1. Project Topic: <br />IgG ELISA food intolerance at-home test by Optimum Health Resource Laboratories. $299.00 <br />Purpose of the Tool: <br />The purpose of the IgG ELISA food intolerance test is to determine whether an individual is having an allergic reaction to a food that is causing he/she to be ill. There are four types of sensitivity reactions, types 1, 2, 3, and 4. The two that are most applicable to food allergies are types one and three. Type one involves an immediate reaction to a food. An example of this is when an individual who is allergic to peanuts has his throat swell shut immediately after eating one. <br />Type three reactions are called delayed onset sensitivity reaction. Reactions to a food that a patient is allergic to may not manifest for up to a week after the food is consumed. The immunoglobulin G (IgG) antibody combines to specific proteins found within food types. The accumulation of these IgG-food complexes within the bloodstream causes an individual to become ill. The IgG ELISA food intolerance test by Optimum Health Resource Laboratories is designed to determine the type of food, if any, the IgG antibody is binding to. Once the food is known, the patient will then be able to avoid consuming it in order to improve their health.<br />Explanation to the Patient: <br />When explaining the reason for a therapeutic procedure or a diagnostic test to a patient, it is important to speak using non-scientific words that he can understand. If I were to explain to a patient why I wanted him to have this test performed, I would say:<br />“I think the reason you are feeling sick is because you are allergic to a food that you are eating. I know that when most people think of a food allergy, they think of your throat swelling shut or breaking out in hives. This does not always have to be the case, though. You can have an allergy to a food that does not produce signs or symptoms for up to a week after you eat it. Immune cells attach to the food in your blood stream and they keep building up. If they keep building up, you begin to feel sick. The IgG ELISA food intolerance test will analyze your blood for these certain compounds and will be able to tell what food is causing this to occur.” <br />History of the Tool:<br />Delayed onset food sensitivity is a rather new scientific development concerning allergies, gaining credibility only within the past 20-25 years. It had previously been thought that the only type of allergic reactions that were caused by foods involved an immediate anaphylactic reaction. These types of allergic reactions are mediated by IgE antibody.<br />After it had been learned that IgG antibodies could also be involved in food allergies, companies began to develop testing methods for these types of reactions. When the IgG antibodies combine with a protein from food the patient is sensitive too, the process of mast cell and basophil degranulation begins ultimately ending in the initiation of the compliment cascade and a delayed sensitivity reaction. <br />Optimum Health Resource Laboratories had the desire to create an at-home test for individuals who think they may have a food allergy. The test uses the “finger stick” method. A small puncture is made in the patient’s thumb or index finger. The blood is then transferred to a test strip. After the test strip is completely red and dried, it is placed in the transport package and mailed to the laboratory to be analyzed.<br />Plausible Mechanism:<br />The ELISA/EIS (enzyme immunoassay) IgG test uses the blood sample from the patient and measures the presence of an antibody/antigen reaction when the patient’s serum is combined with different proteins contained in various foods. This allows for the specific food the patient is having a problem with to be recognized.5 <br />Optimum Health Resource Laboratories obtains their food samples from FDA approved sources to ensure reproducibility and extract qualities. The food extracts are then added to the surface of polystyrine micro-titre plates and are coated with a stabilizing polymer.5<br />When the patient’s blood sample is added to the food antigens, the IgG antibodies bind to any food that the patient is sensitive to. The sample is then rinsed and an enzyme is added. The enzyme reacts with the IgG antibody/antigen complex. The higher the amount of antibody/antigen substrate increases the intensity of the color produced.5<br />The level of reaction between the blood sample and the substrate is measured by the intensity of color emitted by the sample. Samples that remain unchanged are designated as food with no reaction. Samples with a tint of purple are called “rotate” foods, meaning the patient is mildly allergic to the food, but not allergic enough to cause a severe reaction. The company states that patients can consume these foods, but infrequently and in small amounts. The final categorization of samples is a dark purple color, which means patients are allergic and should avoid consuming these foods. These foods are most likely the cause of the patient’s health problem.5 <br />Safety of Use:<br />The “finger stick” method for drawing blood is minimally invasive. Therefore, this testing procedure is very safe. Patient must be sure to wash their hands with soap and water before performing the finger stick. Optimum Health Resource Laboratories provides the patient with alcohol wipes to further sterilize the area before drawing blood. The patient must also be sure not to reuse the lancet that is provided to puncture the skin. If these proper safety measures are taken before puncturing the skin, the IgG ELISA food intolerance test by Optimum Health Resource Laboratories is very safe to use.<br />Case Studies, Testimonials, and Methods of Marketing the Tool:<br />Optimum Health Resource Laboratories has a link on their website that shows quotations taken from publications about their product as well as testimonials concerning patients who used their testing procedure and had an improvement in their health. To the lay reader, many of the quotations seem very promising and hopeful. Some of the testimonials read: quot;
