Performance evaluation of ImmunoCAP® ISAC 112: a multi-site study

Area of Science:

• Allergy diagnostics
• Immunoassay technology
• Molecular allergology

Background:

• Re-introduction of the ImmunoCAP® ISAC 112 multiplex immunoassay.
• Need to evaluate its performance for specific IgE (sIgE) measurements to allergen components.

Purpose of the Study:

• To assess the performance and reproducibility of the ImmunoCAP® ISAC 112 assay across multiple international laboratory sites.
• To validate the reliability of IgE measurements to allergen components using this multiplex platform.

Main Methods:

• Multi-center study conducted at 22 European and 1 South African sites.
• Assays performed using different microarrays batches, positive/negative serum samples, and a calibration sample.
• Standardized procedures followed manufacturer's instructions for IgE measurements.

Main Results:

• Consistent results observed across all 23 sites for both positive and negative samples, with low false positive rates (0.014%).
• High reproducibility demonstrated through homogeneity analysis and clustering of identical samples.
• Good accuracy confirmed by analysis of raw continuous data, with overall study variability estimated at 25.5% after outlier filtering.

Conclusions:

• The ImmunoCAP® ISAC 112 immunoassay exhibits robust and consistent performance across diverse laboratory settings.
• Results are reliable irrespective of assay site, laboratory conditions, instruments, or microarray batches.
• The assay is suitable for accurate IgE measurements to allergen components in multi-site diagnostic applications.