New Test ANNOUNCEMENT

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1 March 2003 W New Test ANNOUNCEMENT A Mayo Reference Services Publication Pediatric Allergy Screen <3 Years, Serum #83345 Profile Information Clinical Unit Code Reporting Title Available Separately Egg White, IgE Yes Milk, IgE Yes Wheat, IgE Yes Soybean, IgE Yes House Dust Mites/D.F., IgE Yes Clinical manifestations of immediate hypersensitivity (allergic) diseases are caused by the release of proinflammatory mediators (histamine, leukotrienes, and prostaglandins) from immunoglobulin E (IgE)-sensitized effector cells (mast cells and basophils) when cell-bound IgE antibodies interact with allergen. In vitro serum testing for IgE antibodies provides an indication of the immune response to allergen(s) that may be associated with allergic disease. The allergens chosen for testing often depend upon the age of the patient, history of allergen exposure, season of the year, and clinical manifestations. In individuals predisposed to develop allergic disease(s), the sequence of sensitization and clinical manifestations proceed as follows: eczema and respiratory disease (rhinitis and bronchospasm) in infants and children less than 5 years due to food sensitivity (milk, egg, soy, and wheat proteins) followed by respiratory disease (rhinitis and asthma) in older children and adults due to sensitivity to inhalant allergens (dust mite, mold, and pollen inhalants). Useful For Interpretation Testing for IgE antibodies may be useful to establish the diagnosis of an allergic disease and to define the allergens responsible for eliciting signs and symptoms. Testing also may be useful to identify allergens responsible for anaphylaxis, to confirm sensitization to particular allergens prior to beginning immunotherapy, and to investigate the specificity of allergic reactions to insect venom allergens, drugs, or chemical allergens. Detection of IgE antibodies in serum (Class 1 or greater) indicates an increased likelihood of allergic disease as opposed to other etiologies and defines the allergens responsible for eliciting signs and symptoms. The level of IgE antibodies in serum varies directly with the concentration of IgE antibodies expressed as a class score or ku/l. Cautions Testing for IgE antibodies is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists, or in patients in whom the medical management does not depend upon identification of allergen specificity. Some individuals with clinically insignificant sensitivity to allergens may have measurable levels of IgE antibodies in serum, and results must be interpreted in the clinical context. False-positive results for IgE antibodies may occur in patients with markedly elevated serum IgE (>5000 U/mL) due to nonspecific binding to allergen solid phases.

2 Test Title: Pediatric Allergy Screen <3 Years, Serum #83345 Reference Method Homburger HA: Methods in laboratory immunology. In Allergy Principles and Practice. Vol. 1. 5th edition. Edited by E Middleton, Jr, CE Reed, EF Ellis, et al. St Louis, MO, Mosby Year Book Inc, 1998, pp Solid phase, enzyme immunoassay (Package insert: Pharmacia CAP System RAST FEIA, Pharmacia Immunocap system, Rev 3/00) Specimen Required: Draw blood in a plain, red-top tube(s). Spin down and send 1.0 ml of serum refrigerated for each 5 allergens requested. Please designate specific allergens from list in Special Instructions. NOTE: Please complete an Allergen Request Form (Supply T236) and forward it with the specimen. Reference Values: Analytic Time: Days Set Up: Fee: CPT Code: Class IgE ku/l Interpretation 0 <0.35 Negative Equivocal Positive Positive Strongly positive Strongly positive 6 >100.0 Strongly positive 1 day Monday through Saturday $ /x5

3 March 2003 W New Test ANNOUNCEMENT A Mayo Reference Services Publication Pediatric Allergy Screen 3-8 Years, Serum #83346 Profile Information Clinical Unit Code Reporting Title Available Separately Egg White, IgE Yes House Dust Mites/D.F., IgE Yes Timothy Grass, IgE Yes Short Ragweed, IgE Yes Cat Epithelium, IgE Yes Alternaria Tenuis, IgE Yes Clinical manifestations of immediate hypersensitivity (allergic) diseases are caused by the release of proinflammatory mediators (histamine, leukotrienes, and prostaglandins) from immunoglobulin E (IgE)- sensitized effector cells (mast cells and basophils) when cell-bound IgE antibodies interact with allergen. In vitro serum testing for IgE antibodies provides an indication of the immune response to allergen(s) that may be associated with allergic disease. The allergens chosen for testing often depend upon the age of the patient, history of allergen exposure, season of the year, and clinical manifestations. In individuals predisposed to develop allergic disease(s), the sequence of sensitization and clinical manifestations proceed as follows: eczema and respiratory disease (rhinitis and bronchospasm) in infants and children less than 5 years due to food sensitivity (milk, egg, soy, and wheat proteins) followed by respiratory disease (rhinitis and asthma) in older children and adults due to sensitivity to inhalant allergens (dust mite, mold, and pollen inhalants). Useful For Interpretation Testing for IgE antibodies may be useful to establish the diagnosis of an allergic disease and to define the allergens responsible for eliciting signs and symptoms. Testing also may be useful to identify allergens responsible for anaphylaxis, to confirm sensitization to particular allergens prior to beginning immunotherapy, and to investigate the specificity of allergic reactions to insect venom allergens, drugs, or chemical allergens. Detection of IgE antibodies in serum (Class 1 or greater) indicates an increased likelihood of allergic disease as opposed to other etiologies and defines the allergens responsible for eliciting signs and symptoms. The level of IgE antibodies in serum varies directly with the concentration of IgE antibodies expressed as a class score or ku/l. Cautions Testing for IgE antibodies is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists, or in patients in whom the medical management does not depend upon identification of allergen specificity. Some individuals with clinically insignificant sensitivity to allergens may have measurable levels of IgE antibodies in serum, and results must be interpreted in the clinical context. False-positive results for IgE antibodies may occur in patients with markedly elevated serum IgE (>5000 U/mL) due to nonspecific binding to allergen solid phases.

