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Updated: Aug 17, 2026
Application of Biochip Microfluidic Technology to Detect Serum Allergen-specific Immunoglobulin E (sIgE)
Published on: April 21, 2019
Performance validation of a third-generation allergen-specific IgE assay in the clinical laboratory: interlaboratory
Thomas M Li1, Paul Fu, Vlasta Zic
1Invitrogen, 1610 Faraday Avenue, Carlsbad, CA 92008, USA. thomas.li@invitrogen.com
Background:
Allergen-specific IgE (sIgE) measurements are used to help identify causative allergenic agents and to determine the degree of sensitization to facilitate treatment decisions. We examined the performance of a new third-generation chemiluminescent enzyme immunoassay for allergen-specific IgE (sIgE) on the continuous random access Immulite 2000 system.
Methods:
Detection limit and dilutional linearity were determined. Within-run and total precision were assessed according to the NCCLS EP5 guideline. Interlaboratory comparison of the new Immulite 2000 third-generation allergen-specific IgE assay was performed, as well as intermethod comparison against the Pharmacia FEIA, a second-generation assay.
Results:
The detection limit was <0.1 kU/l. Dilutional linearity held from 100 down to 0.2 kU/l. Regression analysis of the interlaboratory comparison results yielded: Immulite 2000(Laboratory 1)=1.07 Immulite 2000(Laboratory 2)+0.18 kU/l; r=0.98, n=3588 results. Intermethod comparison showed the following: Immulite 2000=0.83 (Pharmacia FEIA)+0.42 kU/l; r=0.79, n=512 results. Bland-Altman analysis of the interlaboratory and intermethod comparisons indicated no systematic bias.
Conclusions:
We confirmed the reported performance characteristics of the third-generation sIgE assay and found reasonably good interlaboratory and intermethod agreement. The extended range capability of the third-generation assay provides a new tool for investigating cutoffs and trends in childhood allergy disease progression at concentrations <0.35 kU/l.
