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Discrepancies between two total IgE assays and difference in reference intervals in healthy adults
Mai Elzieny1, Gabriel N Maine2, Robin A Carey-Ballough1
1Department of Pathology and Laboratory Medicine, Corewell Health William Beaumont University Hospital, Royal Oak, MI, USA.
Journal of Immunological Methods
|June 15, 2024
Summary
Performance differences were found between Abbott Architect and Siemens Immulite total immunoglobulin (Ig) E assays. Laboratories should verify reference intervals for accurate clinical interpretation of IgE levels.
Area of Science:
- Clinical Chemistry
- Immunology
- Laboratory Medicine
Background:
- Accurate measurement of total immunoglobulin E (IgE) is crucial for diagnosing allergic diseases.
- Different immunoassay platforms may exhibit variations in performance characteristics.
Purpose of the Study:
- To compare the performance characteristics of total IgE assays on the Abbott Architect and Siemens Immulite platforms.
- To determine reference intervals for both test systems in a healthy American adult population.
Main Methods:
- Assessed agreement between Abbott Architect and Siemens Immulite total IgE assays in 331 subjects.
- Established reference intervals using 302 subjects, excluding atopic individuals.
Main Results:
- Siemens Immulite showed a 32% positive bias compared to Abbott Architect for total IgE quantitation.
- The 95th percentile upper limit of the reference interval was higher on the Siemens Immulite (132 IU/mL) versus Abbott Architect (102 IU/mL).
Conclusions:
- Significant quantitative differences exist between FDA-cleared total IgE assays despite calibration with the same WHO reference material.
- Clinical laboratories should validate vendor-provided reference intervals and establish internal ranges for accurate patient results.
