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In-Vitro Allergy Testing

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In-Vitro Allergy Testing Lab Management Guidelines V2.0.2021 In-vitro Allergy Testing MOL.CS.317.X v2.0.2021 Introduction In-vitro testing for allergy is addressed by this guideline. Procedures Addressed The inclusion of any procedure code in this table does not imply that the code is under management or requires prior authorization. Refer to the specific Health Plan's procedure code list for management requirements. Procedure addressed by this guideline Procedure code Allergen specific IgG; quantitative or 86001 semiquantitative, each allergen Allergen specific IgE; quantitative or 86003 semiquantitative, each allergen Allergen specific IgE; qualitative, 86005 multiallergen screen (e.g. disk, sponge, card) Allergen specific IgE; quantitative or 86008 semiquantitative, recombinant or purified component each Immunoassay for analyte other than 83516 infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method Gammaglobulin (immunoglobulin); IgE 82785 Peanut allg spec asmt 64 epi 0165U Peanut allg asmt epi clin rx 0178U What Is Allergy Definition Allergy is defined as an immunologically mediated, hypersensitive response to an agent in a sensitized person.1-7 Mechanistically, there are several different pathways of hypersensitivity. In vitro allergy testing is largely concerned with Type I immediate hypersensitivity reactions mediated ©2021 eviCore healthcare. All Rights Reserved. 1 of 30 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Lab Management Guidelines V2.0.2021 by IgE.8 These reactions usually involve a response to an allergen in a previously sensitized individual that can manifest anywhere from minutes to a few hours. Typical clinical signs and symptoms have been described as follows:8 “Common manifestations of type I hypersensitivity reactions include signs and symptoms that can be:” o “Cutaneous (eg, acute urticaria, angioedema)” o “Respiratory (eg, acute bronchospasm, rhinoconjunctivitis)” o “Cardiovascular (eg, tachycardia, hypotension)” o “Gastrointestinal (eg, vomiting, diarrhea)” o “Generalized (eg, anaphylactic shock)...” Allergy and allergy testing, is commonly divided into 5 categories:1 Allergic contact dermatitis (ACD)6 Stinging insect allergy caused by venoms7 Food allergy5 Inhalant allergy (aeroallergy)2,4 Drug allergy3 There is overlap between the categories and, in general, a patient with one type of allergy is at increased risk of experiencing another. An example of the overlap between categories is latex allergy, where the presentation can be cutaneous (mild contact urticaria), respiratory (asthma, rhinoconjunctivitis) or generalized (anaphylactic shock).9 Cross reactivity between different classes of allergens can result in unique clinical syndromes such as the oral allergy syndrome (OAS), which involves cross-reaction between food allergens and aeroallergens.10 Cross reaction between food allergens and pollen aeroallergens is known as the pollen-food syndrome. It is “a localized IgE-mediated reaction… which causes tingling and itching of the mouth and pharynx. This is typically triggered after consumption of certain fresh fruits and vegetables in pollen-allergic individuals. It is caused by cross reactivity between IgE antibodies to certain pollens with proteins in some fresh fruits and vegetables...”10 Latex-fruit syndrome is another OAS caused by cross-reaction between inhaled latex antigens and some fresh fruits and vegetables.11 Practice parameters published jointly by the American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) describe the diagnosis and management of the 5 types of allergy.1-7 The common themes in these practice parameters are: Allergy Testing ©2021 eviCore healthcare. All Rights Reserved. 2 of 30 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Lab Management Guidelines V2.0.2021 The history and physical are the foundation of diagnosing allergy. For uncomplicated cases, if the history and physical are convincing enough, it is within the standard of care for providers treat the allergy without additional testing. The focus of the diagnostic workup is identifying the allergen responsible for the allergic reaction. Diagnostic testing is an adjunct to the history and physical and diagnostic testing alone without clinical correlation is insufficient to make a diagnosis. This is because sensitization to an allergen, which can produce a positive test, is not the same as disease. In allergic disease, the patient is sensitized and experiences a hypersensitivity reaction after allergen exposure. Challenge testing is the gold standard of diagnosis. Thus, oral food challenges are the gold standard of food allergy