Thermo Fisher Scientific Inc, Waltham, Mass, recently received FDA premarket notification (510(k)) clearance for five new ImmunoCap allergen component tests for detecting immunoglobulin E (IgE) sensitization to hazelnut, walnut, and cashew nut proteins. The tests are performed on the company’s Phadia laboratory systems.

ImmunoCap allergen component tests measure a patient’s IgE antibody sensitization to individual tree nut proteins called allergen components. Quantifying a patient’s IgE sensitization to these allergen components can help clinicians identify primary nut sensitization, and differentiate it from sensitization due to crossreactivity. Proper diagnoses can help clinicians develop more comprehensive management plans. The newly FDA-cleared tests include:

  • ImmunoCap allergen f439, allergen component rCor a 14 (hazelnut), and ImmunoCap allergen f440, allergen component nCor a 9 (hazelnut). IgE antibodies to hazelnut storage proteins Cor a 9 and Cor a 14 are suggestive of primary hazelnut allergic sensitization.
  • ImmunoCap allergen f441, allergen component rJug r 1 (walnut), and ImmunoCap allergen f442, allergen component rJug r 3 (walnut, lipid transfer protein). IgE antibodies to walnut storage protein Jug r 1 are suggestive of a primary walnut allergic sensitization. Antibodies to Jug r 3, a lipid transfer protein (LTP), is suggestive of crossreactivity involving other LTP-containing foods.
  • ImmunoCap allergen f443, allergen component rAna o 3 (cashew), is a storage protein that is highly abundant in cashew nuts and associated with species-specific cashew allergic sensitization.

For more information, visit Thermo Fisher Scientific.