum by the EIA double antibody sandwich method. Results by this procedure and PRIST (Pharmacia) show a degree of association (r) of 0.98 and a regression equation of log Y = 0.79 log PRIST + log 3.31. Correlation between the IgE kit and RIST shows a degree of association of 1.00 and a regression equation of log Y = 1.01 log RIST--log 1.05. Between-laboratory standard deviations are 3%, 3%, and 15% for the IgE concentrations of, respectively, 83, 285, and 900 IU/ml. Similarly, intra- and inter-assay correlations were performed on 60 lyophilised serum samples tested in the four centres. No protein interference was found except for cryoprecipitates. The favourable correlation with existing procedures and the feasibility of this kit offer a new way of measuring IgE levels.