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Validation of a Multiplex Assay for Measuring Specific IgG4.

Sung Ryeol Kim1,2, Kyung Hee Park2,3, Ji Eun Lee4

  • 1Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea.

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|May 30, 2020
PubMed
Summary

The PROTIA™ Specific IgG4® assay demonstrates high consistency with the established ImmunoCAP® method for measuring specific IgG4 (sIgG4) levels. This validation supports its use in allergy diagnostics and immunotherapy monitoring.

Keywords:
Immunoglobulin Gallergensimmunoassay

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Area of Science:

  • Immunology
  • Allergy Diagnostics

Background:

  • Specific IgG4 (sIgG4) levels correlate with immune tolerance during allergen-specific immunotherapy, particularly in food allergies.
  • ImmunoCAP® is a widely used single-allergen assay for sIgG4 measurement.
  • PROTIA™ Specific IgG4® is a novel multiplex assay designed for simultaneous sIgG4 quantification.

Purpose of the Study:

  • To validate the PROTIA™ Specific IgG4® multiplex assay by comparing its performance against the ImmunoCAP® assay.
  • To assess the reliability of PROTIA™ Specific IgG4® for measuring sIgG4 across a range of common allergens.

Main Methods:

  • Serum samples from 519 allergy patients were analyzed using both PROTIA™ Specific IgG4® and ImmunoCAP® assays.
  • sIgG4 levels were measured against nine inhalant allergens and nine food allergens.
  • Assay agreement was evaluated through positivity comparisons, Cohen's kappa analysis, and quantitative correlation.

Main Results:

  • PROTIA™ Specific IgG4® exhibited a 95.6% agreement rate with ImmunoCAP® for overall sIgG4 positivity.
  • Substantial correlations (Cohen's kappa coefficient ≥0.699) were observed for most allergens, with strong quantitative correlations (ρ ≥0.8014).
  • High consistency was confirmed through serial dilution tests, indicating assay reliability.

Conclusions:

  • The PROTIA™ Specific IgG4® assay demonstrates high consistency and reliability when compared to the ImmunoCAP® assay for sIgG4 measurement.
  • This validated multiplex assay is suitable for diverse clinical applications, including monitoring allergen immunotherapy and diagnosing food allergies.