1. The ALCAT food allergy test: An evaluation of efficacy and clinical applicability Andrea Martinson NTR5502 March 2011

2. Allergy in America Allergies are the 6th leading cause of chronic disease in the US 25% of these cases may be related to foods Prevalence is rising in children http://allergyasthma.wordpress.com/

3. What is food allergy? Allergy: an exaggerated immune response to a specific protein allergen in the environment Anaphylactic reaction with IgE response Atopy: familial predisposition to the production of IgE antibodies to environmental allergens Can manifest as childhood asthma, allergic rhinitis, eczema http://offthemark.com/search-results/key/food+allergy/

4. What is food hypersensitivity? Delayed food allergies: Repeated exposure to a food antigen can produce delayed allergic-like responses or hypersensitivities IgG antibodies have been shown to increase small intestine permeability Diverse symptoms, may not be evident for hours to days after initial exposure Eg. Celiac disease Up to 60% of the population may suffer from undetected food allergies Patients often experience short-term relief after ingesting foods which are later demonstrated to be the cause of their chronic symptoms http://www.dropyourallergies.com

5. Food Allergy Testing Immediate Food Hypersensitivity Delayed Food Hypersensitivity Many tests can be used to determine IgE allergies to pollens, mites, insect venom, latex, drugs, and foods RAST test: blood testing for specific IgE antibodies Skin prick testing (SPT) Standardized allergen extracts There are a number of tests for delayed food allergies, which remain controversial IgG ELISA test Mediator Release Test (MRT) ALCAT http://www.nosneezes.com

6. ALCAT: Activated Leukocyte Cellular Antigen Test Developed by Cell Science Systems Corp., an FDA-inspected and registered medical device manufacturer that operates a CLIA-certified laboratory in Deerfield, FLA Developed to identify the body’s response to possible allergy-producing food antigens ALCAT is an in-vitro food allergy test that identifies changes in blood cell sizes The ALCAT identifies reactions to over 350 foods, chemicals and other substances associated with inflammation

7. How does it work? Blood cells are lysed and incubated with purified food extracts Contact between allergens and cells can cause autolysis, called allergic autocytotoxicity Change in cell size is measured automatically using ROBOCat II automated liquid handling system designed to measure blood cells by number and size measures changes in a blood cell’s electrical resistance Percent shift in cell volume: >13% is positive <9% is negative Mechanism of change in cell size is unknown http://www.alcat.com/thetechnology.html

8. Marketing and Testimonials The ALCAT website targets people who have symptoms like migraine headaches, chronic fatigue, skin disorders, asthma, IBS symptoms, weight gain, and many others Testimonials are used to illustrate the claimed effects of using the results of this test as part of an elimination diet method of treatment Research supporting the ALCAT system is displayed on the website. They claim that: “It is the only test shown to correlate with clinical symptoms by double blind oral challenges, the gold standard” Supported by The International & American Associations of Clinical Nutritionists and American Academy of Anti-Aging Medicine Supporting and participating health care professionals are listed on the website

9. Available Panels 50, 100, 150, and 200-food panels 50 functional and medicinal herbs Female herbs Male herbs Food additives/Food colorings Molds Environmental Chemicals A number of comprehensive wellness panels http://ibstreatmentcenter.blogspot.com/2011/02/understanding-food-allergies.html

10. Supporting Evidence for the ALCAT A number of studies have reported >90% reproducibility of the ALCAT Comparing healthy football players to patients with suspected food sensitivities using ALCAT test: 5 positive test results in the football players 47 positive results in the patient group (Sandberg & Pasula, 1988)

11. Supporting Evidence: ALCAT and GI Disorders Berardiet al., 2009 Tested15 patients affected by GI symptoms who were negative for IgE allergies (prick and/or RAST) Elimination diet for 2 months according to ALCAT results 54% showed improvements Fell et al., 1991 Patients with IBS symptoms 1. Two-week elimination diet based on ALCAT results 2. Six 1-week food challenges using 3 positive foods and 3 negative foods 3. Six-week exclusion diet removing foods identified by ALCAT 43 of 60 positive foods produced symptoms, while only 11 of 60 negative foods produced symptoms Symptom scores were higher in positive food group 2/3 of the patients improved when eliminating positive foods

12. Supporting Evidence: ALCAT and Weight Loss Gaby, 1998: 27 obese patients who had difficulty losing weight on a reduced-calorie diet were evaluated for white blood cell food-induced reactions using ALCAT. Patients were exhibiting multiple symptoms, including gastrointestinal reflux, chronic fatigue, headache and other chronic disorders associated with food sensitivities. Iso-caloric elimination diets based on ALCAT test results promoted weight loss, favoring fat loss over muscle 98% of the subjects following the ALCAT plan either lost scale weight or improved their body composition Other benefits reports included an increased sense of well being, improved physical performance, and decreased bloating and digestive problems. This study suggests that delayed food hypersensitivities may interfere with weight loss, regardless of caloric restriction!

