SGTi-Allergy Screen PLUS is an in vitro diagnostic test kit intended for the semi-quantitative determination of specific IgE antibodies and the qualitative detection of total IgE in human serum or plasma. The test aids in the diagnosis of IgE-mediated allergic reactions by assessing the levels of specific IgE and total IgE. It is designed for use in patients exhibiting symptoms of allergic reactions to multiple allergens and is intended for use solely by trained healthcare professionals for diagnostic purposes. The test is designed to be used with compatible instruments.
An allergy is an immune response that triggers a sudden hypersensitivity reaction to specific allergens; the causative agent is known as an allergen. Upon the initial entry of a specific allergen into the body, immunoglobulin E (IgE)—produced via the antigen-antibody response—binds to surface receptors on mast cells. Subsequently, when these IgE-primed cells encounter the same allergen, the mast cells are activated and release histamine and pro-inflammatory cytokines, thereby triggering an allergic hypersensitivity reaction. Common clinical symptoms, which may occur sequentially or concurrently, include atopic dermatitis, asthma, rhinitis, and anaphylaxis. Levels of total IgE and allergen-specific IgE can be measured in tissue fluid or blood; this product is designed to provide simultaneous, semi-quantitative results for multiple allergens in a single test. Test results provide information regarding specific allergens and can assist in the diagnosis and treatment of allergic diseases.