Your test saved my life!quot;
, quot;
The eczema cleared up immediately and he had fewer and fewer infections until, a few months later, he became a perfectly healthy, happy relaxed young boy.quot;
, quot;
She was cured of her ill-health after cutting out the identified allergic foods.quot;
, and quot;
... fat just seems to melt off...quot;
. <br />Optimum Health Resource Laboratories appears to be advertising to a group of people who have exhausted all other options. Readers must always be critical when considering treatment options. They must keep in mind that this is a company that is trying to earn a profit. The above are isolated remarks that may or may not be due to the testing procedure and the nutritional advice given by the company. Using the test may have indeed led an individual to losing weight; however, there was likely a diet change and exercise incorporated into the patient’s life as well. <br />Food allergies have been shown to cause weight gain as well as hyperactivity in children. Using the IgG ELISA food intolerance test by Optimum Health Resource Laboratories can help to identify the offending food and help eliminate the allergic process. However, a food allergy if not the only cause of the above health problems. A patient looking for assistance in losing weight and calming an overactive child should not rely upon the results of the allergy test alone to solve the problem.<br />Synopsis of Peer-reviewed Literature:<br />Numerous studies have been performed that show a link between various illnesses and the presence of IgG antibodies against food antigens. These studies examine the link between a food and an illness and whether removing the food from the diet reduces the circulating IgG levels and the illness in question.<br />One such study examined the effects of diet restriction in reducing migraine headache attacks. The study was performed in 2010 and was a randomized, double blind, cross-over control study involving 30 individuals, 28 females and 2 males ages 19-52, who suffer from migraines without aura. After a 6-week baseline was taken, IgG antibody levels against 266 food antigens were tested by the ELISA technique. The patients were then randomly assigned to a group that either included or excluded the foods that had the highest levels of IgG antibodies for six weeks. The groups were then placed on the opposite diet for another 6 weeks after a 2-week diet-free interval between the diets. The results of the original baseline IgG tests were unknown to both the patients and their physicians. The results were measured by the patients counting the number of days they experienced a headache as well as the number of separate headache attacks they experienced. One problem with the methods of this study is that of the 30 individuals that were tested, only 2 were males. In order for the results of this study to show more certainty with regards to males who suffer from migraines, more men should have been included in the original sample. Other than the gender ration of the sample, the methods of this study appear to be adequate.<br />During the elimination diet period, there was a significant drop in both the number of days a patient experienced a migraine (from 10.5 +/- 4.4 to 7.5 +/- 3.7; P < 0.001) as well as the number of migraine attacks (from 9.0 +/- 4.4 to 6.2 +/- 3.8; P < 0.001). This study shows that eliminating foods from the diet of a migraineur that cause an IgG sensitivity reaction can effectively reduce the number of headaches.9<br />As evidenced by the study described above as well as numerous other studies performed, it is widely accepted that IgG antibody production caused by food allergy can lead to numerous health challenges. However, the “finger stick” collection method used by Optimum Health Resource Laboratories has been called into question. Opponents of the “finger stick” method claim that small amount of dried blood provided by the patient results in errors during testing, and therefore poor results.<br />A study was performed in 1999 to examine whether a dried plasma card can produce the same results as a specimen obtained by venapuncture when testing for Helicobacter pylori IgG antibodies. 84 patients underwent testing for the H. pylori IgG antibody both with venapuncture as well as of drop of blood obtained by “finger stick” placed on two individual plasma collection cards. The correlation of the dried plasma results to the venapuncture results was assessed. <br />A problem in the methodology of this study is found when correlating the results to the IgG ELISA “finger stick” method for food sensitivity used by Optimum Health Resource Laboratories. The stability of the H. pylori IgG antibody may be increased when compared to the IgG antibodies of various foods that are tested. These potential differences may still account for an alteration the results of a “finger stick” IgG ELISA food intolerance tests when compared to a traditional venapuncture specimen collection.