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A comprehensive comparison between ISAC and ALEX2 multiplex test systems.

Anouk C M Platteel1, Pieter van der Pol1, Jean-Luc Murk1

  • 1Microvida Laboratory of Medical Microbiology and Immunology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Noord-Brabant, Netherlands.

Clinical Chemistry and Laboratory Medicine
|April 26, 2022
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Summary

The ALEX 2 multiplex assay shows high agreement with the ImmunoCAP ISAC system for diagnosing type I hypersensitivity. This allergy testing platform offers reliable results for specific IgE antibody detection.

Keywords:
ALEX2ISACallergic diseasemolecular allergy diagnosticsmultiplex allergy array

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Area of Science:

  • Allergy and Immunology
  • Diagnostic Testing
  • Molecular Diagnostics

Background:

  • Type I hypersensitivity diagnosis relies on clinical history, provocation tests, and immunological assays.
  • Multiplex specific IgE (sIgE) testing allows simultaneous detection of sIgE antibodies against numerous allergens.
  • Evaluating novel diagnostic platforms is crucial for improving allergy diagnostics.

Purpose of the Study:

  • To assess the performance of the ALEX 2 multiplex platform for allergy diagnostics.
  • To compare the ALEX 2 test results with the established ImmunoCAP ISAC system.
  • To determine the concordance and agreement metrics between the two sIgE testing platforms.

Main Methods:

  • Serum samples from 49 patients with known ISAC results were analyzed using the ALEX 2 platform.
  • Comparison involved 103 common allergen components present on both platforms.
  • Statistical analysis included Cohen's kappa, negative percent agreement (NPA), and positive percent agreement (PPA).

Main Results:

  • Overall agreement between ALEX 2 and ISAC was high at 94%.
  • Negative percent agreement (NPA) was 95%, and positive percent agreement (PPA) was 90%.
  • Kappa values ranged from 0.60 to 0.92, indicating moderate to almost perfect agreement; 59% of discrepancies involved weak positive results.

Conclusions:

  • The ALEX 2 multiplex assay demonstrates high concordance with the ImmunoCAP ISAC system for common allergen components.
  • The findings support the reliability of the ALEX 2 platform for sIgE testing in allergy diagnostics.
  • Further investigation into discrepancies, particularly weak positive results, may refine clinical interpretation.