Medical Policy

This document addresses selected unproven blood, serum and cellular allergy and toxicity tests. Allergy testing is used to determine if a symptom could be the result of an allergic reaction (involving antibodies and histamine release). The document does not address generally accepted diagnostic tools such as percutaneous (scratch, prick, or puncture) tests, the allergen-specific serum immunoglobulin E (IgE) test, food elimination diets and oral food challenges (double-blind, placebo-controlled food challenge).

Note: Please see the following related document for additional information:

• MED.00059 Idiopathic Environmental Illness (IEI)

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Investigational and Not Medically Necessary:

The following blood, serum and cellular allergy or toxicity tests are considered investigational and not medically necessary: 

• Antigen leukocyte cellular antibody test (ALCAT); or
• Basophil activation test (BAT); or
• Cytotoxic test; or
• HEMOCODE Food Tolerance System; or
• IgG food sensitivity test; or
• Immuno Blood Print test; or
• Leukocyte histamine release test (LHRT); or
• Mediator Release Test.

This document describes clinical studies and expert recommendations, and explains whether certain blood, serum and cellular allergy or toxicity tests are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Certain blood tests claim to find food allergies or food sensitivities. These tests check how blood cells or proteins in the blood react to different foods. They are different from standard allergy tests, which measure a protein called immunoglobulin E (IgE). IgE tests are a proven way to check for food allergies and are not addressed in this document. The tests in this document include:

• Antigen leukocyte cellular antibody test (ALCAT)
• Basophil activation test (BAT)
• Complement Antigen Test for delayed food allergy
• Cytotoxic test
• HEMOCODE Food Tolerance System
• immunoglobulin G (IgG) food sensitivity test
• BloodPrint test
• Leukocyte histamine release test (LHRT)
• Mediator Release Test (MRT)

Some of these tests are sold online or through wellness clinics. They may test for reactions to dozens or even hundreds of foods at once.

What the Studies Show

The American Academy of Allergy, Asthma and Immunology (AAAAI) says these tests should not be used to check for food allergies. The National Institute of Allergy and Infectious Diseases (NIAID) also recommends against them. These groups reviewed the available research and found that the tests have not been shown to work for finding food allergies.

One common type of test measures a blood protein called immunoglobulin G (IgG) in response to foods. Studies show that IgG levels go up when people eat certain foods. This is a normal body response and does not mean the food is causing harm. Because of this, a positive IgG test result does not mean a person is allergic or sensitive to that food.

The antigen leukocyte cellular antibody test (ALCAT) and the cytotoxic test work by watching how white blood cells change when mixed with food extracts. The U.S. Food and Drug Administration (FDA) has said that cytotoxic testing is unproven. Reviews of published research found that ALCAT test results are not consistent from one test to the next and do not match up with actual symptoms.

The mediator release test (MRT) is a patented test sold by one company. No peer-reviewed published research results are available to support its use.

None of these tests have been cleared by the FDA. They have not been tested against a proven method, such as a food challenge supervised by a doctor, to see if they give correct results.

Is This Clinically Appropriate?

Based on the available published evidence, the tests listed above are not considered clinically appropriate. Better studies are needed to know if any of these tests improve health. People who think they may have a food allergy should talk to their healthcare provider about proven testing methods. Use of unproven tests may lead to treatment that does not work as well and possible harm.

(Return to Description/Scope)

Summary

Multiple professional society guidelines, expert panels, and international bodies uniformly recommend against the clinical use of nonstandardized blood, serum, and cellular allergy and toxicity tests for diagnosing food allergy or intolerance. The available primary literature on these tests consists predominantly of small, single-center studies with significant methodological limitations, including absence of blinding, lack of validated reference standards, and failure to demonstrate that test results improve clinical outcomes. Recent studies evaluating food-specific immunoglobulin G (IgG) antibodies continue to show that IgG positivity reflects dietary exposure rather than clinically actionable food sensitivity, with minimal predictive value for guiding elimination diets. None of the nine tests addressed in this document have received clearance from the United States Food and Drug Administration (FDA), and no registered clinical trial has evaluated the diagnostic accuracy of any of these tests against a validated reference standard such as a double-blind, placebo-controlled food challenge.

