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Celiac.com 06/04/2020 - Currently, in order to properly diagnose celiac disease based on serology and duodenal histology, doctors need patients to be on gluten-containing diets, even if they are causing symptoms, and this is called a "gluten challenge." This is a problem for many people, especially those who have already given up gluten, and see benefits from the gluten-free diet. For those people, going back on gluten for several weeks can be demoralizing. For many, it's a deal breaker. This can present challenges for doctors attempting to diagnose celiac disease. According to the University of Chicago Celiac Disease Center, a gluten challenge should be done as follows: Eat gluten prior to celiac disease blood tests: The amount and length of time can vary, but is somewhere between 2 slices of wheat bread daily for 6-8 weeks and 1/2 slice of wheat bread or 1 wheat cracker for 12 weeks 12 weeks; Eat gluten prior to the endoscopic biopsy procedure: 2 slices of wheat bread daily for at least 2 weeks; A Three Month Gluten Challenge May be Necessary, and the Length Can Differ Between Kids and Adults In a 2013 study by Maaike J. Bruins, of the DSM Biotechnology Center, The Netherlands, found that: Future Tests May Spot Celiac Disease Without Prolonged Gluten Consumption Research on systemic cytokine release that occurs after gluten sensitive individuals ingest gluten may lead to new tests that can spot celiac disease without gluten consumption, however, until further research is done, and such tests are developed and made available, a gluten challenge will be necessary to make a formal celiac disease diagnosis.
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Celiac.com 04/22/2023 - Celiac disease is an autoimmune disorder that may occur in genetically susceptible individuals. It is initiated by ingestion of gluten present in cereals, primarily wheat and to a much lesser extent other cereal proteins such as prolamines of barley and rye. Celiac disease is characterized by malabsorption resulting from inflammatory injury to the small intestinal mucosa. The classical symptoms of celiac disease include diarrhea, weight loss and malnutrition, however, only a small percentage of patients with celiac disease present with classical symptoms. Such patients represent the tip of the iceberg of gluten sensitivity. Many patients with celiac disease may present with short stature, iron and folate deficiency, anemia, bone loss, aphthous stomatitis, arthralgia, and dental enamel defects. Because of the varying and mild clinical presentations, celiac disease is often diagnosed when the patient has grown to adulthood rather than as a child. Adults may present with iron deficiency, anemia, macrocytic anemia and hypocalcemia. /* DivTable.com */ .divTable{ display: table; width: 100%; } .divTableRow { display: table-row; } .divTableHeading { background-color: #EEE; display: table-header-group; } .divTableCell, .divTableHead { border: 1px solid #999999; display: table-cell; padding: 3px 10px; } .divTableHeading { background-color: #EEE; display: table-header-group; font-weight: bold; } .divTableFoot { background-color: #EEE; display: table-footer-group; font-weight: bold; } .divTableBody { display: table-row-group; } Clinical Presentations of Celiac Disease Classical Features Atypical Chronic Diarrhea Iron-deficiency anemia Failure to thrive Dental enamel defecs Abdominal distension Short stature Osteoporosis/osteopenia Coexistence with other autoimmune disorders Diagnosis based solely on clinical criteria can be misleading and may lead to improper diagnosis and treatment as a result of the variety of clinical presentations often seen in other conditions. Problems with diagnosis has a serious impact on the patient. Delays in diagnosis commonly extend 10-13 years from the first presentation of clinical symptoms, leaving the patient subject to chronic symptoms while searching for proper diagnosis. Failure to diagnose this condition in the short term may predispose an individual to long term complications such as splenic atrophy and intestinal lymphoma. On the other hand, attempts to diagnosis a patient based primarily on clinical criteria may unnecessarily place the individuals on life long gluten-free diet as several transient conditions may mimic celiac disease clinically. /* DivTable.com */ .divTable{ display: table; width: 100%; } .divTableRow { display: table-row; } .divTableHeading { background-color: #EEE; display: table-header-group; } .divTableCell, .divTableHead { border: 1px solid #999999; display: table-cell; padding: 3px 10px; } .divTableHeading { background-color: #EEE; display: table-header-group; font-weight: bold; } .divTableFoot { background-color: #EEE; display: table-footer-group; font-weight: bold; } .divTableBody { display: table-row-group; } Cancer Morbidity on Normal, Reduced-Gluten and Gluten-Free Diet in Celiac Disease Diet Group Number Observed Malignancies Expected Malignancies Observed/ Expected Excess Morbidity Rate Normal 46 7 0.19 36.8 10.7 Reduced Gluten 56 5 0.12 41.7 5.0 Gluten-free 108 3 0.46 6.5 1.2 (Howelle PD, Is Coeliac Disease a Pre-Malignant Condition? Gastrointestinal Immunology and Gluten-Sensitive Disease, 1994. p.185) The true prevalence of celiac disease is difficult to ascertain. However, with the advent of serum antibody methods, incidences as high as one in 300 have been described in the general population, both in Western Europe and in the U.S. celiac disease is prevalent worldwide, but may be rare in individuals of Chinese and Japanese descent. /* DivTable.com */ .divTable{ display: table; width: 100%; } .divTableRow { display: table-row; } .divTableHeading { background-color: #EEE; display: table-header-group; } .divTableCell, .divTableHead { border: 1px solid #999999; display: table-cell; padding: 3px 10px; } .divTableHeading { background-color: #EEE; display: table-header-group; font-weight: bold; } .divTableFoot { background-color: #EEE; display: table-footer-group; font-weight: bold; } .divTableBody { display: table-row-group; } Prevalence of Celiac Disease Country Prevalence based upon Clinical Prevalence based upon Laboratory Finland 1:1000 1:330 Italy 1:1000 1:184 Germany 1:2300 1:500 Netherlands 1:4500 1:250 Denmark 1:10,000 1:330 USA 1:10,000 1:250 Guandalini S & Gupta P Clin appl Immun Rev 2:293-305, 2002 Historically, the diagnosis of celiac disease was based primarily on histological studies of the Jejunal biopsy characterized by villous atrophy, crypt hyperplasia, and lymphocytic and plasma cell infiltrate in the lamina propria. Histological examination of the small intestinal biopsy remains the gold standard for diagnosing celiac disease, but has its limitations. Many patients with celiac disease are small children and histological studies may be viewed by many, especially a child’s parents, to be a great discomfort. There may also be problems with accuracy. Occasionally, a biopsy with abnormally high density of intraepithelial lymphocytes with a normal villous architecture may be reported as normal. It has also been reported that some patients with latent or even active celiac disease show normal histopathology (Gastroenterlogy 104:1263-72, 1993). Celiac disease might also be confused with other disorders when diagnosed histologically. Parasitic infections (giardia lamblia) and malabsorption syndrome, for example, may mimic celiac disease histology. As these limitations have been recognized, serum antibody tests have gained acceptance in screening for celiac disease and in follow-up of patients with celiac disease to determine their compliance to a gluten-free diet. The various serological tests employed in the work-up of patients suspected to have celiac disease include anti-gliadin antibody (AGA), anti-endomysial antibody (EMA), anti-reticulin antibody (ARA) and anti-tissue transglutaminase (tTG) antibody tests. Antibodies to gliadin and tTG are detected by ELISA, whereas endomysium and reticulin antibodies are detected by indirect immunofluorescence. Of the serum antibody tests, EMA and tTG antibody primarily detects antibodies of IgA immunoglobulin isotype, whereas the AGA test detects both IgG and IgA isotypes. No IgM class antibodies to these antigens are detected in patients with celiac disease, hence there is no need to test for IgM class antibodies in the work-up of patients with celiac disease. Of these tests, AGA was the first to be described in the literature and has been evaluated most extensively. AGA of IgG are more sensitive but less specific then IgA-AGA. The major utility of IgGAGA is in celiac disease patients who are IgA deficient. In a study conducted recently in our laboratory, all of the 15 IgA-deficient celiac disease patients were found positive for IgG-AGA and negative for IgA-AGA and other autoantibodies (Celiac Disease and IgA deficiency: How effective are the serological methods of diagnosis? Clinical diagnostic lab Immunology 9:1295-1300, 2002). EMA and ARA are very specific indicators of celiac disease. These assays are immuno-histochemical methods and require experience in reading immunofluorescence reactions. Some investigators suggest that they are less sensitive. However, in all the studies conducted since our laboratory first described EMA back in 1983, we find the EMA assay to be 100% specific and sensitive for celiac disease. Other investigators may find EMA to be less sensitive due to the selection of the substrate, fixation of tissue sections, specificity of conjugate employed or serum screening dilution. Internally, we find that testing for EMA at dilutions of 1:2.5 or 1:5 yield 5% of patients positive for EMA yet negative at 1:10 or 1: 20. It could be that some of the investigators who have reported low sensitivity might be screening the patients at high serum dilutions. Since the identification of tTG as the endomyisal antigen, ELISA methods have been described for