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Celiac.com 07/12/2024 - The Gluten-Free Certification Organization (GFCO) has long been considered a gold standard for gluten-free certification, offering rigorous testing and certification processes to ensure that products meet strict gluten-free criteria. However, a recent study conducted by Moms Across America has raised significant concerns about the reliability of GFCO's certification. The study found that 15% of randomly tested GFCO-certified products contained gluten levels above the organization's threshold of 10 parts per million (ppm), prompting a re-evaluation of GFCO’s procedures and standards. Understanding GFCO Certification The Gluten-Free Certification Organization (GFCO) is a program under the Gluten Intolerance Group (GIG) and is dedicated to certifying gluten-free products. The GFCO certification mark is a symbol of trust for consumers with celiac disease and gluten sensitivity, ensuring that products meet stringent gluten-free standards. According to the GFCO Manual Rev. 2024, the certification process involves several steps: Application: Companies must submit detailed information about their products and manufacturing processes. Audit and Testing: GFCO performs thorough audits and rigorous testing of products to detect gluten presence, using methods such as enzyme-linked immunosorbent assay (ELISA). Approval and Licensing: Products that pass the audit and testing phases receive GFCO certification and can display the certification mark. Ongoing Compliance: Certified companies must undergo annual audits and regular testing to maintain certification. GFCO sets a strict gluten threshold of less than 10 ppm, which is more rigorous than the 20 ppm threshold set by the FDA. Findings from Moms Across America Study The recent study by Moms Across America has challenged the perceived reliability of GFCO's certification. The study tested 46 products, 32 of which were GFCO-certified, and found that 5 of these certified products contained gluten levels exceeding 10 ppm. This translates to 15% of the tested GFCO-certified products failing to meet the advertised 10 ppm certified gluten-free standard. Even more concerning, 3 of the 5 products that were GFCO certified contained gluten above the FDA's gluten-free limit of 20 ppm—so nearly 10% of them cannot even be labeled as gluten-free! The study's findings have already spawned a class-action lawsuit against Trader Joe's for the gluten content found in their Everything Gluten-Free Bagels. Analysis by Celiac.com - Possible Issues with Step-Down Testing Procedure Celiac.com conducted an in-depth analysis of the Moms Across America study and scrutinized the GFCO Manual Rev. 2024. Our findings suggest that the compliance issues may stem from the "step-down" testing procedure allowed under GFCO guidelines. According to the manual, companies with a history of negative test results are permitted to reduce the frequency of their product testing. This "step-down" approach can lead to decreased vigilance over time, potentially allowing gluten contamination to go undetected: The specific testing schedule outlined in the manual is as follows: Initial Testing: Test 40 consecutive lots three times per lot. Step Down 1: If all tests are negative, reduce to testing once per lot for 40 consecutive lots. Step Down 2: If negative, test any one certified product on 40 consecutive production days. Step Down 3: If negative, test any one certified product during 40 consecutive production weeks. Step Down 4: If negative, test any one certified product during 40 consecutive production months. Final Step Down: If negative, test any one certified product during each production quarter. Additional testing schedules are provided for products initially tested less frequently: Once per day: Follow the same step-down process, reducing to weekly, then monthly, and finally quarterly if all results are negative. Once per week: Reduce to monthly testing after 40 consecutive weeks of negative results, then quarterly if all remain negative. Once per month: After 40 consecutive months of negative results, testing can be reduced to once per quarter. If any product tests positive for gluten at any stage, the company must return to the higher level of testing frequency immediately. No plant is permitted to test less frequently than once per calendar quarter, ensuring a minimum level of ongoing scrutiny. Allowing Self Testing Poses a Conflict of Interest On page 26 of: https://gfco.org/wp-content/uploads/2024/05/GFCO-Manual.pdf The companies themselves, as opposed to an independent laboratory, can perform all