In vitro allergy testing needs better standardization--test results from different laboratories lack comparability...

Area of Science:

• Clinical immunology
• Allergology
• Diagnostic assay development

Background:

• Specific immunoglobulin E (IgE) testing is a cornerstone in diagnosing allergic diseases.
• Standardized diagnostic parameters are expected to yield consistent results across different detection systems.
• Variability in IgE testing can impact diagnostic accuracy and patient management.

Purpose of the Study:

• To assess the comparability and consistency of specific IgE determinations across multiple laboratories and methods.
• To investigate the influence of different antigens, methods, companies, and laboratories on IgE test results.
• To identify areas for improvement in the standardization of IgE testing.

Main Methods:

• A proficiency testing study involving 40 patient sera.
• Distribution of sera to 23 laboratories over a 2-year period.
• Performance of three IgE determinations per serum using laboratory-specific methods.

Main Results:

• Overall comparability of IgE results was generally good, with rare 'wrong' results.
• Significant variability was observed in sensitivity and specificity across different antigens, methods, companies, and laboratories.
• Current diversity in techniques leads to divergent IgE test results.

Conclusions:

• Enhanced standardization of test reagents and methods by suppliers is essential for harmonizing IgE test results.
• Allergists must be aware of the potential for divergent results due to the variety of IgE determination techniques.
• There is a need for legislative oversight to ensure the quality and reliability of diagnostic tools for IgE determination to prevent misdiagnosis and potential harm.