detecting antibodies in the sera of patients with celiac disease. The advantage of the anti-tTG antibody assay is that it is an automatable assay that is less subjective than EMA and it is more sensitive and specific than AGA. For these reasons, many laboratories have opted to use the tTG antibody method as the screening method. In these laboratories, it may be the only assay used for detection of celiac disease cases. In the majority of studies of the tTG antibody method, the specificity and sensitivity were found to be between 90-95%. Table 4 on page 15 summarizes the specificity of the AGA, EMA and tTG antibody methods most commonly employed by laboratories performing tests for celiac disease. /* DivTable.com */ .divTable{ display: table; width: 100%; } .divTableRow { display: table-row; } .divTableHeading { background-color: #EEE; display: table-header-group; } .divTableCell, .divTableHead { border: 1px solid #999999; display: table-cell; padding: 3px 10px; } .divTableHeading { background-color: #EEE; display: table-header-group; font-weight: bold; } .divTableFoot { background-color: #EEE; display: table-footer-group; font-weight: bold; } .divTableBody { display: table-row-group; } Diagnostic Specificity of Serological Markers for Celiac Disease Assay Specificity Sensitivity Anti-gliadin Antibody IgG 78% 88% Anti-gliadin Antibody IgA 86% 52% Anti-endomysial Antibody 100% 100% Anti-tissue transglutaminase 98% 90-95% If the prevalence of undiagnosed celiac disease is 4.8 per thousand as reported by Lagerqvist et al (J Intern Med 250:241-48, 2001) then of all the serological methods, EMA is the only method that provides 100% positive and negative predictive value for celiac disease. This raises the question of the optimum method of screening for celiac disease. The answer will vary according to the likelihood of celiac disease in the population studied and upon the experience of the laboratory performing the test. Some investigators may use the AGA or tTG antibody methods for screening and, if positive, confirm using the EMA test. We recommend this approach as it also helps to identify all celiac disease patients, whether IgA-deficient or not. Celiac disease patients are prescribed a gluten free diet for life. Serological tests are useful in monitoring a patient’s response and adherence to the gluten free diet. The levels of the various antibodies (AGA, EMA, ARA and tTG) decrease and eventually disappear in the majority of the patients on a complete gluten free diet. Similarly, these antibodies either appear or rise in level when the patient is on a gluten containing diet. Serological methods, therefore, play a significant role in both diagnosis and follow-up of celiac disease patients. Celiac disease has been associated with many other autoimmune disorders such as type 1 diabetes, thyroid autoimmunity and other autoimmune disorders. Approximately five percent of patients with type 1 diabetes have celiac disease. Similarly, approximately the same percentage of patients with celiac disease have type 1 diabetes. It has been proposed that early detection of celiac disease may be beneficial in such cases as it is believed that adherence to a gluten-free diet may delay the onset of diabetes. If true, this further emphasizes the utility of and need for serum antibody tests in the screening of population genetically susceptible for celiac disease. In conclusion, clinical symptoms of celiac disease are variable and often mild, resulting in significant delays in diagnosis. The use of serological tests has improved the ease of detection, monitoring, and hence— the continuing care of celiac disease patients.
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Celiac.com 02/05/2023 - If you have celiac disease symptoms, for example chronic diarrhea, anemia, bloating, abdominal pain, rashes, are in a higher risk group, etc., your doctor may order a blood test for celiac disease. Note that before doing any blood tests for celiac disease you must be eating gluten for a while beforehand, and the amount and length of time can vary, but is somewhere between 2 slices of wheat bread daily for 6-8 weeks and 1/2 slice of wheat bread or 1 wheat cracker for 12 weeks, otherwise you may end up with false negative results. For a celiac disease antibody test, a clinician collects a small amount of the patient's blood. The sample is then sent to a lab, where the blood cells are then removed, and the test is conducted. Celiac Disease Blood Tests Note that the accuracy and specificity of each test can vary depending on the laboratory performing the test, the specific method used, and the population being tested. Sensitivity refers to the ability of a test to correctly identify individuals with the condition (true positive rate), while specificity refers to the ability of a test to correctly identify individuals without the condition (true negative rate). tTG-IgA (tissue transglutaminase IgA) Blood Test for Celiac Disease This test measures the levels of IgA antibodies to tissue transglutaminase, an enzyme that is involved in the immune response to gluten in those who have celiac disease. The test is estimated to have a sensitivity of approximately 90%, which means that it correctly identifies 90% of people with celiac disease. It also has a high specificity of around 95%, which means that it correctly identifies 95% of people who do not have celiac disease. Other Names for the tTG-IgA Test: Tissue Transglutaminase IgA Test Anti-Tissue Transglutaminase IgA Test tTG-IgA Blood Test tTG-IgA Serology Test IgA-tTG Antibody Test Tissue Transglutaminase Antibody IgA Assay tTG-IgG (tissue transglutaminase IgG) Blood Test for Celiac Disease This test measures the levels of antibodies to tissue transglutaminase, but it specifically measures IgG antibodies rather than IgA antibodies which are produced in people who eat gluten and have celiac disease. It is not as sensitive or specific as the tTG-IgA test, but it may be useful in cases where a person has an IgA deficiency, which can occur in approximately 2-3% of people with celiac disease. In these cases, the tTG-IgG test may be positive while the tTG-IgA test is negative. However, the tTG-IgG test is not recommended as a first-line screening test for celiac disease. The sensitivity of the tTG-IgG blood test is generally high, ranging from 85% to 98%. This means that the test can accurately detect celiac disease in a significant percentage of people who have the condition. The specificity of the tTG-IgG blood test is also high, typically around 90% to 98%. This indicates that the test can effectively rule out celiac disease in individuals who do not have the condition. Other Names for the tTG-IgG Test: Tissue Transglutaminase IgG Test Anti-Tissue Transglutaminase IgG Test tTG-IgG Blood Test tTG-IgG Serology Test IgG-tTG Antibody Test Tissue Transglutaminase Antibody IgG Assay EMA-IgA (endomysial antibodies IgA) Blood Test for Celiac Disease This is a highly accurate test for celiac disease, that requires specialized expertise to perform and interpret, and it is more expensive than other blood tests. It is generally used as a last test to confirm celiac disease after a positive tTG-IgA test. The sensitivity of a test refers to its ability to correctly identify individuals with the condition. For the EMA-IgA blood test, the sensitivity is generally very high, ranging from 90% to 98%. This means that the test can accurately detect celiac disease in a significant percentage of people who have the condition. The specificity of a test refers to its ability to correctly identify individuals without the condition. For the EMA-IgA blood test, the specificity is also high, typically around 95% to 100%. This indicates that the test can effectively rule out celiac disease in individuals who do not have the condition. Other Names for the EMA-IgA Test: Endomysial Antibodies IgA Test Anti-Endomysium Antibodies IgA Test Endomysial Antibody IgA Assay EMA IgA Blood Test EMA-IgA Serology Test Endomysium IgA Ab DGP-IgA and DGP-IgG (Deamidated Gliadin Peptide) Blood Tests for Celiac Disease These tests measure the levels of antibodies in the blood, but specifically targets deamidated gliadin peptides, which are a type of gluten protein that can trigger an immune response in people with celiac disease. The tests are not always included in adults, but should be in cases with IgA deficiency. The tests should always be included when screening children, especially if they are under 2 years old. The DGP tests were created to detect celiac disease in those with IgA deficiency, and there are here is more information about them: DGP-IgA Test: This test measures the levels of IgA antibodies specific to deamidated gliadin peptide. IgA antibodies are produced by the immune system in response to gluten exposure. In individuals with celiac disease who produce normal levels of IgA, a positive DGP-IgA test result suggests the presence of ongoing immune response to gluten. DGP-IgG Test: The DGP-IgG test measures IgG antibodies against deamidated gliadin peptide. IgG antibodies are another type of immune response and may be elevated in individuals with celiac disease who have IgA deficiency (a common occurrence in celiac disease). The DGP-IgA test is considered to have high sensitivity and specificity. In general, the DGP-IgA test has been reported to have a sensitivity ranging from 75% to 95% and a specificity ranging from 90% to 100%. Overall, the DGP tests, including DGP-IgA and DGP-IgG, exhibit a sensitivity of approximately 85-95% and a specificity of about 95-98%. Other Names for the DGP-IgA Test: Gliadin Peptide Antibody IgG (Immunoglobulin A) Anti-Gliadin Antibody IgA (AGA IgA) Anti-Gliadin IgA Antibody (AGA IgA) Anti-Gliadin IgA (AGA IgA) Anti-Gliadin Immunoglobulin A Antibody (AGA IgA) Anti-Deamidated Gliadin Peptide IgA (DGP IgA) Anti-Deamidated Gliadin Antibody IgA (DGP IgA) The sensitivity of the DGP-IgG test is reported to