<br />The ELISA results of the study showed that there was a high degree of correlation between venapuncture and dried plasma card collection (r=0.98). The qualitative results of the first dried plasma specimen when compared to the venapuncture specimen differed in only 7 of 84 patients. The second plasma card differed in only 7 of 82 patients. The dried plasma cards were also both very sensitive and specific when compared to the venapuncture specimen. The first plasma card was 93% sensitive and 100% specific and the second card was 93% sensitive and 98% specific. A high degree of correlation between the two plasma cards was also indicated (r=0.996). These results indicate the “finger stick” dried plasma collection method had adequate sensitivity and specificity when compared to venapuncture when testing for H. pylori IgG antibodies.10 This shows that dried blood specimens obtained using the “finger stick” method can be considered an adequate alternative for venapuncture when testing for the presence of IgG antibodies due to a food sensitivity.<br />Patient Selection Criteria:<br />The Optimum Health Resource Laboratories IgG ELISA food intolerance test is a very safe procedure to perform. It is non-invasive and is designed by the company to be performed in the patient’s home. The dried blood sample is then mailed back to the laboratory and is tested against 96 possible food allergens.<br />The test can help make a patient aware of the cause of their illness and help them to take steps toward achieving wellness. The fact that the test simply requires a “finger stick” makes it a very safe and non-invasive option for anyone.<br />Conclusion:<br />Delayed onset food allergies are become more and more common in the world today, especially with the advent of genetically modified foods. A food allergy can manifest itself in many different fashions, including migraines, dermatitis, irritable bowel syndrome, and fibromyalgia. Any individual suffering from a chronic illness such as these may indeed be suffering from a food sensitivity. <br />Foods such as eggs, milk, corn, and wheat commonly cause allergic reactions in individuals. The Optimum Health Resource Laboratories IgG ELISA food intolerance test examines these four foods as well as 92 other foods for a possible allergic reaction. At home, a patient has to wet a plasma collection card with blood obtained through a non-invasive “finger stick.” The sample is then analyzed for the presence of IgG antibodies in response to the various foods in question. The Optimum Health Resource Laboratories then sends a report to the patient that outlines the results and explains what foods the patient should avoid.<br />Questions have been raised as to whether dried plasma collection cards are as accurate as standard venapuncture collection methods. Studies have been performed illustration that dried plasma collection is both sensitive and specific when compared to venapuncture collection. This allows an individual who suspects he may have a food sensitivity to safely perform the test in his own home and mail the specimen to the lab.<br />The Optimum Health Resources IgG ELISA food intolerance test has been shown to be safe and reliable. Its results can help individuals who have been suffering from chronic health conditions such as migraines and irritable bowel syndrome find the cause of their problems and begin making dietary changes to improve health.<br />References<br />Alpay K, Ertas M, Orhan EK, Ustay DK, Lieners C, Baykan B. Diet restriction in migraine, based on IgG against foods: a clinical double-blind, randomised, cross-over trial. Cephalalgia. 2010 Jul;30(7):829-37. Epub 2010 Mar 10.<br />Kay AB (2000). quot;
Overview of 'allergy and allergic diseases: with a view to the future'quot;
. Br. Med. Bull. 56 (4): 843–64.<br />Kearney DJ, Boes L, Peacock JS. Use of a dried plasma collection card for simplified diagnosis of Helicobacter pylori infection. Aliment Pharmacol Ther. 1999 Nov;13(11):1531-4.<br />Lessof, M.H. and Kemeny, D.M., Non-IgE-mediated reactions to food: how much is allergic? Ann Allergy 1987; 59:90-92.<br />Miller, Sheryl B. “IgG Food Allergy Testing by ELISA/EIA, What Do They Really Tell Us?” http://www.tldp.com/issue/174/IgG%20Food%20Allergy.html Accessed 03/10/11.<br />Optimum Health Resources Laboratories. “The IgG ELISA Food Intolerance Test.” http://www.optimumhealthresource.com/pinprick.html. Accessed 03/09/11.<br />Optimum Health Resource Laboratories. “What others are saying about our services.” http://www.optimumhealthresource.com/whatotherssay.html. Accessed 03/09/11<br />Sinn N. Nutritional and dietary influences on attention deficit hyperactivity disorder. Nutr Rev. 2008 Oct;66(10):558-68.<br />Stanworth, D.R., Immunochemical aspects of human IgG4. Clin. Rev. Allergy 1983; 1:183-95.<br />vel Szic KS, Ndlovu MN, Haegeman G, Vanden Berghe W. Nature or nurture: let food be your epigenetic medicine in chronic inflammatory disorders. Biochem Pharmacol. 2010 Dec 15;80(12):1816-32. Epub 2010 Aug 3.<br />