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

Area of Science:

• Clinical Chemistry
• Immunology
• Diagnostic Assays

Background:

• Accurate measurement of total immunoglobulin E (IgE) is crucial for diagnosing allergic diseases.
• Existing methods for IgE determination have varying degrees of precision and correlation.
• Evaluation of commercially available kits is essential for clinical laboratory practice.

Purpose of the Study:

• To evaluate the performance of the commercially available Biomérieux IgE-kit for total IgE determination in serum.
• To compare the results obtained with the Biomérieux IgE-kit against established methods, specifically PRIST and RIST.
• To assess the reliability and feasibility of the Biomérieux IgE-kit for routine clinical use.

Main Methods:

• Enzyme immunoassay (EIA) double antibody sandwich method was employed.
• Comparison with Pharmacia PRIST (Paper Radioimmunosorbent Test) and RIST (Radioimmunosorbent Test) methods.
• Intra- and inter-assay correlation studies were conducted on lyophilized serum samples across four centers.

Main Results:

• High correlation coefficients were observed between the Biomérieux IgE-kit and PRIST (r=0.98) and RIST (r=1.00).
• Regression analyses demonstrated strong agreement between the methods.
• Low between-laboratory standard deviations (3-15%) indicate good precision across different IgE concentrations.
• No significant protein interference was noted, except for cryoprecipitates.

Conclusions:

• The Biomérieux IgE-kit provides a reliable and feasible method for determining total IgE levels in serum.
• The kit exhibits favorable correlation with established IgE measurement procedures.
• This assay offers a valuable alternative for routine IgE quantification in clinical settings.