range from 75% to 85%, which means it can correctly identify individuals with the condition in about 75% to 85% of cases. The specificity of the DGP-IgG test is reported to range from 75% to 95%, which means it can correctly identify individuals without the condition in about 75% to 95% of cases. Overall, the DGP tests, including DGP-IgA and DGP-IgG, exhibit a sensitivity of approximately 85-95% and a specificity of about 95-98%. Other Names for the DGP-IgG Test: Gliadin Peptide Antibody IgG (Immunoglobulin G) Anti-Gliadin Antibody IgG (AGA IgG) Anti-Gliadin IgG Antibody (AGA IgG) Anti-Gliadin IgG (AGA IgG) Anti-Gliadin Immunoglobulin G Antibody (AGA IgG) Anti-Deamidated Gliadin Peptide IgG (DGP IgG) Anti-Deamidated Gliadin Antibody IgG (DGP IgG) IgA Levels/Deficiency Blood Test This should always be included in any blood panel for celiac disease, but it does not test directly for celiac disease, and is done to determine the accuracy of the other blood tests. People who are IgA deficient may score lower, of have no measurable levels on certain celiac disease blood tests. This test measures the levels of Immunoglobulin A (IgA) in the bloodstream. IgA is an important antibody that plays a significant role in the immune system, particularly in protecting the body's mucosal surfaces (e.g., respiratory and digestive tracts). Low IgA levels can indicate IgA deficiency, a condition where the body does not produce enough IgA, leading to an increased risk of infections and other health issues. The IgA Levels/Deficiency Test helps healthcare providers diagnose and monitor IgA-related conditions. Other Names for the IgA Levels/Deficiency Test: Immunoglobulin A (IgA) Test Total IgA Test Serum IgA Test IgA Serum Levels Test IgA Blood Test IgA Quantitative Test IgA Antibody Test IgA Immunodeficiency Test Celiac Disease Blood Antibody Screening is ~98% Accurate in Adults Using the Mayo Clinic Protocol A celiac disease blood panel includes several tests to determine whether someone has celiac disease. These tests are very specific because certain antibodies only appear in those with gluten sensitivity, celiac disease and/or dermatitis herpetiformis. Testing begins with a test called Immunoglobulin A (IgA). If the results are normal, then a Tissue transglutaminase, antibody, IgA test is given. A weak positive should lead to the following tests: Endomysial antibodies (IgA) and; Gliadin (deamidated) antibody, IgA. If the initial Immunoglobulin A (IgA) test is lower than normal, then these two tests should be done: Tissue transglutaminase antibodies, IgA and IgG profle. Gliadin (deamidated) antibodies evaluation, IgG and IgA. If the initial Immunoglobulin A (IgA) test is below the level of detection (<1.0 mg/dL), then these two tests should be done: Tissue transglutaminase (tTG) antibody, IgG. Gliadin (deamidated) antibody, IgG. It sounds complicated, but it's pretty standard procedure now, and when blood screening is done this way the results for celiac disease are ~98% accurate. Many People Can Be Diagnosed Using Only Blood Tests and No Biopsy According to the latest research, if the blood test results are at certain high levels that range between 5-10 times the reference range for a positive celiac disease diagnosis, it may not be necessary to confirm the results using an endoscopy/biopsy: Blood Test Alone Can Diagnose Celiac Disease in Most Children and Adults TGA-IgA at or Above Five Times Normal Limit in Kids Indicates Celiac Disease in Nearly All Cases No More Biopsies to Diagnose Celiac Disease in Children! Biopsy Still Standard in Adult Celiac Diagnosis After positive blood tests some doctors still require a biopsy to confirm the diagnosis. However, this is changing, as new techniques allow doctors to accurately detect celiac disease in adults without a biopsy. Remember, nearly all tests and screening for celiac disease require the patient to be eating a gluten-containing diet before testing, usually you should be eating at least 1/2 slice of wheat bread or 1 wheat cracker daily for at least 2 weeks before the endoscopy. Be sure to check with your doctor for the latest protocol. Blood Tests for Follow Up Care Blood tests may also be useful in follow up care in those with celiac disease to confirm that their diet is indeed free of gluten. Also, because of the lack of standardization, keep in mind that blood test results may not be directly comparable from one lab to the next. More Celiac Disease Testing Resources What is a Gluten Challenge and How Long Must it Last? Interpretation of Celiac Disease Blood Test Results Ten Facts About Celiac Disease Genetic Testing Blood Test Questions on the Celiac Disease and Gluten-Free Forum Test results and question about gluten challenge How Long To Eat Gluten For Accurate Blood Test Read more at mayocliniclabs.com
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Celiac.com 06/06/2022 - Researchers have shown that tissue-transglutaminase antibodies (TGA) can be used to diagnose celiac disease without biopsy, but there's no good data on how accurate it is in real life conditions. A team of researchers recently set out to investigate real-life performance of a Bioplex2200 automated celiac serology analyzer, and to explore the correlation between tissue-transglutaminase antibody levels and intestinal biopsies in children. The research team included Anat Guz-Mark; Michal Kori; Chani Topf-Olivestone; Ronit Weinberger; Sara Morgenstern; Nadya Ziv-Sokolovskaya; and Raanan Shamir. They are variously affiliated with the Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel, Petach Tikva; the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv; the Pediatric Gastroenterology, Kaplan Medical Center, Rehovot; the Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem; the Immunology Laboratory, Clalit Health Services, Tel Aviv; the Institute of Pathology, Rabin Medical Center, Pitach-Tikva; and the Institute of Pathology, Kaplan Medical Center, Rehovot, Israel. The team conducted a retrospective review in two pediatric gastroenterological centers, between November 1, 2018 and April 1, 2020. They included patients with both tissue-transglutaminase antibody serology testing and duodenal biopsies. They gathered data including patient demographics, medical background, TGA levels, and biopsy results. In all, the team looked at 538 children. They found 256 with positive tissue-transglutaminase antibodies, and 282 with negative tissue-transglutaminase antibodies. Among patients with positive tissue-transglutaminase antibodies, intestinal biopsies confirmed celiac disease in 219, or nearly 86% of cases. The team found positive serology with normal histology in about fifteen percent of the cases. In more than half, they found tissue-transglutaminase antibody ranges of 1 to 3 times upper limit of normal. About twenty percent had tissue-transglutaminase antibody ranges 3 to 5 times upper limit of normal; about twenty percent had tissue-transglutaminase antibody ranges 5 to 10 times upper limit of normal; and just over 4% had tissue-transglutaminase antibody ranges above 10 times upper limit of normal, respectively. Nearly eighty-five percent of patients with positive tissue-transglutaminase antibodies also had positive anti-endomysial antibodies. However, overall diagnostic performance in these patients was inferior. The team found that the Multiplex tissue-transglutaminase antibody assay accurately diagnosed celiac disease in real world conditions. EMA screening did not improve the diagnostic accuracy in patients with positive tissue-transglutaminase antibodies. Meanwhile, false-positives varied depending on tissue-transglutaminase antibody range, but were low in patients with tissue-transglutaminase antibody levels above 10 times upper limit of normal. The ability to use multiplex tissue-transglutaminase antibodies for accurate celiac diagnosis offers clinicians another cheap and easy tool for catching celiac disease early. The easier and cheaper it becomes to diagnose celiac disease, and the earlier it can be caught, the more long term damage can be avoided for celiac sufferers. Read more in the Journal of Pediatric Gastroenterology and Nutrition
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Hello there all! I am new to the forum. I am so frustrated. First, I am already on a naturally gluten-free diet for Interstitial Cystitis. Anything wheat ticks off my entire system. Having major bowel issues the last 5 + weeks and for years really and pain in my gut for a while I was referred to GI. So they did every test in the book it seems, but me being completely Celiac unaware I didn’t know to press on certain aspects… for example many tests say results can be wrong on gluten-free diet … mind you I am not complaining if I am not celiac, etc … what I am saying is I feel like my doctor dispute me telling him I was on gluten-free diet he didn’t pick up on that and ran all these tests which are highly inaccurate in many ways if he is really testing for celiac. He told me … AND I QUOTE: ‘well, there is always hidden gluten… the tests are fine’ … um, I cook all my own food, I eat eggs, veggies, fruit, whole protein, herbs, spices… I have food allergies, too so I’m super limited. I can’t eat dressings or acidic foods, sauces, etc … unless I know what’s in them because I make them. anyways, I feel defeated that I am paying all this money for testing, I’m feeling like crap, and results with no gluten challenge there are faulty. mind you, me eating wheat products for two weeks with my bladder will be hell on wheels, but it leaves the question, is that really my bladder or is it my gut? I just want accurate tests… my Calprotectin came back <5 mcg … I should do cartwheels but it’s now leaving me with so many questions. I mean my tests should having me do flips cheering but I still feel defeated. has anyone else here experienced something similar? How did you deal with the doctor to get the testing redone?
