Comparison of molecular and extract-based allergy diagnostics with multiplex and singleplex analysis

Area of Science:

• Allergy diagnostics
• Immunology
• Molecular biology

Background:

• ImmunoCAP ISAC 112 is a commercial molecular allergy IgE multiplex test.
• Limited comparative data exists for this novel test against extract-based and singleplex molecular IgE tests.

Purpose of the Study:

• To compare results from the ISAC multiplex IgE assay with ImmunoCAP singleplex test outcomes.
• Evaluate the diagnostic performance of a novel multiplex allergy testing approach.

Main Methods:

• Analyzed serum samples from 101 adults with grass pollen allergy.
• Measured specific IgE (sIgE) to 112 allergenic molecules using ISAC and singleplex ImmunoCAP tests.
• Included common allergens like dust mite, cat, dog, milk, egg, hazelnut, celery, Alternaria, and pollens (birch, hazel, mugwort, ragweed).
• Performed statistical analysis using Spearman rank correlation and Clopper-Pearson methods.

Main Results:

• Positive Percent Agreement (PPA) between ISAC and singleplex tests ranged from 60-100%.
• Negative Percent Agreement (NPA) ranged from 78-97% for corresponding allergens.
• Results indicate strong agreement for molecular allergy diagnostics.

Conclusions:

• The ISAC multiplex molecular allergy test demonstrates good correlation with ImmunoCAP singleplex results.
• This supports the clinical utility of the ISAC multiplex test in allergy diagnostics.