Singleplex allergy diagnostic assays: Are they comparable?
About this session
In diagnostic allergy laboratories worldwide, two fully automated, rigorously quality-controlled immunoassay systems are used to quantify human IgE antibodies. Since our initial comparison in 2010, both systems have incorporated molecular allergens as reagents.
Proficiency program data over 14 years confirms excellent agreement in total IgE measurement between IMMULITE® and ImmunoCAP assays, attributed to a common calibrator.
However, caution is warranted when patients have received omalizumab therapy. While qualitative IgE antibody results align well with allergic disease presence, discrepancies arise in quantitative levels, particularly relevant when using non-confirmed specific IgE cutoffs to predict likelihood of food allergy.
Published predictive risk curves cannot be extrapolated between the two immunoassay systems or different patient populations. Notably, recent studies suggest closer agreement in allergen component-specific IgE results between the two systems, though further validation is required.
Robert G. Hamilton
D(ABMLI), USA
Baltimore, Maryland, USA
Robert G. Hamilton, PhD, D(ABMLI), USA
Dr. Robert G. Hamilton is a professor of medicine and pathology and director of the Dermatology, Allergy and Clinical Immunology Reference Laboratory at the Johns Hopkins University School of Medicine in Baltimore, Maryland, USA.
With expertise in allergy and clinical immunology, he teaches, performs research, and for the past 42 years has directed a federally licensed clinical immunology laboratory that performs diagnostic allergy testing. For the past 15 years, he has served as coordinator for the College of American Pathologists’ Diagnostic Allergy Inter-Laboratory Proficiency Survey, which monitors approximately 150 North American laboratories performing diagnostic allergy testing.
His current research focuses on the assessment of immunogenicity and allergenicity of new and established drugs and vaccines. His work contributes significantly to advancing allergy and immunology knowledge, aiming to improve patient care and management.