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Tests: (1) TISSUE TRANSGLUTAMINASE ANTIBODY, IGG,IGA (11073) TISSUE TRANSGLUTAMINASE AB, IGG <1.0 U/mL TISSUE TRANSGLUTAMINASE AB, IGA <1.0 U/mL Tests: (2) IMMUNOGLOBULIN A (539) IMMUNOGLOBULIN A 281 mg/dL Tests: (3) ENDOMYSIAL ANTIBODY SCR (IGA) W/REFL TO TITER (15064) ENDOMYSIAL ANTIBODY SCR (IGA) W/REFL TO TITER NEGATIVE NEGATIVE I understand it’s a negative test and it’s not diagnostic with just this test alone but I was wondering if anyone could give me any insight into the numbers and what they mean? I have had all of the symptoms of celiac for several years now including DH.
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Celiac.com 11/25/2010 - Are you are interested in getting tested for celiac disease but would like to use an affordable and reliable company—perhaps one that even offers the option of confidential celiac disease blood screening? If your answer is yes to any part of this question I would highly recommend ClickMDLab.com. ClickMDLab.com is an online company that offers celiac disease testing via certified LabCorp laboratories, which are conveniently located throughout the USA. ClickMDLab.com offers a confidential screening service that allows you to completely bypass a trip to your doctor’s office—which means that your test results will not end up in your medical records (should you choose this option). My sister recently used their service to be screened for celiac disease via their celiac disease complete panel blood test. Within a few days my sister received her results via e-mail, and she didn't have to deal with a trip to the doctor's office and long wait times associated with the normal screening process. Her results were well-documented and easy to read, and on top of this the staff at CickMDLab.com were available and willing to assist her with any additional questions that she had. My sister had a wonderful first-time experience and we feel it's necessary to spread the word about this great new service.
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I recently went to the Gastroenterologist who told me something about possibly having celiac disease something about my upper GI I had in 2016 of there being a small trace of something that could indicate celiac disease. Anyway, he sent me for blood work and everything came back normal, except my glucose was slightly elevated at 103 other than that CMP and CBC was normal and my lipase serum was 54 u/l so could I still have Celiac Disease?
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Celiac.com 09/01/2015 - Current medical guidelines recommend routine screening of liver function tests (LFTs) in patients diagnosed with celiac disease. However, there isn't much good data on rates of liver disorders in celiac disease outside of Europe. A team of researchers recently set out to accurately estimate rates of LFT abnormalities in celiac disease in the USA, and to assess the effect of a gluten-free diet on LFTs. The research team included Natalia E Castillo, Rohini R Vanga, Thimmaiah G Theethira, Alberto Rubio-Tapia, Joseph A Murray, Javier Villafuerte, Alan Bonder, Rupa Mukherjee, Joshua Hansen, Melinda Dennis, Ciaran P Kelly and Daniel A Leffler. To identify adult patients with biopsy-proven celiac disease, they used a prospectively maintained database, which they matched with healthy controls. They defined abnormal LFT levels for women and men based on the Third National Health and Nutrition Examination Survey (NHANES III) criteria. The team gathered data on demographics, coexisting liver diseases, and laboratory work-ups including aspartate transaminase (AST) and alanine transaminase (ALT) values at the time of diagnosis and on a gluten-free diet. They later compared data from this group with data from 7,789 individuals participating in the National Health and Nutrition Examination Survey, 2009–2010, and applied univariate logistic regression, Wilcox on signed-ranks, Student's t-test, χ2, and Fischer's exact test for statistical analysis. In 463 celiac disease patients with ALT or AST levels at the time of celiac disease diagnosis, 40.6% had elevated LFTs compared with 24.2% of treated celiac disease patients (P<0.001). Similarly, nearly forty percent of celiac disease patients on the NHANES database showed abnormal ALT values compared with less than twenty percent of non-celiac patients (P=0.03). Just over forty percent of individuals will show elevated LFTs at celiac disease diagnosis, but the vast majority, nearly eighty percent of those patients will show normal LFTs within a year and a half of adopting a gluten-free diet. The team suggests that doctors check all celiac patients for LFTs, and coexisting liver disorder be considered in patients whose LFTs have not improved within a year on a gluten-free diet. Source: The American Journal of Gastroenterology 110, 1216-1222 (August 2015). doi:10.1038/ajg.2015.192
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Hello all! Lab results came in and of course Dr not available until next week. I did some research but so many sites with so much information, and I am feeling overwhelmed. Here are the results: Immunoglobulin A, Qn, Serum 156NORMAL t-Transglutaminase (tTG) IgA 6HIGH Endomysial Antibody IgA Positive Thank you in advance for any input and guidance!
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Hi all, I'm new to the forum so I'm really hoping someone will be able to help. I've been having digestive issues for the past 2 years and have lost nearly 4 stone in weight. All of my symptoms suggest celiac disease, I not only have digestive issues, bloating ect but my upper arms are covered in a rash, obviously the weight loss and then I'm also constantly anaemia and I now have low vitamin D levels along with depresssion, anxiety, constant headaches, tiredness, stomach pain ect. I know these symptoms could suggest a number of issues but I have noticed once I've stopped eating gluten products my symptoms seem to at least lessen. I've asked the doctor what he suggests and he does think it is likely but i'm struggling to be put forward for further testing. I'va had countless generic blood tests but obviously this isn't enough to diagnose if I have it or not. I'm honestly losing my mind with not only feeling so ill but also not knowing what exactly is wrong with me. Should I just try a gluten free diet and see if my symptoms continue to improve or what?
