Quantitative Allergy Blood Test Cleared by FDA

A blood test that measures the amount of IgE circulating in the blood has been cleared by the U.S. Food and Drug Adminsitration (FDA). The test also demonstrates patient sensitivity to specific allergens by reporting the number of kilo-units per liter.

Called Immunocap, the test is being marketed by Pharmacia Diagnostics (Upppsala, Sweden). The company states that this is the first and only allergy test to be accepted by the FDA as a truly quantitative test. Accurate information helps doctors to better manage allergy patients.

Data demonstrate that Immunocap meets several performance criteria, including an international reference calibrator and accuracy and precision data. While allergy testing has traditionally been performed by skin testing, the method carries the risk of serious allergic reaction, is not recommended for young children and the elderly, and is not readily available to nonspecialists.

"Immunocap provides a new benchmark for accuracy and reliability, and allows clinicians to assess an individual's reaction to specific food and environmental allergens, and to tailor treatment strategies appropriately,” said Brock Williams, Ph.D., clinical research professor at Children's Mercy Hospital in Kansas City (MO, USA).




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