Discussion

Professional Society and Federal Guideline Positions

The National Institute of Allergy and Infectious Diseases (NIAID) Expert Panel Guidelines for the Diagnosis and Management of Food Allergy recommend against the use of 12 nonstandardized tests for the routine evaluation of immunoglobulin E (IgE)-mediated food allergy, including basophil histamine release and activation, cytotoxicity assays, allergen-specific immunoglobulin G4 (IgG4), and the mediator release assay (Boyce, 2010). The panel stated that "there is a lack of evidence demonstrating that any of these nonstandardized tests has any value in the diagnosis of food allergy" and that their use "may result in false positive or false negative diagnoses, leading to unnecessary dietary restrictions or delaying the appropriate diagnostic workup."

The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) Joint Task Force Practice Parameter on Food Allergy recommends against unproved tests including allergen-specific immunoglobulin G (IgG) measurement and cytotoxicity assays for the evaluation of food allergy, and states that food-specific IgG and IgG4 antibodies in serum are not recommended for diagnosing non-IgE-mediated food-related allergic disorders (Sampson, 2014). The 2008 AAAAI and ACAAI Practice Parameter on Allergy Diagnostic Testing concluded that cytotoxic testing is among the tests "for which there is no evidence of diagnostic validity" and characterized the leukocyte histamine release test (LHRT) as a valuable research tool but not a validated clinical diagnostic test (Bernstein, 2008). A 2022 update to the drug allergy practice parameter noted that in vitro tests such as basophil activation tests (BATs) do not have any well-validated commercial assays in the United States (Khan, 2022).

A joint AAAAI and European Academy of Allergy and Clinical Immunology (EAACI) consensus report on oral food challenge standardization stated that "other modalities lacking sufficient evidence to recommend their use include allergen-specific IgG or IgG4 testing, pulse testing, electrodermal testing, lymphocyte activation testing, cytotoxic testing and applied kinesiology testing" and noted that the BAT is not currently widely available for clinical practice (Sampson, 2024). The American College of Gastroenterology (ACG) clinical guideline on eosinophilic esophagitis (EoE) recommends against the use of currently available allergy testing, including serum IgG testing, to direct food elimination diets for the treatment of EoE, noting that allergy test-based diets have the lowest response rates in meta-analyses (Dellon, 2025).

Immunoglobulin G (IgG) and Immunoglobulin G4 (IgG4) Food Sensitivity Testing

Measurement of food-specific immunoglobulin G (IgG) and immunoglobulin G4 (IgG4) antibodies is frequently performed in research settings as a diagnostic and prognostic tool to determine response to allergy treatments. However, specific IgG and IgG4 results do not correlate with oral food challenges and are not recommended for diagnosing food allergies. IgG antibody testing for food intolerance is based on the premise that circulating food-specific IgG antibodies indicate an immune-mediated sensitivity response. However, the presence of IgG antibodies to foods is a normal physiological response to dietary exposure and does not reliably distinguish individuals with clinically relevant food intolerance from healthy individuals.

A 2018 review article identified several studies evaluating food-specific serum IgG, but none were well-designed trials and many lacked controls (Hammond, 2018). The European Academy of Allergy and Clinical Immunology (EAACI) has noted that testing for blood IgG4 against different foods is being performed with increasing frequency using large-scale screening panels, but that many serum samples show positive IgG4 results in the absence of corresponding clinical symptoms.

A retrospective case-control study comparing food-specific immunoglobulin E (IgE), IgG, and IgG4 in 245 children with allergic diseases and healthy controls reported that IgG had the best overall discriminative performance among the three antibody types (Youden index, J = 0.612). However, the case-control design, which compares individuals with known allergic disease to healthy controls, inherently inflates diagnostic accuracy measures (Cai, 2026). Agreement between IgE and IgG results was poor (kappa < 0.4), confirming these assays measure distinct immunologic phenomena. The investigators cautioned that IgG and IgG4 results alone are not recommended for diagnostic decision-making.