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Celiac.com 02/01/2018 - To make a clinical diagnosis of celiac disease, doctors use serological testing for IgA antibodies to human tissue transglutaminase (anti-tTG) which indicate celiac disease autoimmunity. However, some tests are more highly sensitive for anti-tTG, while other tests are highly specific. So, is combining two tests a reliable strategy for screening for celiac disease in clinical practice? A team of researchers recently compared the performance of three kits used to diagnose celiac disease, and evaluated the point prevalence of celiac disease autoimmunity in a South Indian urban population. The research team included G Venugopal, J Mechenro, G Makharia, A Singh, S Pugazhendhi, R Balamurugan, and BS Ramakrishna. They are variously associated with the SRM Institutes for Medical Science, Jawaharlal Nehru Salai, Vadapalani in Chennai, India, the SRM Medical College Hospital and Research Centre, Kattankulathur, India, the All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India, the Kansas University Medical Center, Kansas City KS, USA, the Indian Institute of Technology, Samantapuri, Bhubaneswar, India, the SRM Institutes for Medical Science, Jawaharlal Nehru Salai, Vadapalani, Chennai, India, and with the SRM Medical College Hospital and Research Centre, Kattankulathur, India. For the first part of their study, the team performed anti-tTG testing on sera from 90 patients with documented celiac disease and 92 healthy controls using three different kits. They then tested one thousand nine hundred and seventeen healthy adults residents of the Vellore and Kancheepuram districts for celiac disease autoimmunity using a sequential two-test strategy. Based on these results, the team suggests that using first a highly sensitive test for anti-tTG followed by a highly specific test is a reliable strategy for screening for celiac disease in clinical practice. Source: Indian J Gastroenterol. 2017 Dec 22. doi: 10.1007/s12664-017-0803-z.
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Celiac.com 09/11/2017 - The FDA has granted clearance for Immco Diagnostics' ELISA for celiac disease, and for Roche's Benchtop Analyzer. What does that mean? Immco's test is conducted as a solid phase immunoassay and is intended for the qualitative or semiquantitative detection of IgA or IgG antigliadin antibodies in human blood, and thus to aid in diagnosing patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings. In other important diagnostic news, a benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical was among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency. The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument platform, as well as the Cobas HbA1c test. The fully automated and self-contained Cobas b 101 uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA. The Cobas HbA1c is an in vitro diagnostic test for detecting the presence of glycate hemoglobin, which develops when hemoglobin joins with glucose in the blood, becoming 'glycated'. By measuring glycated hemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. The HbA1c assay is designed for use with the Cobas b 101 platform, which is not a portable home test, but is intended for a clinical laboratory or point-of-care setting. Other instruments receiving FDA clearance in July include a new flow cytometer from Becton Dickinson; an expanded version of Bruker's MALDI Biotyper; and expanded indications for BioMérieux's Vitek MS MALDI-TOF Mass Spectrometery System. The FDA recently cleared the Maglumi 2000 automated immunoassay analyzer from Shenzhen New Industries Biomedical, which uses chemiluminescent technology for running IVD tests on clinical serum samples. The firm's Maglumi 2000 TSH assay for the quantitative determination of thyroid-stimulating hormone in human serum also received 510(k) clearance. The assay is for diagnosing thyroid disorders. These are just a few of many new tests and analysis devices that are changing the way doctors diagnose and manage celiac disease, diabetes, and other diseases. Look for tests like this to have a profound influence on the way diseases are diagnosed and managed in the future. Read more: 360dx.com
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Celiac.com 08/21/2017 - Can a tiny Virginia start-up change the world with a cheap, reliable devise to test food for gluten on the fly? With their startup called Altede, Ed and Anna Champion, together with business partner Briana Petruzzi, hope to build quick, cheap tests for all sorts of food allergens. Their first target is gluten. Altede is looking to develop a test that is reliable, sensitive to FDA levels of 20ppm gluten, costs less than $5 and could be performed within a couple of minutes while sitting at a restaurant table. The Altede team doesn't expect anyone to test everything they eat. But those with severe gluten intolerance might find peace of mind in a pinch. "We really want to keep the cost low. We think that's going to be critical," says Ed Champion. "You know, $15 and you're not going to do it. It's going to be too painful. But $3 or $5…what's your afternoon worth?" Altede has developed an antibody that they grow inside of and later extract from mice, a technique also used by pregnancy test manufacturers. The antibody is specially engineered to latch onto protein molecules inside gluten. A user like Anna Champion would carry the kit, which is about the size of a pack of M&M's. When she comes across a food she wants to eat but suspects may make her sick, she puts a pea-sized sample into a liquid container that comes inside the pouch. She would shake it up and then dip the test strip. The liquid would creep along the paper, passing a stripe of the antibodies Altede designed. If gluten is present, the antibodies will latch on to the proteins, accumulate on the paper and produce a visible pink line. So far, their prototype device can detect small amounts of gluten. The prototype looks and operates just like a pregnancy test. But the test currently takes hours, instead of minutes. Ed Champion says that tweaks to the chemistry will provide quicker results, though there are still a number of technical challenges to overcome. But after two years of development, Champion says the team is getting close. To help the, prepare their portable gluten tester for a product launch, Altede recently enrolled in the first cohort of RAMP, Roanoke's business accelerator, and received a $50,000 grant from the state's Commonwealth Research Commercialization Fund. Once the company can quickly and reliably test for gluten, it will use the same technology to build tests for a number of different food allergens. Champion has invested more than $30,000 in the venture to date. He supplies the business knowledge for the company, while Anna Champion, a Virginia Tech researcher, and Petruzzi, a Ph.D. student, are the scientific brains behind the operation. Stay tuned for updates on Altede and their efforts to build a better gluten test.
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Celiac.com 06/28/2017 - Tests to measure serum endomysial antibodies (EMA) and antibodies to tissue transglutaminase (tTG) were developed to screen for celiac disease in patients who are actively eating gluten. However, doctors often use them to monitor patients on a gluten-free diet. Now, making sure celiac patients are successfully following a gluten-free diet is important, as unconscious gluten ingestion can lead to complications over time. But how accurate are these tests for assessing gluten-free compliance in celiac patients? A team of researchers recently set out to assess the sensitivity and specificity of tTG IgA and EMA IgA assays in identifying patients with celiac disease who have persistent villous atrophy despite a gluten-free diet. The research team included Jocelyn A. Silvester, Satya Kurada, Andrea Szwajcer, Ciarán P. Kelly, Daniel A. Leffler, and Donald R. Duerksen. They are variously affiliated with the Farncombe Family Digestive Health Research Institute and Division of Gastroenterology, and the Department of Pathology and Molecular Medicine and Department of Medicine, McMaster University, Hamilton, Ontario. To begin their meta-analysis, the team searched PUBMED, EMBASE, BIOSIS, SCOPUS, clinicaltrials.gov, Science Citation Index, and Cochrane Library databases through November 2016. They included studies of subjects with biopsy-confirmed celiac disease, follow-up biopsies and measurement of serum antibodies on a gluten-free diet, biopsy performed on subjects regardless of symptoms or antibody test results. Their analysis excluded patients with refractory celiac disease, undergoing gluten challenge, or consuming a prescribed oats-containing gluten-free diet. They determined positive or negative findings based on manufacturer cut-off values. They defined villous atrophy a Marsh 3 lesion or villous height:crypt depth ratio below 3.0. They constructed forest plots to determine the sensitivity and specificity of detection for individual studies. For their meta-analysis, they used a bivariate random effects model to determine both sensitivity and specificity. Their search of abstracts revealed 5,408 unique citations, which yielded 442 articles for detailed review. Those reviewed articles yielded just 26 studies that met the team’s inclusion criteria (6 of tTG assays, 15 of EMA assays, and 5 of tTG and EMA assays). Inability to cross-tabulate histologic and serologic findings was the most common reason the team excluded a given study from analysis. They found that serum assays identified patients with persistent villous atrophy with high levels of specificity: 0.83 for the tTG IgA assay (95% CI, 0.79–0.87) and 0.91 for the EMA IgA assay (95% CI, 0.87–0.94). However, the tests showed low sensitivity for detecting villous atrophy: 0.50 for the tTG IgA assay (95% CI, 0.41–0.60) and 0.45 for the EMA IgA assay (95% CI, 0.34-0.57). Results were similar in both pediatric and adult patients. A meta-analysis of biopsy-confirmed celiac patients who received follow-up biopsy while on a gluten-free diet, showed that tests for serum tTG IgA and EMA IgA had low sensitivity, detecting persistent villous atrophy less than 50 percent of the time. The team supports the search for more accurate, non-invasive, markers of mucosal damage in celiac patients who follow a gluten-free diet. Source: Gastroenterology. DOI: http://dx.doi.org/10.1053/j.gastro.2017.05.015
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Celiac.com 02/17/2017 - In recent tests, researchers found that microwave treatment (MWT) of wet wheat kernels caused a striking reduction in R5-antibody-based ELISA gluten readings, reducing the readings to under 20 ppm, so that wheat could theoretically be labeled as gluten-free. However, the actual gluten content of the wheat remained unchanged. Just the test reading changed. The research team included C Gianfrani, G Mamone, B la Gatta, A Camarca, L Di Stasio, F Maurano, S Picascia, V Capozzi, G Perna, G Picariello, A Di Luccia. They are variously affiliated with the Institute of Protein Biochemistry, CNR, Naples, Italy, the Institute of Food Sciences, CNR Avellino, Italy, the Department of the Sciences of Agriculture, Food and Environment at the University of Foggia, Italy, the Institute of Food Sciences, CNR Avellino, Italy; Department of Agriculture, University of Naples, Portici (Na), Italy, the Department of Clinical and Experimental Medicine, University of Foggia, Foggia (Italy) and National Institute of Nuclear Physics, Section of Bari, Italy, and the Department of the Sciences of Agriculture, Food and Environment, University of Foggia, Italy. The failure of R5 Elisa to register gluten in MWT stands in stark contrast to analysis of gluten peptides by G12 antibody-based ELISA, mass spectrometry-based proteomics, and in vitro assay with T cells of celiac subjects, all three of which gave consistent results both before and after MWT. As to what caused the R5 Elisa to misread the MWT samples, an SDS-PAGE analysis and Raman spectroscopy showed that MWT reduced the alcohol solubility of gliadins, and altered the access of R5-antibody to the gluten epitopes. Thus, MWT neither destroys gluten nor modifies chemically the toxic epitopes, this contradicts claims that MWT of wheat kernels detoxifies gluten. This study provides evidence that R5-antibody ELISA alone is not effective to determine gluten levels in thermally treated wheat products. Gluten epitopes in processed wheat should be monitored using strategies based on combined immunoassays with T cells from celiacs, G12-antibody ELISA after proteolysis and proper molecular characterization. Source: Food Chem Toxicol. 2017 Jan 12;101:105-113. doi: 10.1016/j.fct.2017.01.010.
