Allergen component specific ige measurement with the Immulite™ 2000 system: diagnostic accuracy and intermethod comparison

J Clin Lab Anal. 2015 Mar;29(2):135-41. doi: 10.1002/jcla.21741. Epub 2014 May 5.

Abstract

Background: The identification of the allergenic molecules, associated to the advances in the field of recombinant allergens, led to the development of a new concept in allergy diagnosis called component-resolved diagnosis. The aim of our study was to evaluate the diagnostic accuracy of different allergen components using the full automatic singleplex quantitative platform Immulite™ 2000.

Methods: One hundred ninety-five allergic outpatients (35 to olive pollen, 35 to birch pollen, 35 to profilin, 35 to house dust mites, 35 to peach, and 20 to shrimp) and 20 negative controls were enrolled for the study. Bet v 1, Bet v 2, Ole e 1, Der p 1, Der p 2, Der f 1, Der f 2, Pru p 3, tropomyosin were tested both with Immulite™ 2000 and ImmunoCAP™ (Thermo Fisher Scientific, Uppsala, Sweden).

Results: Sensitivity of allergen-specific Immunoglobulin E (sIgE) to Ole e 1, Bet v 1, Der p 1, Der p 2, Der f 1, Der f 2, Pen m 1, and Pru p 3 with Immulite™ 2000 was 100%, 100%, 77.1%, 94.3%, 71.4%, 94%, 75%, and 97.1%, respectively, and the specificity was 100% for all the allergens. The overall agreement between Immulite™ 2000 and ImmunoCAP™ (Thermo Fisher Scientific) platforms was 98.6% (Cohen's kappa = 0.979; confidence interval [CI] 95%: 0.960-0.997). From moderate to strong, positive linear correlations between the assays (r(2) from 0.322 to 0.860, and Spearman's rho from 0.824 to 0.971) were showed.

Conclusions: A high diagnostic accuracy of the sIgE to allergen components measurement with Immulite™ 2000 and a high agreement with ImmunoCAP™ platforms were shown in this study.

Keywords: Immulite 2000; allergy diagnosis; component resolved diagnosis; molecular allergens.

Publication types

  • Comparative Study

MeSH terms

  • Allergens / analysis
  • Allergens / immunology*
  • Animals
  • Betula / immunology
  • Cross Reactions / immunology
  • Food Hypersensitivity / immunology
  • Humans
  • Hypersensitivity / immunology*
  • Immunoglobulin E / blood*
  • Olea / immunology
  • Pollen / immunology
  • Profilins / immunology
  • Prunus / immunology
  • Pyroglyphidae / immunology
  • Sensitivity and Specificity
  • Shellfish
  • Skin Tests

Substances

  • Allergens
  • Profilins
  • Immunoglobulin E