A retrospective analysis of 1237 underweight individuals examined associations between food-specific IgG antibody levels for 14 food antigens and body mass index (BMI) (Zeng, 2025). Wheat-specific IgG showed an inverse correlation with BMI-for-age Z-scores in children (R² = 2.18%), and soybean-specific IgG showed an inverse correlation with BMI in adults (R² = 1.67%). A multivariate model incorporating all 14 IgG antibodies was not statistically significant in adults (p=0.114), indicating limited standalone clinical predictive utility. The investigators acknowledged that professional societies do not recommend IgG testing for food allergy diagnosis.

A single-blinded, sham-controlled randomized trial evaluated a food-specific IgG-based elimination diet in 98 adults with episodic migraine (Zhao, 2025). Individuals randomized to eliminate IgG-positive foods demonstrated greater improvement in Migraine Disability Assessment scores compared to those randomized to eliminate IgG-negative foods (between-group difference, -8.7 points; 95% confidence interval [CI], -14.5 to -3.0; p=0.0033), along with reductions in interleukin-6 and tumor necrosis factor-alpha. However, the sham comparator eliminated IgG-negative foods rather than maintaining an unrestricted diet, blinding was not verified, and the trial did not demonstrate significant improvement in several secondary endpoints including migraine-specific quality of life, depression, and anxiety. This single-center trial does not establish clinical utility for IgG testing in the absence of replication, particularly given that no major allergy or neurology guideline recommends IgG-based dietary interventions for migraine.

IgG antibody testing for food intolerance is offered by Clinical Laboratory Improvement Amendments (CLIA)-approved laboratories. The BloodPrint test (Immuno Laboratories, Fort Lauderdale, FL) and panels from US BioTek Laboratories (Shoreline, WA) are examples of commercially available IgG food sensitivity tests. A search of the peer-reviewed scientific literature did not identify published clinical validation studies for these specific branded panels.

Leukocyte-Based Assays

Several tests in this document share a common mechanistic basis in observing leukocyte responses upon exposure to food antigens. These include the antigen leukocyte cellular antibody test (ALCAT), cytotoxic testing, and the leukocyte histamine release test (LHRT).

The antigen leukocyte cellular antibody test (ALCAT) measures whole blood leukocyte activity to identify allergens that cause an increase in leukocyte size or number changes. The ALCAT has been promoted as a diagnostic test for food allergy or intolerance and as a tool to establish elimination diets. One study explored the use of ALCAT results as the basis for elimination diet treatment in 72 individuals (45 children and 27 adults) with various symptoms of unproven etiologies and reported improvement rates ranging from 32% for childhood hyperactivity to 83% for arthritis-related symptoms (Mylek, 1995). However, the study lacked a control group or blinding. Review articles have concluded that ALCAT test results are not reproducible and do not correlate with clinical symptoms (Hammond, 2018; Wuthrich, 2005).

Cytotoxic testing, also known as Bryan's Test or the leukocytotoxicity test, involves exposing leukocytes to food extracts and observing changes in cell morphology. The U.S. Food and Drug Administration (FDA) concluded in a formal compliance policy guide that the cytotoxic test is "an unproven diagnostic procedure unsupported by the scientific literature or well-controlled studies and clinical trials" and stated that marketed test kits would be considered adulterated and misbranded without FDA approval (FDA, 1995).

The leukocyte histamine release test (LHRT) involves observing leukocytes from an allergic individual for the release of histamine in the presence of an antigen. There is a lack of well-designed controlled studies evaluating the diagnostic and clinical utility of the LHRT. Allergy diagnostic testing guidelines characterize the LHRT as a valuable research tool for in vitro investigations of allergy but not a validated clinical diagnostic test (Bernstein, 2008).

Basophil Activation Testing (BAT)

The BAT assesses the response of basophils in a sample of fresh blood to allergen cross-linking of immunoglobulin E (IgE), using the activation markers CD63 or CD203c as measured by flow cytometry. The BAT has been proposed as a test to determine allergic responses, including food allergies, insect venom allergies, drug allergies, and chronic urticaria. Basophils have a half-life of less than a week, which imposes a time limitation on performing the test (Hoffmann, 2015). As noted in professional society guidelines, the BAT does not have well-validated commercial assays available in the United States, and its use remains largely confined to research settings.