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Celiac.com 12/24/2015 - Laboratory tests for hemoglobin, ferritin, calcium, folate, vitamin B12, vitamin D, and thyroid function are regularly ordered in children with celiac disease, despite sufficient evidence for their necessity. To determine the frequency of nutritional deficiencies and levels of thyroid dysfunction in children with celiac disease, researches conducted a study that examined children before and after the initiation of a gluten-free diet. The research team included Margaretha Maria Susanna Wessels, MD, Iris I. van Veen, MD, Sabine Lisa Vriezinga, MD, Hein Putter, PhD, Edmond Henri Herman Maria Rings, MD, PhD, and Maria Luisa Mearin, MD, PhD. They are affiliated with the Department of Pediatrics, Department of Statistics, and the Department of Pediatrics, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands. For their study, the team evaluated test results for hemoglobin, ferritin, folate, vitamin B12, calcium, vitamin D (25[OH]D), free thyroxin, and thyroid stimulating hormone of children with celiac disease regularly seen at the Leiden University Medical Center between 2009 and 2014. The team used laboratory reference ranges to define abnormal results. For statistical analysis, they used Pearson χ2 test for trend, unpaired t test, and 1-way ANOVA. Their results for 182 children evaluated, showed 119 were newly diagnosed. About 17% of results were missing for any given year, due to incomplete blood results. The most common deficiencies at the time of celiac diagnosis were iron deficiency, found in 28% of celiac patients, vitamin D deficiencies in 27%, and folate deficiency, in 14%. They also saw iron deficiency anemia in 9%, and vitamin B12 deficiency in 1% of celiac patients. They saw no hypocalcemia or thyroid dysfunction. At follow-up, they observed iron deficiency, iron deficiency anemia, and folate and vitamin D deficiency 8%, 2%, 3%, and 25% of patients, respectively. They found no vitamin B12 deficiency, hypocalcemia, and thyroid disease. From these results, the team concluded that complementary blood investigations are relevant at the time of celiac diagnosis, but have little follow-up use, once the patients adopt a gluten-free diet. They recommend that such tests be conducted only if there is a clear physical issue, such as fatigue or abnormal growth. Source: Journal of Pediatrics. DOI: http://dx.doi.org/10.1016/j.jpeds.2015.09.078
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Celiac.com 09/08/2011 - What started in January as a quiet and limited campaign by Subway to test gluten-free rolls and brownies in the Dallas market, then spread to a few Portland outlets, has rapidly grown into a plan to include more than 500 stores. So far, Subway has been "very pleased" with its tests, and has gotten an "overwhelmingly positive" response from customers. Customers have deluged Subway with requests for a wider roll out, but the company remains committed to getting the process right from R&D to supply to in-store training, all with an eye toward customer satisfaction, says Mark Christiano, Subway's Baking Specialist in the R&D Department. To Subway's credit, they are eager to meet their customers' demands, but cautious to get the entire process right. From product quality to preparation and customer satisfaction, Subway seems committed to getting it right. Subway does plan to expand both the gluten-free tests, and, eventually, incorporate gluten-free options into their menus, but the process will be slow and meticulous, according to Christiano. "We will take our time with this and make sure we deliver these products to the consumer the right way. If it was easy to do, everyone would have gluten-free available. Obviously it's not," he said. Still, rolling out gluten-free bread represents a huge opportunity for Subway. The National Restaurant Association listed gluten-free among the top five culinary themes for 2011. A majority of that market growth will come from the U.S. food service industry, which is expected to grow by more than $500 million by 2014. Even though customers may clamor for more gluten-free offerings, it is important that companies not just chase a dollar, but that they deliver quality gluten-free service that matches their gluten-free product. For their part, Subway is to be commended for putting such a serious amount of R&D into their gluten-free offerings. Their effort to provide both a quality product and to deliver that product consistently and with an eye toward customer satisfaction sets the bar for how to go about it. "(Gluten intolerance) doesn't impact a large mass of people. We're not judging these tests on sales, but instead on what we're able to do for a handful of our customers and their feedback," Kevin Kane, manager of public relations for Subway said. "It's not a money making thing; it's just the right thing to do." As Subway's efforts begin to pan out, look for more gluten-free offerings at your local outlet. Just the small trial of gluten-free rolls and brownies in Dallas offered logistical challenges. Christiano said the company spent about three years in development, followed by extensive training to make sure everyone was on board. The company went as far as working with an undisclosed supplier using a recently purchased gluten-free facility. Beyond the R&D and supply chain efforts to deliver quality raw materials, Subway has taken a great deal of time to design and implement a comprehensive in-store training program that will help them deliver a consistently high-quality and truly gluten-free "Having these items on the menu changes the entire way of doing things. It needs to be taken very seriously. The methods of handling this food have to be followed to a T," Christiano said. This includes extensive instructions, presentations and demonstrations, as well as monthly meetings to reinforce the process. Under Subway's new guidelines, whenever a customer orders a gluten-free roll or brownie, the line staff will wipe down the entire counter of any crumbs. They will then wash their hands and change their gloves. The gluten-free rolls and brownies are pre-packaged on fresh deli paper, and the staff use a single-use, pre-packaged knife for cutting. Each gluten-free sandwich will be made and delivered from order to point-of-sale by the same person, as opposed to being passed down the line in the traditional Subway format. Customers can watch the process from beginning to end. Most importantly, "If they don't like what they see, they can start it over. It's important that our customers feel comfortable and safe," Christiano said. "Nobody is going to die from this, but people get very sick if it's not done right. We want to provide them with a place to eat where they don't have to worry about that." Rather than just jumping on the gluten-free band-wagon, it sounds like Subway has committed to delivering a quality gluten-free experience from start to finish. Stay tuned to learn about their ongoing gluten-free product trials and their efforts to expand those offerings throughout their chain. Source: http://www.qsrweb.com/article/183399/Subway-expands-gluten-free-test
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Celiac.com 08/26/2015 - People with IgA antibodies to tissue transglutaminase (anti-tTg) likely have a higher risk for celiac disease. Some clinicians and researchers have suggested that common multiples of the upper limit of normal (ULN) be useful tool in improving diagnostic pathways, as well as continuity between tests. However, a new study suggests that both sensitivity and specificity of tests for IgA antibodies to tissue transglutaminase vary widely by individual kit, and that their test values are not easily commutable using common multiples of the ULN to correct for inter-assay variations. Commutability just means the ability to make sure that two different tests really are equal. If results of different tests are commutable, it means that they are equal. In this case, the term applies to test results for various representative samples from healthy and diseased individuals. For the study, the research team recently looked at the use of immunoassays for the detection of IgA antibodies to tissue transglutaminase, and also sought to better understand of the significance of multiples of the upper limit of normal and inter-assay correlations. The research team included B.B. Suh-Lailam, K.W. Davis, and A.E. Tebo. Using indirect immunofluorescence assay (IFA) as reference, the team assessed characteristics of four anti-tTG IgA assays relative to endomysial IgA (EMA). They also assessed commutability between anti-tTG immunoassays and/or EMA based on manufacturer's recommended cut-off values and three common multiples of ULN (3×, 5× and 10×). To do this, they analyzed samples from 200 patients and 100 healthy individuals. They found that, at manufacturer's cut-off, the sensitivities for the tTG assays ranged from 72.5% to 98.6% and specificities from 60.3% to 99.2%. The percent positive agreements between any anti-tTG and EMA or any two anti-tTG immunoassays varied from 56.7% to 98.0% and 46.7% to 100.0%, respectively. At 3×, 5× or 10× ULNs, the inter-rater reliability as measured by Cohen κ between any two anti-tTG assays were quite variable and ranged from 0.28 to 0.96, 0.26 to 0.89 or 0.13 to 0.78, respectively. Furthermore, the percent positive agreements between any two anti-tTg IgA immunoassays ranged from 83.1% to 98.2%, 92.0% to 100%, or 100%, at 3×, 5× or 10×, respectively. Hence, the team's basic takeaway that result parameters for tTG IgA immunoassays or tTG IgA and EMA vary by kit, and thus common multiples of the ULN are not enough to correct for variation between tests. Source: Clin Chem Lab Med. 2015 Jul 14. doi: 10.1515/cclm-2015-0348.
