Laboratory-based allergy testing historically has had its limitations, but new modalities are changing the diagnostic landscape of immunoglobulin E (IgE)-associated disorders. The scientific session (34217) Advances in Allergen Testing Diagnostics, at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago will highlight these developments.

IgE antibody detection by Food and Drug Administration (FDA)-cleared serological methods indicates an individual is “sensitized” or IgE antibody positive. However, it does not confirm the presence of an atopic state or allergy, as there are certain conditions in which a patient can have IgE antibody and exhibit no symptoms, session presenter Robert Hamilton, PhD, director of the Johns Hopkins University dermatology, allergy, and clinical immunology reference laboratory, explained.

In some instances, a person who is IgE anti-peanut positive may still be able to eat peanuts without allergic symptoms. The bottom line is IgE antibody is necessary but not sufficient to make the diagnosis of human allergic disease (without a positive clinical history of allergic symptoms temporally associated with an allergen exposure), Hamilton said. He plans to discuss how microarrays and component allergen reagents are being applied in diagnostic allergy testing. “There are advantages and disadvantages of the microarray, which I will discuss in detail,” Hamilton said.

Antonella Cianferoni, MD, PhD, an attending physician in the allergy section at Children’s Hospital of Philadelphia, will cover non-IgE- mediated allergen testing in food allergy. Non-IgE mediated food allergies remain challenging in diagnosing and recognizing allergen triggers, Cianferoni told CLN Stat. “The most frequent non-IgE -mediated type 2 helper T cell (Th2) food allergies are eosinophilic esophagitis (EoE) and food protein-induced enterocolitis (FPIEs).” These diseases, nearly unheard of before the 1990s, have become much more prevalent over the last two decades, according to Cianferoni.

The incidence of EoE has become quite similar to Crohn’s disease, said Cianferoni. As no viable biomarker exists, diagnosis of this condition is based mostly on clinical recognition and pathology, Cianferoni said. “Food allergen triggers are recognized largely by history and empiric dietary changes,” she said.

Research is underway to better understand the pathogenesis of these elusive diseases so that biomarkers for recognizing and monitoring them eventually will be identified. Research also is underway to develop reliable in vitro testing for allergen recognition. “Research is more advanced in EoE than FPIEs,” she said. The fact that FPIEs is often a transient disease that affects infants makes it more challenging to do in-depth research. “Personalized medicine remains a future goal,” Cianferoni said.

A third presenter, Anthony Horner, MD, associate medical director, immunology at Quest Diagnostics, will address technological advances in allergen-specific IGE antibody testing.

According to Hamilton, session participants will learn about:

  • FDA-cleared serological methods available in the United States and their performance characteristics;
  • How serological (laboratory) methods fit into the diagnostic algorithm for human allergic disease; and
  • Utility of component allergen reagents and microarrays, which will remain primary research tools rather than replace singleplex FDA-cleared serological assay methods.

There’s still time to register for the 70th AACC Annual Scientific Meeting & Clinical Lab Expo July 29–August 2 in Chicago. Attend this scientific session on August 1 from 2:30 p.m. to 5 p.m. and earn 2.5 CE hours.