Mediator Release Testing (MRT)

MRT is a patented test from Oxford Biomedical Technologies (Oxford, UK). No published literature on the MRT was identified in the peer-reviewed scientific literature. The National Institute of Allergy and Infectious Diseases (NIAID) guidelines explicitly list the mediator release assay (including the Lifestyle, Eating, And Performance [LEAP] diet protocol) among nonstandardized tests not recommended for the routine evaluation of food allergy (Boyce, 2010). The American Academy of Allergy, Asthma and Immunology (AAAAI) food allergy practice parameter does not mention the MRT as a recognized test for the evaluation of potential allergy (Sampson, 2014).

Proprietary Branded Tests

The HEMOCODE Food Tolerance System (Gemoscan, Ontario, Canada) is a proprietary test not regulated by the U.S. Food and Drug Administration (FDA). A search of the peer-reviewed scientific literature did not reveal clinical validation studies for the HEMOCODE system.The Complement Antigen Test (Sage Medical Laboratories, Ormond Beach, FL) measures immunoglobulin G (IgG) and components of complement to identify delayed food allergies. A search of the peer-reviewed scientific literature did not reveal any publications related to the Complement Antigen Test. This test should not be confused with complement assays or complement testing, which measure the activity of the complement system and are routinely used to diagnose and monitor autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus.

Regulatory and Coverage Status

No U.S. Food and Drug Administration (FDA)-labeled indications have been identified for any of the tests included in this document. None of these tests have undergone FDA premarket review. The only FDA-cleared in vitro food allergy diagnostics are immunoglobulin E (IgE)-based assays, which are standard of care and are not addressed by this document. The FDA has formally declared cytotoxic testing unproven in Compliance Policy Guide Section 370.100 (FDA, 1995). The remaining tests are marketed as laboratory-developed tests performed in Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.

The Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD) on Allergy Testing (L36402) (2024) states that allergy tests must have "proven efficacy as demonstrated through scientifically valid peer reviewed published medical studies" and notes that Medicare excludes investigational or experimental services from coverage.

According to the National Institute of Allergy and Infectious Diseases (NIAID), food allergies should be suspected in the following: (1) individuals presenting with anaphylaxis or select symptoms that occur within minutes to hours of ingesting food, especially in young children or if symptoms have followed the ingestion of a specific food on more than one occasion; (2) infants, young children and selected older children diagnosed with conditions such as moderate to severe atopic dermatitis (AD), eosinophilic esophagitis (EoE), enterocolitis, enteropathy, and allergic proctocolitis; and (3) adults diagnosed with EoE (Boyce, 2010).

The standard of care in the medical community for diagnosing food allergies includes a medical history, a physical examination and diagnostic tools, such as the percutaneous (scratch, prick, or puncture) tests, the allergen-specific serum immunoglobulin E (IgE) test, food elimination diets and oral food challenges (double-blind, placebo-controlled food challenge).

Unproven blood, serum and cellular allergy and toxicity tests, addressed in this document, are described below.

Antigen Leukocyte Cellular Antibody Test (ALCAT)

ALCAT measures whole blood leukocyte activity to identify allergens that cause an increase in leukocyte activity. An electronic counter measures the change in number and size of leukocytes that have been incubated with purified food or mold extracts. A histogram is produced which reflects the cell count and cell size. The test samples are then compared with a "Master Control" graph. The ALCAT has been promoted as a diagnostic test for food allergy or intolerance (chemical sensitivities) in conditions such as, but not limited to, arthritis, urticaria, bronchitis, gastroenteritis, childhood hyperreactivity, rhinitis, and atopic dermatitis. Typically, the results are used to establish elimination diets for these diseases. The ALCAT is manufactured by Cell Science Systems, Corp. (CSS), located in Deerfield Beach, Florida, which has a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Basophil Activation Test (BAT)

The BAT is proposed as a test to determine allergic response, including food allergies and also insect venom allergies, drug allergies and chronic urticaria. The BAT assesses response of basophils in a sample of fresh blood to allergen cross-linking of immunoglobulin E (IgE), using the activation marker CD63 or another activation marker such as CD203c. The BAT can be performed in most research laboratories using a flow cytometer, which can measure the fraction of reactive or activated basophils in the sample. There is a time limitation on performing the test on a blood sample since basophils have a half-life of less than a week (Hoffmann, 2015).