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Celiac.com 11/26/2012 - I speak to many people from across the country, and internationally, who contact me requesting help. The issues they face are summarized into three categories: individuals with celiac disease who do not have their disease under good control; those with gluten sensitivity who remain less than healthy despite their gluten-free diet; individuals, and this is a big one, who are convinced that they have a gluten problem, due to self experimentation, but who are unable to get any corroboration or support from their doctors. Having been immersed in this field for almost twenty years, it is frustrating not having a laboratory test that will reliably state whether someone has celiac disease or if gluten sensitivity has been ever present. The good news is that this situation has improved. It’s not perfect, but it’s better than it has been, and I wanted to share this data with you and those you care about. These newly available tests can have a big impact on those who need a diagnosis, as well as those who are already gluten-free but want to know why they are not enjoying the good health they desire. I have no affiliation with either of the labs I mention so there is no conflict of interest in my recommendations. The first lab, Cyrex Laboratories, is the newest lab specializing in gluten intolerance in the US. It currently offers four different profiles. There is a fifth one coming, hopefully very soon, that is also very exciting and a description of it follows. I will provide the data that the lab lists in their brochure for each test along with my personal opinion as to its benefit and use. Here at HealthNOW Medical Center we have been utilizing these tests for almost five months—the lab just opened in January after three years of research and passing governmental licensing requirements. Array 1: Gluten Sensitivity “This is a saliva test which is recommended for patients who: Are suspected of having mucosal abnormality Have relatives with celiac disease Have type 1 diabetes Have autoimmune thyroid disorder Have relatives with autoimmune disorders, especially, multiple sclerosis, diabetes and arthritis.” This is an easy screening test for those who wonder if they have gluten sensitivity or celiac disease based on their own symptoms or symptoms in their family. As a saliva test it’s very easy to perform (no blood draw is needed) and it’s the least expensive of all the tests offered. When utilizing saliva, a test is only as accurate as the strength of the salivary immune system. Due to this limitation, the lab also measures this as part of the panel. In the past, labs would not include this measurement, sometimes resulting in false negative results—something we all wish to avoid. Array 2: Intestinal Barrier Integrity Screen “Intestinal barrier integrity plays a vital role in the overall health and well-being of patients. This blood test is recommended for patients who: Have gut dysbiosis, which appears to be resistant to standard therapy Are suspected of having intestinal mucosal damage Complain of food allergy and intolerance Present multiple symptom complaints (including chronic fatigue syndrome) Suffer from abnormal immune cell count and function (including autoimmune diseases) May suffer from depression or neuroautoimmunity [including such conditions as: thyroid disease, arthritis, myocarditis, dermatitis, endocrinopathy, osteoarthritis and pernicious anemia] ” Healing a leaky gut is a very big part of regaining one’s health after a diagnosis of gluten intolerance. Gluten has caused damage to the lining of the small intestine and the presence of this damage is thought to be an initiator of the many “non-digestive” symptoms and diseases that are associated with gluten, including autoimmune disease. Prior to this test two substances have been traditionally used to measure a leaky gut: lactulose and mannitol. The disappointment of the test lay within the sensitivity, or I should say lack of sensitivity, to adequately diagnose subtle leakiness vs. gross leakiness such as that found in advanced celiac disease and complete villous atrophy. Much as an intestinal biopsy can miss the early and more subtle damage to the villi of the small intestine [its lining], so too does the lactulose/mannitol test seem to miss the more subtle changes in a leaky gut. This test will detect increased permeability through the cells that line the small intestine, as well as increased permeability between the cells. Clinically we use this test as a gauge of how we are progressing clinically rather than as a first tier diagnostic tool. There is no sense in measuring a leaky gut when it’s obviously there. But to prove that a clinical program is producing results or to perhaps show a less than compliant patient that their indiscretions are creating problem, this is an excellent test. Array 3: Comprehensive Gluten Sensitivity & Autoimmunity “To broaden the view of celiac disease and gluten sensitivity, our doctors can better diagnose the disorder by assessing antibody production against an array of protein, enzyme and peptide antigens. This blood test is recommended for patients who: Have gut dysbiosis—poor probiotic balance Are suspected of having intestinal mucosal damage—this means damage to the lining of the small intestine Complain of food allergies Complain of chemical hypersensitivity Present multiple symptom complaints (including chronic fatigue syndrome and Fibromyalgia) Suffer from abnormal immune cell count and function May suffer from depression or neuroautoimmunity [see below] Neuroautoimmune patients to consider: thyroid, arthritis, myocarditis, dermatitis, endocrinopathy, polyendocrinopathy, osteoarthritis and pernicious anemia” This panel is the broadly inclusive blood test designed to measure both celiac disease and gluten sensitivity. Because this test measures several aspects of the protein structure (rather than just the single protein fragment heretofore analyzed), we believe it will take many of the false negatives out of the picture—certainly a welcome change. Despite feeling better when removing gluten from their diets, patients like to confirm their own experience with a third party lab test. In the past, lab tests were so riddled with false negatives that we had to encourage patients not to discount their personal experience with a gluten-free diet, despite the absence of correlation with the lab test. This approach was not always successful and at times patients returned to gluten simply because they had no lab test to verify the truth. Inevitably they would return to us many months later, feeling worse than ever and ready to, once again, look at a gluten-free diet. This panel is more sensitive and specific than any we have had in the past, thereby reducing false negatives greatly. A patient does have to be consuming gluten for this profile to be accurate. Array 4: Gluten-Associated Cross-Reactive Foods Complete normalization of gut lesions is very rare in adult patients with celiac disease (8%), despite compliance with the gluten-free diet. This may be due to cross-reactions with an array of foods. This blood test is recommended for patients who: Have gluten sensitivity or celiac disease. Are non-responsive on a gluten-free diet—in other words don’t feel better. Have gut dysbiosis [not enough healthy bacteria and too many unhealthy ones], which appears to be resistant to standard therapy. Have an autoimmune disorder. This panel is very exciting and we are already seeing a dramatic impact on our patients. When one has eliminated gluten (and often dairy) from one’s diet, it obviously takes a big commitment. The last thing such a person might want to hear is that there are other foods they may also need to eliminate. Consider this: What if a temporary dietary change of eliminating foods that are confirmed as problematic on a laboratory test resulted in the difference between continued ill health and good health? Now, perhaps, it sounds like a good idea. That is exactly what we found in patients who were being extremely vigilant about their diet but still felt “glutenated” or just ill and the cause was not being found. Cross-reactive foods are foods with a protein structure similar to gluten’s that, upon ingestion, confuse one’s immune system into thinking that it has ingested gluten. The proteins are confused, one for another, and the reaction is as negative as if one has consumed gluten. This panel looks at twenty five possible foods (mostly in the grain and dairy families) to which one could be experiencing a cross-reactivity reaction. While it definitely takes a further commitment to confront more dietary change, our current patients consider it well worth it based on their health improvement. Finally, Array 5 that is not yet released, will focus on possible autoimmune reactions occurring from gluten. Autoimmune diseases can be “in the works” so to speak for well over a decade before the body experiences its first symptom. As the third leading cause of death in this country and with no known cure, any forewarning of autoimmune activity would be an excellent tool. This test provides another much needed tool for those patients who, although know they are gluten intolerant, cheat on their diet with seeming impunity—meaning they don’t feel any ill effects from having done so. Array 5 will be able to reveal what is occurring on a deeper level of the body such that the patient can see where gluten may be beginning to create autoimmune tendencies in certain organs or systems that he or she cannot feel. The second laboratory I want to mention is Enterolab. Although Enterolab is not new, they are unique. A few things make them different from all other labs I know about: You don’t have to work with a doctor to receive a lab test. Enterolab works directly with the patient on-line. They will send you a test kit after you have paid them and test results are emailed to the customer. Enterolab uses stool testing for their celiac and gluten sensitivity panels. They have a unique technology that allows them to test for these conditions even if the patient has not been eating gluten. They offer genetic testing as well as testing for other food intolerances. Once again, no doctor referral is required. I believe these tests offer benefit not only for those who need a diagnosis but also for those with a diagnosis who are not yet enjoying ideal health. I hope you found this informative. Please do feel free to contact me regarding any further questions that you may have. Our clinic, HealthNOW is a destination clinic and we treat patients from across the country as well as internationally. We are here to help. To your good health!