GFCO certification testing, as long as they use a "GFCO-approved method." This model seems to open the door for an obvious conflict of interest issue where a company could send in false results, or test a different batch than one which might test over 10ppm. Any company could have a financial motivation to avoid a product recall, which is a very expensive process, or to avoid destroying a batch of products rather than selling them. Given that companies can run all certification testing themselves, which can present potential conflicts of interest, the best solution would be for all testing to be done by an independent laboratory who would report the results directly to the GFCO, and those results should be publicly available on the GFCO website. Implications for the Gluten-Free Community The study's findings are particularly concerning for individuals with celiac disease, who rely on accurate gluten-free labeling to manage their health. Ingesting even small amounts of gluten can cause severe health issues for those with celiac disease, making reliable certification critical. The discovery that 15% of randomly selected GFCO-certified products contained gluten above the 10 ppm threshold undermines consumer confidence in GFCO's gluten-free certification. Call for Stricter Testing Protocols In light of these findings, there is a pressing need for GFCO to re-evaluate its testing protocols. The step-down approach, while offering companies less hassle and expense after passing a certain threshold, may not provide the consistent oversight necessary to ensure that all products remain gluten-free over time. Increased frequency of testing, even for companies with a history of compliance, could help mitigate the risk of gluten contamination and maintain the reputation of the GFCO gluten-free certification. Conclusion The recent study by Moms Across America highlights significant gaps in the current GFCO certification process. While the GFCO has set a high standard for gluten-free certification, the allowance for reduced testing frequency has revealed vulnerabilities that may need to be addressed. For individuals with celiac disease, the reliability of gluten-free certification is not just a matter of preference but a critical component of their health and well-being. Strengthening testing protocols and maintaining rigorous standards are essential steps toward restoring consumer trust and ensuring the safety of gluten-free products. Note: Celiac.com reached out to the GFCO for comment about our article, but did not receive a response. Join our forum discussion on this topic, and feel free to comment below. 08/08/2024 - Article updated to add "Allowing Self Testing Poses a Conflict of Interest" section.

Celiac.com 06/22/2024 - Celiac disease is an autoimmune disorder where gluten ingestion damages the small intestine. Traditionally, diagnosis involves blood tests for specific antibodies and a confirmatory biopsy, an invasive procedure with associated risks. Research is exploring less invasive methods, including the use of tissue transglutaminase immunoglobulin A (TTG-IgA) antibodies as a potential predictor. Study Overview A recent study presented at Digestive Disease Week 2024 investigated the accuracy of TTG-IgA antibodies in diagnosing celiac disease without biopsy. The study looked at patients located at six U.S. sites who had undergone esophagogastroduodenoscopy (EGD) and TTG-IgA testing. Exclusions were made for prior celiac diagnosis, IgA deficiency, or adherence to a gluten-free diet to maintain result accuracy. Key Findings - Patient Demographics and Biopsy Results Among 4,312 patients, 27.5% showed villous atrophy, indicating celiac disease. These patients were typically younger (average age 41) and predominantly non-Hispanic white (89.5%). They had significantly higher TTG-IgA levels, averaging five times the upper limit of normal (ULN). Diagnostic Accuracy of TTG-IgA The study revealed that over a quarter of patients had elevated TTG-IgA levels. For any level above the ULN, sensitivity was 81.8%, and specificity was 95.7%. The positive predictive value (87.7%) and negative predictive value (93.3%) supported the test's overall accuracy, which was 91%. The area that was under the receiver operating characteristic curve (AUC) was 0.92, indicating high accuracy. High TTG-IgA Levels In patients with TTG-IgA levels of more than 10 times the ULN, only two out of 132 did not have villous atrophy, resulting in a false-positive rate of 0.1%. This suggests that very high TTG-IgA levels are a strong indicator of celiac disease and could potentially reduce the need for biopsy. Implications