Abstract
Allergic diseases are among the most common chronic conditions in the pediatric population. Allergy diagnostic testing is an important part of the evaluation/management of allergic patients because the history may not be precise enough to identify the specific allergen sensitivity. In addition to providing information about specific sensitivities, allergy diagnostic tests have some predictive value in terms of future risk of developing an allergic condition and the severity/persistence of the allergic disease. The two most commonly used methods of confirming allergen sensitization are skin testing and measurement of serum-specific IgE. Both methods have similar diagnostic value in terms of sensitivity and specificity, with both parameters varying with the clinical scenario and allergen tested. Currently, there are three US Food and Drug Administration-cleared, serum-specific IgE assays used in the United States. The three assays report comparable analytic sensitivity, with the coefficients of variation of the precision, reproducibility, and linearity being less than 15%. However, comparative studies have demonstrated significant inter-assay variability, suggesting that they detect different populations of IgE antibody in human sera or do not measure the same antibodies with the same efficiency. Current specific IgE assays utilize allergen extract reagents. Testing with these reagents may identify sensitivity to clinically irrelevant allergens. This diagnostic limitation has spurred the development of molecular diagnostic tests, also referred to as component-resolved diagnostics, which utilize purified native or recombinant allergens to detect IgE sensitivity to individual allergen molecules. These advancements in serum IgE testing may enhance the precision of allergy diagnostic testing, which may decrease the need for oral food challenges and improve the specificity of allergen immunotherapy.
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