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Celiac.com 12/16/2013 - Numerous popular herbal products may be contaminated or may contain unlabeled substitute ingredients and fillers, meaning that they are not what their labels claim. According to the World Health Organization, adulterated herbal products are a potential threat to consumer safety. These revelations came to light after a group of Canadian researchers conducted an investigation into herbal product integrity and authenticity, with hopes of protecting consumers from health risks associated with product substitution and contamination. Using a test called DNA barcoding, a kind of genetic fingerprinting that been effective in uncovering labeling fraud in other commercial industries, the researchers found that nearly 60% of herbal products tested were not what their label claimed them to be, and that pills labeled as popular herbs were often diluted or replaced entirely, sometimes with cheap fillers that could be dangerous to consumers. In all, the researchers tested 44 herbal products from 12 companies, along with 30 different species of herbs, and 50 leaf samples collected from 42 herbal species. The researchers were Steven G. Newmaster, Meghan Grguric, Dhivya Shanmughanandhan, Sathishkumar Ramalingam and Subramanyam Ragupathy. They are variously affiliated with the Centre for Biodiversity Genomics, Biodiversity Institute of Ontario (BIO) at the University of Guelph, the Bachelor of Arts and Science Program at the University of Guelph in Guelph, Ontario, Canada, and with the Plant Genetic Engineering Laboratory, Department of Biotechnology, Bharathiar University in Tamil Nadu, India. Their laboratory also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples. The team recovered DNA barcodes from most herbal products (91%) and all leaf samples (100%), with 95% species resolution using a tiered approach (rbcL + ITS2). Nearly 60% of the products tested contained DNA barcodes from plant species not listed on the labels. That means they were not what the label said they were. Furthermore, even though 48% of the products contained authentic ingredients, one-third of those also contained contaminants and/or fillers not listed on the label. The air data showed clearly that most herbal products tested were not what their labels claim, while most of the rest were poor quality, and often contained unlabeled, possibly dangerous, product substitute, contamination and fillers. They note that selling weak, ineffective, or mislabeled herbal supplements reduces the perceived value of otherwise helpful products by eroding consumer confidence. The study team recommends that the herbal industry embrace DNA barcoding to ensure authentic herbal products by effectively documenting raw manufacturing materials. They suggest that the use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for 'best practices' in the manufacturing of herbal products, and note that this would provide consumers with safe, high quality herbal products. What do you think? Should herbal products and supplements be tested, authenticated and verified? Share your thoughts below. Source: BMC Medicine 2013, 11:222. doi:10.1186/1741-7015-11-222
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Celiac.com 06/27/2013 - Patients with villous atrophy and negative celiac disease serologies pose a diagnostic and therapeutic dilemma. When doctors are unable to determine what is causing villous atrophy in a patient without celiac disease, they usually classify it as a case of "unclassified sprue." However, doctors currently know very little about the best way to treat and manage cases of unclassified sprue. To get a better picture of this dilemma, a team of researchers recently examined the connections between villous atrophy and negative celiac serology. The research team included M. Degaetani, C.A. Tennyson, B. Lebwohl, S.K. Lewis, H. Abu Daya, C. Arguelles-Grande, G. Bhagat G, and P.H. Green. They are variously affiliated with the Celiac Disease Center, and the Department of Medicine at Columbia University College of Physicians and Surgeons at Columbia University Medical Center in New York, USA. For their study, the team looked at adult patients with biopsy-proven villous atrophy and negative celiac serology, evaluated at our tertiary referral center over a 10-year period. They noted test results for HLA DQ2/8 alleles, antienterocyte antibodies, giardia stool antigen, bacterial overgrowth, total serum immunoglobulins, and HIV. They also recorded treatment, response, and repeat-biopsy findings for each patient. They found that most of the 72 cases were classified as seronegative celiac disease, medication-related villous atrophy, and unclassified sprue. The majority of patients diagnosed with unclassified sprue reported symptomatic improvement with immunosuppressive therapy. Some patients diagnosed with unclassified sprue were found to have villous atrophy associated with the use of olmesartan. The team encourages further examination of the role of medications in the development of villous atrophy, along with the optimal dose and length of immunosuppression for patients with unclassified sprue. Source: Am J Gastroenterol. 2013 May;108(5):647-53. doi: 10.1038/ajg.2013.45.
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Celiac.com 10/20/2010 - U.S. doctors and patients looking for accurate early diagnosis of celiac disease now have a state of the art celiac disease assay with a high level of sensitivity and specificity. The US Food and Drug Administration (FDA) has given 510(k) clearance for the first two fully automated gliadin tests featuring deamidated peptides for celiac disease. Manufactured by Phadia US, the tests, EliA GliadinDP IgA and EliA GliadinDP IgG, are designed to be used in conjunct with other laboratory and clinical findings in the early diagnosis of celiac disease. According to Gabi Gross, autoimmune franchise leader for Phadia US, "EliA GliadinDP IgA and EliA GliadinDP IgG will offer physicians who suspect a possible case of celiac disease, antibody tests with the lowest number of false positive results." This means less "unnecessary endoscopies and biopsies," she adds. EliA GliadinDP IgA and EliA GliadinDP IgG will offer antibody tests with the lowest number of false positive results for doctors who suspect a patient has celiac disease. The assays are optional on Laboratory Systems Phadia 100Є and Phadia 250 instruments with features like quick turnaround, monthly calibration, onboard instrument dilution, and a discrete single-well, random-access, nonmicrotiter plate format. Phadia also manufactures other approved CLIA moderately complex assays in the EliA autoimmune product line, including anticardiolipin IgG/IgM, anti-B2-glycoprotein 1 IgG/IgM, cyclic citrullinated peptide, tissue transglutaminase IgA/ IgG, gliadin IgA/IgG, dsDNA, antinuclear antibody screen, and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP, and Jo-1. Source: Medscape
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