for Noninvasive Diagnosis Lead investigator Dr. Claire Jansson-Knodell noted the potential for TTG-IgA to serve as a noninvasive diagnostic tool, particularly for patients with very high antibody levels. However, caution is advised for cases with mildly elevated TTG-IgA, where diagnostic accuracy may not be sufficient to eliminate the need for a biopsy. Future Research The research team plans to conduct a prospective study to gather more data, aiming to confirm the practicality and reliability of using TTG-IgA as a noninvasive diagnostic tool in clinical practice. Conclusion This study suggests that TTG-IgA antibodies hold significant potential as a noninvasive diagnostic indicator for celiac disease, particularly in patients with very high antibody levels. While promising, further research is needed to validate these findings and ensure the accuracy and safety of using TTG-IgA as a standalone diagnostic tool. This could lead to a future where a simple blood test replaces the need for invasive biopsy in diagnosing celiac disease. Read more: gastroendonews.com

Celiac.com 05/27/2024 - Celiac disease diagnosis typically involves a two-step process, including antibody detection and endoscopy with duodenal biopsy. However, recent evidence suggests that elevated IgA anti-tissue transglutaminase (tTG) levels may accurately predict celiac disease, potentially eliminating the need for biopsy. This study aimed to assess the accuracy of the no-biopsy approach in diagnosing celiac disease in adults. Methods - A Systematic Review and Meta-analysis A systematic review and meta-analysis were conducted, including studies reporting on IgA-tTG levels ≥10 times the upper limit of normal (ULN) against duodenal biopsies in adults with suspected celiac disease. Sensitivity, specificity, and likelihood ratios were calculated, with positive predictive values determined across different disease prevalence rates. Results - IgA-tTG levels ≥10×ULN had 100% Specificity and a Positive Predictive Value of 98% The meta-analysis of 18 studies with over 12,000 participants indicated that IgA-tTG levels ≥10×ULN had 100% specificity and a positive predictive value of 98% for celiac disease in adult patients referred to secondary care. The predictive value varied based on disease prevalence, with a 99% positive predictive value at a 40% disease prevalence rate. Conclusion & Discussion The findings support the no-biopsy approach for selected adult patients with high IgA-tTG levels and moderate to high celiac disease pretest probability, potentially avoiding invasive endoscopy and biopsy. Collaboration between primary and secondary care is crucial for successful implementation, considering patient preferences and risk factors. Further research is needed to evaluate this approach in primary care and low-pretest probability cases, as well as its cost-effectiveness and regulatory implications. The study provides robust evidence for the no-biopsy approach in diagnosing celiac disease in adults, aligning with pediatric guidelines. However, concerns regarding false-positive diagnoses and missed concurrent pathology warrant careful patient assessment and diagnostic pathway standardization. Collaboration and shared decision-making are key to successful implementation, emphasizing the need for clear clinical guidelines and educational initiatives. Future Directions Future research should focus on evaluating the no-biopsy approach in primary care and low-pretest probability cases, assessing lower IgA-tTG thresholds, and considering the role of confirmatory testing. Additionally, studies on patient preferences, cost-effectiveness, and regulatory aspects are necessary to determine the approach's feasibility and impact in clinical practice. Read more at: gastrojournal.org

Celiac.com 08/21/2023 - Researchers from the University of Kentucky's Martin-Gatton College of Agriculture, Food, and Environment have developed a new and highly effective method for detecting and measuring wheat flour contamination in gluten-free food. Their improved testing methods could significantly improve gluten-free food safety. Gluten-free diets are crucial for individuals with coeliac disease and other conditions that require avoiding gluten. In the UK, approximately 10% of consumers opt for gluten-free products. However, ensuring the absence of gluten in these foods is challenging due to possible cross-contamination in the supply chain. Fourier-transform Infrared Spectroscopy and Machine Learning to Detect Wheat The research team focused on detecting wheat (gluten) flour contamination in gluten-free cornbread using Fourier-transform infrared (FTIR) spectroscopy and machine learning. FTIR employs infrared light absorption to identify a sample's organic and inorganic compounds. Akinbode Adedeji, the principal investigator and an associate professor in biosystems and agricultural engineering, highlighted the prevalence of allergen contamination in the food industry and the need for a rapid method to identify gluten contamination, especially given the sensitivity of individuals with gluten intolerance. To develop the method, the team prepared 13 different cornbread samples with varying levels of wheat flour contamination using corn flour and wheat flour. They analyzed the samples using FTIR with a 'special diamond accessory.' Before using machine learning, they pre-processed the spectra to reduce noise in the raw data and isolate key spectral features, simplifying the machine learning process. A Game-changer for Gluten-Free Food Safety This new testing method could be a game-changer for gluten-free food safety, as it offers manufacturers a reliable and efficient way to ensure their products are truly gluten-free, and safe for individuals with gluten-related conditions. By implementing this technique, the food industry can improve the accuracy of gluten-free labeling and increase consumer confidence in gluten-free products. Read more at foodmanufacturer.co.uk

Celiac.com 12/10/2022 - Increased awareness and celiac disease-specific diagnostic tests have aided the diagnosis of celiac disease. For instance, blood antibody testing has become a useful tool for screening suspected cases of celiac disease. These blood tests can be very sensitive in the detection of patients with severe intestinal damage, but invariably are negative in patients with mild lesions(1). Furthermore, some pathologists are not experienced in recognizing and detecting cases in which mild intestinal damage or even partial villous atrophy is present in biopsy samples. Yet, for these tests to be accurate a patient must be on a gluten-containing diet and doctors often put patients on an oral gluten challenge only after the patient has been on a gluten-free diet and/or their blood antibody tests prove negative. The oral gluten challenge requires a patient to ingest gluten at the direction of a specialist such as a gastroenterologist for testing purposes such as preparation for an endoscopic exam with biopsies of the small intestine, still considered the gold standard of diagnosis. The demands of the oral gluten challenge are time-consuming, can exacerbate or provoke symptoms, and intentionally put celiac patients at risk for further intestinal damage. As a patient, I was gluten-challenged because I had already instituted a gluten-free diet (despite negative blood antibody tests), three weeks before my appointment with the gastroenterologist. I suffered intense and severe symptoms that were provoked by the gluten challenges—not to mention the psychological impact posed by the challenges. At the direction of my gastroenterologist, I was instructed to "make complete damage" in a span of several days upon the first of three, short gluten challenges. At one point, I was ingesting gluten up to seven times in one day. After the close of the third gluten challenge, I felt chronically cold; it was difficult to walk without extreme fatigue and weakness; and I found it difficult to eat or drink due to intense, unrelenting stomach spasms. I had already lost ten percent of my weight before the gluten challenges but lost an additional seven percent after the gluten challenges. Furthermore, I began experiencing heart symptoms and suffered constant and severe joint pain in my extremities. The gluten challenges devastated my already compromised health and made my recovery more difficult and fraught with further complications. It has become clear that there is a need for methods of testing which do not expose patients to the health risks of an oral gluten challenge. Also, tests that offer more sensitive diagnostic value are needed for prompt and early diagnosis. Several research studies have evaluated the diagnostic potential of various methods without the requirement of an oral gluten challenge. Some of these studies examine the possibility of challenging intestinal biopsies with gluten outside the body in culture media (in vitro). Other studies have tested the immune response elicited by sites outside the small intestine. In vitro gluten challenge Today, anti-endomysial antibodies (EmAs) and anti-tissue transglutaminase antibodies (tTGs) are being used in the detection of celiac disease because of their sensitivity (detection of true CD-positive patients) and