Cytotoxic Testing

Cytotoxic testing for food allergies is purported to be useful for diagnosing food allergies and food intolerances. The premise of cytotoxic testing is based on the theory that mixing an individual’s white blood cells with an antigen to which that individual is allergic results in injury to the cells. This test involves the exposure of leukocytes to the presence of food extracts to which the individual is allergic. A technician then observes the unstained cells for changes in the size, shape, appearance or integrity. Swelling, vacuolation or other cytotoxic changes in cell morphology are taken as evidence of an allergic reaction to food.

Immunoglobulin G (IgG)-Mediated Food Sensitivity Testing

Immunoglobulin G (IgG) antibody testing for food intolerance is based on the premise that elevated levels of IgG antibodies are an indicator of food intolerances. Immunoglobulin G (IgG) is frequently divided into four subclasses. Selective deficiencies in one or more of the four IgG subclasses may be seen in some individuals with repeated infections. IgG subclasses can be measured in a manner similar to those for allergen-specific immunoglobulin E (IgE). Controversy exists regarding whether increases of immunoglobulin G4 (IgG4) are valid indicators of either food allergy diagnosis or clinical efficacy after immunotherapy.

Leukocyte Histamine Release Test (LHRT)

The leukocyte histamine release test (LHRT, basophil histamine release test) measures the amount of histamine released in the presence of an antigen. Varying concentrations of an allergen extract are added to the peripheral blood leukocytes of the individual being tested. Histamine is normally released as a result of the interaction of allergen with cell-bound immunoglobulin E (IgE) antibodies. If the individual is allergic to a specific antigen, the leukocytes should release histamine in vitro upon stimulation of that antigen, unless the individual has recently been exposed and their cells are in a refractory state. A limited number of allergens can be tested using a single aliquot of blood.

Mediator Release Test (MRT)

The mediator release test (MRT) is a patented test from Oxford Biomedical Technologies (formerly the Signet Diagnostic Corporation). According to the manufacturer, the MRT measures volumetric changes in lymphocytes, neutrophils, monocytes and eosinophils after food or food-chemical challenges. Test results are reported as ‘non-reactive’, ‘moderately reactive’ or ‘reactive’ and can be used to develop a food sensitivity eating plan marketed by clinics operated by Oxford Biomedical Technologies.

Allergen: Any substance that can cause an allergic reaction.

Allergy: An acquired potential for developing adverse reactions that are mediated by the immune system (via immunoglobulin E (IgE) antibodies).

Antibody: A type of protein produced by the immune system in response to substances called antigens.

Antigen: Any substance that, when introduced into the body, evokes an immune response and stimulates the production of antibodies.

Atopic dermatitis: A skin disease characterized by areas of severe itching, redness, and scaling.

Basophil: A type of white blood cell known as a granulocyte. Granulocytes consist of neutrophils and eosinophils, as well as basophils.

CLIA: Clinical Laboratory Improvement Amendments. Passed by the U.S. Congress in 1988, CLIA established quality standards for all non-research laboratory testing conducted on specimens obtained from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

Complement assay (test): A test that measures the activity of a group of 9 proteins (numbered C1-C9) that travel via the bloodstream, work with the immune system and play a role in the development of inflammation.

Gastroenteritis: Inflammation of the stomach and intestines.

Leukocytes: White blood cells.

Rhinitis: Inflammation and irritation of some internal areas of the nose; also referred to as a runny nose.

