Evaluation of an enzyme immunoassay for total IgE on a semi-automated analyser. A multicentre study.
Total serum IgE was measured by a semi-automated enzyme immunoassay on sera from normal and disease groups. Data from this investigation was analyzed in respect of precision, linearity, sensitivity and correlation with other test methods. Using human serum pools having values between 7 and 480 IU/ml, the intra-assay coefficient of variation ranged from 3.3 to 14.6% with an arithmetic mean of 6%. The inter-assay coefficient of variation on commercially supplied control sera ranged from 4.4 to 14.2%. In addition, tests were carried out on serially diluted samples to assess the linearity of the method, and on sera with IgE levels of less than 5 IU/ml in order to assess its sensitivity. It was shown that the technique being assessed was unaffected by the presence of lipid or haemoglobin or by the addition of bilirubin or any one of 46 commonly prescribed drugs each at double its toxic dose. There was good correlation between the semi-automated enzyme immunoassay technique and four other methods used during this study. This technique exhibits excellent specificity, reproducibility and a sensitivity well within clinical demands.