4 Test Title: Pediatric Allergy Screen 3-8 Years, Serum #83346 Reference Method Homburger HA: Methods in laboratory immunology. In Allergy Principles and Practice. Vol. 1. 5th edition. Edited by E Middleton, Jr, CE Reed, EF Ellis, et al. St Louis, MO, Mosby Year Book Inc, 1998, pp Solid phase, enzyme immunoassay (Package insert: Pharmacia CAP System RAST FEIA, Pharmacia Immunocap system, Rev 3/00) Specimen Required: Draw blood in a plain, red-top tube(s). Spin down and send 1.0 ml of serum refrigerated for each 5 allergens requested. Please designate specific allergens from list in Special Instructions. NOTE: Please complete an Allergen Request Form (Supply T236) and forward it with the specimen. Reference Values: Analytic Time: Days Set Up: Fee: CPT Code: Class IgE ku/l Interpretation 0 <0.35 Negative Equivocal Positive Positive Strongly positive Strongly positive 6 >100.0 Strongly positive 1 day Monday through Saturday $ /x6

5 March 2003 W New Test ANNOUNCEMENT A Mayo Reference Services Publication Pediatric Allergy Screen >8 Years, Serum #83347 Profile Information Clinical Unit Code Reporting Title Available Separately House Dust Mites/D.F., IgE Yes Short Ragweed, IgE Yes Timothy Grass, IgE Yes Cat Epithelium, IgE Yes Alternaria Tenuis, IgE Yes Clinical manifestations of immediate hypersensitivity (allergic) diseases are caused by the release of proinflammatory mediators (histamine, leukotrienes, and prostaglandins) from immunoglobulin E (IgE)- sensitized effector cells (mast cells and basophils) when cell-bound IgE antibodies interact with allergen. In vitro serum testing for IgE antibodies provides an indication of the immune response to allergen(s) that may be associated with allergic disease. The allergens chosen for testing often depend upon the age of the patient, history of allergen exposure, season of the year, and clinical manifestations. In individuals predisposed to develop allergic disease(s), the sequence of sensitization and clinical manifestations proceed as follows: eczema and respiratory disease (rhinitis and bronchospasm) in infants and children less than 5 years due to food sensitivity (milk, egg, soy, and wheat proteins) followed by respiratory disease (rhinitis and asthma) in older children and adults due to sensitivity to inhalant allergens (dust mite, mold, and pollen inhalants). Useful For Interpretation Testing for IgE antibodies may be useful to establish the diagnosis of an allergic disease and to define the allergens responsible for eliciting signs and symptoms. Testing also may be useful to identify allergens responsible for anaphylaxis, to confirm sensitization to particular allergens prior to beginning immunotherapy, and to investigate the specificity of allergic reactions to insect venom allergens, drugs, or chemical allergens. Detection of IgE antibodies in serum (Class 1 or greater) indicates an increased likelihood of allergic disease as opposed to other etiologies and defines the allergens responsible for eliciting signs and symptoms. The level of IgE antibodies in serum varies directly with the concentration of IgE antibodies expressed as a class score or ku/l. Cautions Testing for IgE antibodies is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists, or in patients in whom the medical management does not depend upon identification of allergen specificity. Some individuals with clinically insignificant sensitivity to allergens may have measurable levels of IgE antibodies in serum, and results must be interpreted in the clinical context. False-positive results for IgE antibodies may occur in patients with markedly elevated serum IgE (>5000 U/mL) due to nonspecific binding to allergen solid phases.

6 Test Title: Pediatric Allergy Screen >8 Years, Serum #83347 Reference Method Homburger HA: Methods in laboratory immunology. In Allergy Principles and Practice. Vol. 1. 5th edition. Edited by E Middleton, Jr, CE Reed, EF Ellis, et al. St Louis, MO, Mosby Year Book Inc, 1998, pp Solid phase, enzyme immunoassay (Package insert: Pharmacia CAP System RAST FEIA, Pharmacia Immunocap system, Rev 3/00) Specimen Required: Draw blood in a plain, red-top tube(s). Spin down and send 1.0 ml of serum refrigerated for each 5 allergens requested. Please designate specific allergens from list in Special Instructions. NOTE: Please complete an Allergen Request Form (Supply T236) and forward it with the specimen. Reference Values: Analytic Time: Days Set Up: Fee: CPT Code: Class IgE ku/l Interpretation 0 <0.35 Negative Equivocal Positive Positive Strongly positive Strongly positive 6 >100.0 Strongly positive 1 day Monday through Saturday $ /x5

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