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DATA SHOW ACCURACY OF IMMUNOCAP^® IS SUPERIOR TO OTHER SPECIFIC IGE BLOOD TESTS IN THE DIAGNOSIS OF ALLERGIES

PORTAGE, MI, July 17, 2007—Data published in the July issue of the Annals of Allergy, Asthma & Immunology revealed that ImmunoCAP is superior to two other allergy diagnostic blood tests in the detection of quantitative specific IgE levels. Specific IgE is produced in the blood as a result of sensitization to an allergen and increases with exposure to that substance. When measured, these levels are indicative of whether or not an individual is likely to have an allergic reaction.

“This study is particularly important because it is the first of its kind to compare specific IgE results of different technologies to known results,” said Robert Reinhardt, MD, professor of family medicine for Michigan State University College of Human Medicine and U.S. Medical Affairs Director, Phadia US, Inc.

This study intended to evaluate three common diagnostic systems for specific IgE antibody levels using serum samples and antibodies from mice (chimeric). The antibody levels had been previously quantified using other analytical means, and the quantity of IgE was known. The assays used in this study included the ImmunoCAP Specific IgE blood test, Turbo-RAST (HY·TEC^® offered by LabCorp (Laboratory Corporation of America)) and 3gAllergy Universal Module (Siemens’ Immulite^® system). These data revealed considerable differences with the Turbo-RAST and 3gAllergy Universal Module compared with the known results.

This study used the three systems to examine specific IgE levels in 60 samples of peanuts and 20 samples of soy. Mouse-human chimeric IgE antibodies specific for the major birch pollen and for the house dust mite allergen also were included in the study. A qualitative evaluation using a cut-off of 0.35 kUA/l showed discrepancies in the ability to detect specific IgE sensitization.

When quantitative evaluation was performed, the 3gAllergy Universal Module overestimated (nearly four-fold) and the Turbo-RAST assay underestimated (approximately ten-fold) the specific IgE antibody levels for peanut and soy, whereas ImmunoCAP very closely agreed with the known results. Similar results were seen with the mouse-human chimeric IgE antibody samples.

“While the systems present their results in the same apparent units or classes, it by no means signifies that the results are correct or interchangeable,” concluded the study authors.

Allergy symptoms often mimic symptoms caused by other conditions, so proper treatment always depends on an accurate diagnosis. By accurately diagnosing allergies early on, healthcare providers can recommend avoidance strategies, so that patients can minimize their exposure to triggers, which collectively are responsible for pushing them over their allergic threshold and intensifying symptoms. ImmunoCAP was the first allergy test to be cleared by the FDA as a truly quantitative test for pinpointing allergens and allergy blood testing is recognized by the National Institutes of Health for the management of patients with asthma.