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ImmunoCAP Specific IgE alpha-Gal Allergen Component Test

The U.S. Food & Drug Administration (FDA) approved the ImmunoCAP Specific IgE alpha-Gal Allergen Component test on July 23, 2020. This in vitro diagnostic tool will assist healthcare professionals in determining patient sensitization to the alpha-Gal carbohydrate in mammalian (red) meat, a potential trigger for anaphylactic reactions.

Alpha-Gal Syndrome (AGS) causes severe reactions in individuals when they consume mammalian meat. Unlike traditional food allergies, symptoms can manifest 3-8 hours after consumption. These reactions vary from itching and hives to severe anaphylaxis. Notably, even long-time meat eaters can develop AGS, with experts suggesting that the sensitization might arise from a lone star tick bite.

Dr. Thomas Platts-Mills of the University of Virginia School of Medicine highlighted the distinct nature of this allergy, emphasizing the challenges in diagnosis due to the delayed reactions. He stressed the importance of precise diagnosis for managing AGS.

The ImmunoCAP Specific IgE blood test, with a wide usage history and over 6,000 references in peer-reviewed publications, identifies allergic sensitizations to various allergens. Its recent adaptations include tests for stinging insect allergies. These tests are available for all patient profiles and are unaffected by factors like current medications, skin conditions, or pregnancy.

Dr. Lakiea Wright of Thermo Fisher Scientific underscored the challenges of diagnosing AGS using traditional skin prick tests due to often inconclusive results. In contrast, quantifying IgE antibodies to alpha-Gal in blood proves a more reliable diagnostic method.

More details on alpha-Gal allergy testing, symptoms, and diagnosis are available at

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