FDA Clears First Blood Test for Identifying a Novel Allergic
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ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use.

Test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess his or her risk for an anaphylactic reaction.

Researchers believe that sensitization to alpha-Gal may be the result of a bite from the lone star tick (Amblyomma americanum).

According to the American Academy of Asthma, Allergy and Immunology, an allergy to alpha-Gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1, 3-galactose that is found in red meat.

Symptoms range from hives and itching to abdominal pain, nausea or vomiting. In severe cases, the allergy can cause anaphylaxis which can be potentially fatal.

ImmunoCAP Specific IgE blood testing is the most widely used specific IgE blood test and can help identify allergic sensitization to common environmental allergens.

This test was recently cleared by the FDA to help improve the diagnosis of bee and wasp allergies.

Source: https://thermofisher.mediaroom.com/2020-07-23-FDA-Clears-First-Blood-Test-for-Identifying-a-Novel-Allergic-Sensitization-to-Red-Meat
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