13. Supporting Evidence: Cutaneous Disorders Berardiet al., 2009 45 of 52 patients with angioedema and chronic urticaria showed full remission upon elimination of the foods identified by ALCAT Mullin et al., 2010 Patients with cutaneous disorders, who were negative with skin prick and RAST, followed a 2-month elimination diet of foods identified using the ALCAT 86% exhibited a dramatic improvement in symptoms 14% showed no change or did not follow the diet http://www.timtim.com/drawing/view/drawing_id/718

14. Evidence Refuting the ALCAT Most people develop IgG antibodies to foods that they eat, and some researchers believe this is a normal immune response indicating exposure, not an allergy Recent studies have shown that the IgG response may even be protective against the development of IgE food allergy Hence, there is no convincing evidence to suggest that this test has any diagnostic value for allergy Morris, 2009: “Testing for IgG4 antibodies to diagnose food intolerances is best avoided. According to UK and European allergy opinion leaders, IgG responses to food are a normal physiologic phenomenon and raised food-specific IgG has no predictive role for food allergies or intolerances…Another pseudo pseudoscientific testing modality called blood leucocytotoxic testing (ALCAT test) has been available since 1956 but has no proven diagnostic value in allergy”

15. Evidence Refuting the ALCAT Several investigators have reported that the ALCAT is an inappropriate modality for testing food allergy in clinical practice due to poor reproducibility and lack of scientific and clinical proof of efficacy A study of antibody responses to milk proteins in patients with milk-protein intolerance proved by oral challenge found no increase in IgG antibodies (Gerezet al., 2010)

16. Effectiveness, Safety, and Practicality of ALCAT in a Clinical Setting Pros Cons Test is easy and safe, requiring only a simple blood draw No safety concerns or adverse effects have been reported All components are modular, allowing easy troubleshooting and replacement The software is compatible with all versions of Microsoft Windows The instrument is manufactured using Good Manufacturing Practices in a FDA Registered Medical Device Establishment Test comes with complementary test results guide for interpretive ease Cost of separate panels ranges from $99-$1099 Samples must be sent to participating labs and it may take time to receive results Possibility of poor reliability and lack of scientific proof of efficacy Possible difficulty in acquiring blood sample – requires external referral to a lab

17. Patient Selection Criteria Patients who may benefit from IgG food antigen testing with the ALCAT include, but are not limited to, those with the following symptoms: Headaches Weight gain Fatigue Generalized achiness or arthritis Gastrointestinal dysfunction Skin disorders Attention deficit hyperactivity disorder Unresponsive to other methods of treatment The test can be used on patients of any age

18. Conclusion The ALCAT is a simple blood test that examines the response of white blood cells to various foods While some researchers refute the claims that the IgG response is an accurate indication of a delayed food allergy, the ALCAT has plenty of evidence from randomized clinical trials, case studies, and testimonials, to validate its claims Although the cost of the panels can be quite high, this test seems to be a safe and reliable means of identifying potential food allergens, and is quite easily accessible to health practitioners

19. References Akmal, M., Khan, S.A., Khan, A.Q. (2009). The effect of the ALCAT test diet therapy for food sensitivity in patients with obesity. Middle East Journal of Family Medicine 7(3): 133-137. Berardi, L., De Amici, M., Vignini, A., Mantegna, G., Mosca, M. (2009). ALCAT test identifies food intolerance in patients with gastrointestinal symptoms. Eur J Allergy and ClinImmun 90(64): 1280-1285. Berardi, L., De Amici, M., Vignini, A., Torre, C., Mosca, M. (2009). Food intolerance in patients with cutaneous diseases: diagnostic value of the ALCAT test. Eur J Allergy and ClinImmun 90(64): 644-650. Cell Science Systems. (2011). ALCAT Worldwide. Retrieved from http://www.alcat.com/aboutus.php [February 23, 2011] Fell, P.J., Brostoff, J., O’Donnell, H., O’Connor, A., Charig, E. (1988). ALCAT – “A new test for food-induced problems in medicine?”. Presented at the Annual Meeting of the American Academy of Otolaryngic Allergy, Washington, D.C. Retrieved from http://www.alcat.com/studies_links [February 23, 2011] Fell, P.J., Soulsby, S., Brostoff, J. (1991). Cellular responses to food in irritable bowel syndrome – an investigation of the ALCAT test. J Nut Med 2:143-149. Gaby, A.R. (1998). The role of hidden food allergy/intolerance in chronic disease. Alternative Medicine Review 3(2): 90-100. Gerez, I.F.A., Shek, L.P.C., Chng, H.H., Lee, B.W. (2010). Diagnostic tests for food allergy. Singapore Med J 51(1): 4-8. Hoj, L. (1995). Food intolerance in patients with angioedema and chronic urticaria: an investigation by RAST and ALCAT test. Eur J Allergy and ClinImmun26(50): 316-322. Morris, A. (2009). Atopy, anamnesis and allergy testing. InnovAiT2(3): 158-165. Mullin, G.E., Swift, K.M., Lipski, L., Turnbull, L.K., Rampertab, S.D. (2010). Testing for food reactions: the good, the bad, and the ugly. Nutrition in Clinical Practice 25(2): 192-198. Sandberg, D.H., Pasula, M.J. (1988). A comparison of the ALCAT test for food reactions amongst 2 population sub-groups. Annals of Allergy, presented at the 5th Annual Congress of the American College of Allergy and Immunology, Los Angeles, CA.