Urticaria: Red, raised areas of skin that are usually a sign of an allergic reaction; also referred to as hives.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:
When the code describes a food allergy testing procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer-Reviewed Publications:

1. Cai S, Jiang L, Lu J, et al. Analysis of food-specific IgE, IgG, and IgG4 antibodies in children with allergic diseases. Am J Transl Res. 2026; 18(1):605-617.
2. Hammond C, Lieberman JA. Unproved diagnostic tests for food allergy. Immunol Allergy Clin North Am. 2018; 38(2):153-163.
3. Hoffmann HJ, Santos AF, Mayorga C, et al. The clinical utility of basophil activation testing in diagnosis and monitoring of allergic disease. Allergy. 2015; 70(11):1393-1405.
4. Khan DA, Banerji A, Blumenthal KG, et al. Drug allergy: a 2022 practice parameter update. J Allergy Clin Immunol. 2022; 150(6):1333-1393.
5. Mylek D. ALCAT Test results in the treatment of respiratory and gastrointestinal symptoms, arthritis, skin and central nervous system. Rocz Akad Med Bialymst. 1995; 40(3):625-629.
6. Wuthrich B. Unproven techniques in allergy diagnosis. J Investig Allergol Clin Immunol. 2005; 15(2):86-90.
7. Zeng YC, Li CY, Song XL, et al. Food-specific IgG antibodies and body mass index: multivariate analysis of clinical correlations in underweight populations. Front Immunol. 2025; 16:1650705.
8. Zhao Z, Yang M, Wan F, et al. Food-specific IgG-based elimination diet decreased IL-6, TNF-alpha, and CGRP and improved symptoms in adults with migraine. Front Nutr. 2025; 12:1720389.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bernstein IL, Li JT, Bernstein DI, et al. American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI). Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008; 100(3 Suppl 3):S1-S148.
2. Boyce JA, Assa'ad A, Burks AW, et al. National Institute of Allergy and Infectious Diseases (NIAID). Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010; 126(6 Suppl):S1-S58.
3. Centers for Medicare and Medicaid Services. Local Coverage Determination for Allergy Testing (L36402). Revision effective 09/26/2024. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=36402. Accessed on May 15, 2026.
4. Centers for Medicare and Medicaid Services. National Coverage Determination for Food Allergy Testing and Treatment. NCD #110.11. Effective 10/31/1988. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=266&ncdver=1. Accessed on May 15, 2026.
5. Dellon ES, Muir AB, Katzka DA, et al. American College of Gastroenterology (ACG). ACG clinical guideline: diagnosis and management of eosinophilic esophagitis. Am J Gastroenterol. 2025; 120(1):31-59.
6. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). Page last modified 05/14/2026. Available at: https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments. Accessed on May 15, 2026.
7. Sampson HA, Aceves S, Bock SA, et al. American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology (JCAAI) Joint Task Force on practice parameters. Food allergy: a practice parameter update-2014. J Allergy Clin Immunol. 2014; 134(5):1016-1025.
8. Sampson HA, Arasi S, Bahnson HT, et al. American Academy of Allergy, Asthma & Immunology (AAAAI) and European Academy of Allergy and Clinical Immunology (EAACI). AAAAI-EAACI PRACTALL: standardizing oral food challenges: 2024 update. Pediatr Allergy Immunol. 2024; 35(11):e14276.
9. U.S. Food and Drug Administration. CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases. Revised 3/95. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-370100-cytotoxic-testing-allergic-diseases. Accessed on May 15, 2026.

1. American Academy of Allergy, Asthma and Immunology (AAAAI). Available at: https://www.aaaai.org/. Accessed on May 15, 2026.
2. U.S. Food and Drug Administration. Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry. February 2007. Content current as of 05/06/2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration. Accessed on May 15, 2026.

Antigen Leukocyte Cellular Antibody Test (ALCAT)
Basophil Histamine Release Test
BloodPrint Test
Bryan's Test (cytotoxic testing for food allergy)
Complement Antigen Test for Delayed Food Allergies
Cytotoxic Leukocyte Test
Cytotoxic Test
HEMOCODE Food Tolerance System
IgG Food Sensitivity Testing
Leukocyte Histamine Release Test (LHRT)
Mediator Release Test
US BioTek Laboratories Antibody Assessment Panel

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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