specificity (omission of non-celiac patients)(2). However, the blood antibody screening tests have not proven sensitive enough in the presence of mild intestinal damage or whereby only an increased intestinal lymphocyte (a type of white blood cell) count is present as a sign of the immune activation(1,3). Therefore, the production of EmA in cultured intestinal biopsies challenged with gliadin has been evaluated for its usefulness in celiac disease diagnosis. Carroccio et al found that EmA positivity of cultured biopsies challenged with gliadin for 48 hours correlated with the degree of intestinal damage, the shorter the treatment with a gluten-free diet (i.e., newly diagnosed celiac patients), and higher counts of inflammatory cells (i.e., white blood cells including lymphocytes) in the intestinal biopsies(2). A higher proportion of celiac patients with more severe intestinal lesions (95%) were EmA positive in their gliadin-challenged cultured biopsies as compared to celiac patients with mild intestinal damage (75%) who were EmA positive. However, this test still had higher sensitivity to detect 58% more celiac patients with mild intestinal damage than the blood EmA tests which were positive in only 17% of them. Furthermore, in newly diagnosed celiac patients, 90% of patients were EmA positive in their cultured biopsies before the addition of gliadin and 96% with the addition of gliadin. Finally, those patients who were EmA positive with the biopsy culture challenge with gliadin had significant higher numbers of inflammatory cells than those who were negative. Sixty-two percent of celiac patients on a gluten-free diet (GFD-treated) for 12 months, were EmA positive in biopsies challenged in culture with gliadin for 24 hours(4). EmA was not observed in any of their pre-challenge biopsies. However, EmA was detected in all of the cultured intestinal biopsy samples, challenged with gliadin after 72 hours. In addition, none of the control (non-celiac) patients had EmA detectable in their biopsies challenged in culture with or without gliadin. Local Challenge of Nasal Tissue and Oral Lining Other exciting prospects in the diagnosis of celiac disease are on the horizon which offer easy access to testing. For instance, other sites outside the intestine such as the nasal tissue and the oral lining are being studied for whether they can elicit a gliadin-specific immune response. In a study of GFD-treated celiac patients, gluten provoked a significant but only mild gliadin-specific inflammatory response in the nasal tissue scrapings (not biopsies) of the celiac patients via activation of lymphocyte cells but not in control patients(5). Another study involved the injection of gliadin into the oral lining of ten GFD-treated celiac patients who were negative for EmA(6). After a 24-hour gliadin challenge, oral biopsies were taken and the number of lymphocytes was significantly increased in celiac patients but not in the controls. Further evaluation of these methods, including studies of untreated patients, is needed to confirm their usefulness in the diagnosis of celiac disease. Rectal Gluten Challenge The rectum is an easily accessible site for which a gluten challenge can be performed and rectal biopsies taken7. The test does not require any patient preparation or the more invasive procedure of an endoscopic exam with biopsies. Also, no pre-challenge biopsies are required for comparison. The diagnostic power of the rectal gluten challenge is demonstrated by its ability to recognize gluten sensitive patients whose blood antibody tests are negative at presentation or whose biopsies are inconclusive(7). The four-hour rectal gluten challenge provided both 100 percent specificity and sensitivity in the diagnosis of gluten-sensitive patients in comparison with blood EmA which had only a 70% sensitivity and 98% specificity. In a group of 45 untreated patients, the rectal gluten challenge showed a significant increase in the numbers of lymphocytes responding to gluten whereas the non-celiac group of patients demonstrated a negative response in their lymphocyte populations. Furthermore, celiac patients on a GFD for two or more years still had more rectal lymphocytes than non-celiacs(8). Post rectal gluten challenge results of biopsy samples disclosed a significantly increased inflammatory infiltration of lymphocyte cells in celiacs but not in control patients. Inherently, the traditional oral gluten challenge is designed to cause intestinal damage to a celiac patient and may exacerbate or provoke symptoms, which may not be acceptable to the patient. The true cost of a diagnosis of celiac disease is