testing. Challenges are time consuming, with potential serious side effects including anaphylaxis. Therefore, they must take place in a medical setting with appropriate safeguards. After identifying a causative allergen, the basis of treatment is avoidance of the allergen, immune desensitization, or both. There are two general classes of first-line, high-volume testing methods used in the diagnosis of immediate hypersensitivity allergic disease. These are skin testing and in vitro testing of blood.1,12 Skin tests are generally performed in the office. There are several types, each useful in specific settings. In percutaneous skin testing (or skin prick testing, SPT), a specific allergen is pricked onto the skin with a device, and in intradermal testing the allergen is injected under the skin with a needle. Percutaneous testing is the method of choice for food allergy.5,13,14 In a third type of skin testing, patch testing, contact allergens are incorporated into a gel attached to a fabric backing to form a patch that is applied to the skin. This method has been highly standardized and is the test of choice to confirm ACD.6 In vitro testing of blood is most commonly performed by a clinical laboratory. The two most common blood tests are allergen-specific serum IgE testing (sIgE) and total IgE testing.1,8 The AAAAI/ACAAI practice parameters indicate that skin testing is recommended, and in vitro testing is not for ACD and drug allergy testing.3,6 For stinging insect allergy, inhalant allergy, and food allergy, skin testing is preferred over in vitro testing of blood, but both can be useful.2,5,7 In general, when either skin testing or blood testing is useful, physicians tend to prefer skin testing.12 Blood testing tends to be preferred when there are factors preventing accurate testing of skin, for example as occurs in patients with widespread eczema. Allergy Testing ©2021 eviCore healthcare. All Rights Reserved. 3 of 30 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Lab Management Guidelines V2.0.2021 Test Information Introduction In vitro tests for allergy include immunoglobulin and non-immunoglobulin tests. Total IgE This test is performed by automated immunoassay by one of several FDA-approved methods. The test is an adjunct to allergen specific IgE in selected clinical settings such as in patients with severe eczema.14 There is controversy regarding the clinical utility of this test, which has led to admonitions against routine use.5 Allergen Specific IgE (sIgE) A summary of the fundamentals of in vitro testing of blood for allergen specific IgE has been published by Siles and Hsieh.8 This test is most commonly performed by automated immunoassay, and measures patient serum IgE binding to an extract of a specific allergen (e.g. peanut, sesame seed, honeybee venom, birch pollen), usually by fluorescence-labeled assay. In vitro testing for allergen specific IgE is indicated to help confirm a diagnosis of food allergy, inhalational allergy, allergy from stinging insect venoms, or latex. Depending on the antigen being tested, in vitro testing of blood for allergen specific IgE varies in sensitivity from 60 – 95% and in specificity from 30%- 95%.1,8,15,16 Although allergen specific IgE is usually performed by automated immunoassay, it is less commonly performed by an older multi-allergen dipstick method suitable for doctor’s offices.17,18 The dipstick method tests for a preset panel of multiple allergens even if testing some of the allergens is not supported by the patient history and physical. Another version of allergen specific IgE testing is component testing, also referred to as component-resolved diagnostics (CRD).5,19,20 Kattan and Wang describe the method as follows: “Instead of using crude allergen extracts consisting of a mixture of allergenic and non-allergenic components, CRD uses pure allergen proteins, produced by purification from natural allergen sources or recombinant expression of allergen- encoding complementary DNA.” 19 CRD is performed by automated methods based on either a fluorescence enzyme immunoassay or a microarray. Food Allergen Epitope Analysis A method that attempts to further refine allergen specific IgE testing using as antigens a panel of synthetic peptides, usually 15 to 20 amino acids in length, selected from a library of overlapping peptides that tile the entire sequence of the allergenic protein(s) of interest. IgE binding to each individual peptide is measured to create a “map” of Allergy Testing ©2021 eviCore healthcare. All Rights Reserved. 4 of 30 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Lab Management Guidelines V2.0.2021 epitopes.21,22 The test is usually performed using a microarray chip
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