the overt and acute as well as silent and chronic damage to the celiac patient caused by the undertaking of an oral gluten challenge. However, the future use of alternative diagnostic tests in practice offers the patient choices outside the risks and complications of oral gluten challenges. Since rectal gluten challenges, as well as the oral or nasal gluten challenges, must be taken internally, more studies must be done to evaluate the safety of using these potential methods of diagnosis. Some of these studies sought to find a more sensitive way to detect early events in the staging of celiac disease. Others also sought to find if the immune system could identify gliadin outside the gastrointestinal tract to make testing more accessible and easier on the patient. Both the sensitivity and specificity of methods such as EmA detection in cultured biopsies challenged with gliadin may one day change the way celiac disease is currently diagnosed, in the presence of more severe intestinal damage or villous atrophy. Instead, these alternative methods to oral gluten challenge have the potential to facilitate early diagnosis of celiac patients with inconclusive biopsies, those with only mild intestinal damage and negative blood antibody tests as well as high-risk patients such as relatives of celiac patients, and patients with associated autoimmune diseases. References: Tursi A, et al. 2003. The symptomatic and histologic response to a gluten-free diet in patients with borderline enteropathy. J Clin Gastroenterol 36: 13-17. Carroccio A, et al, 2002. Production of anti-endomysial antibodies in cultured duodenal mucosa: Usefulness in coeliac disease diagnosis, Scand J Gastroenterol 37: 32-38. Tursi A, et al. 2003. Prevalence of antitissue tranglutaminase antibodies in different degrees of intestinal damage in celiac disease. J Clin Gastroenterol 36: 219-21. Picarelli A, et al, 2001. Forty-eight hours of biopsy culture improve the sensitivity of the in vitro gliadin challenge in the diagnosis of celiac disease, Clin Chem 47: 1841- 1843. Torre P, et al, 2002. Immune response of the coeliac nasal mucosa to locally-instilled gliadin, Clin Exp Immunol 127: 513-518. Lahteenoja H, et al, 2000b. Local challenge on oral mucosa with an alpha-gliadin related synthetic peptide in patients with celiac disease, Amer Jour Gastroenterol 95: 2880-87. Ensari A, et al, 2001. Diagnosing coeliac disease by rectal gluten challenge: a prospective study based on immunopathology, computerized image analysis and logistic regression analysis, Clin Sci 101: 199-207. Troncone R, et al, 1996. In siblings of celiac children, rectal gluten challenge reveals gluten sensitization

Celiac.com 04/16/2019 (originally published 04/24/2008) - Genetic tests for celiac disease and gluten sensitivity are readily available. Testing can be performed on either blood and mouth swab samples. Tests can be done at home and mailed to the lab for analysis. A good testing laboratory will provide an accurate prediction of celiac disease risk, and will also provide information about the statistical risk to your children, your likelihood of developing more severe celiac disease, whether one or both of your parents had the risk gene, and for some laboratories, you may determine your risk of gluten sensitivity without celiac disease. DQ2 & DQ8 Not the Whole Story About 95% of celiacs carry HLA-DQ2; while about 25% carry HLA-DQ8. If any part of the high risk gene patterns DQ2 and DQ8 is missing, then the likelihood of that person getting celiac disease is 99.9% AGAINST. Negative Genetic Test Only Part of the Story However, "negative celiac genetic testing” is not sufficient for entirely ruling out celiac disease. To definitively declare negative celiac genetic tests requires the laboratory to test for the presence or absence of the entire HLA DQ genetic pattern, including both alpha and beta subunits. The DQ genetic patterns DQ2 and DQ8 have two subunits, but many laboratories only test for the beta subunit. Few labs test for both. This DQ typing is complicated and difficult to understand even by physicians and scientists. I have written an updated detailed review that appears in the Spring 2008 issue of Scott-Free newsletter published by celiac.com. No DQ2 & DQ8 Can Still Mean Gluten Problems Data collected by Dr. Ken Fine of Enterolab supports the fact that the absence of DQ2 and DQ8 does not exclude the risk of being gluten intolerance or sensitive, though it is now looks likely that one or both of those genetic white blood cell patterns are required for celiac disease or celiac sprue to develop. However, there is a new study that reports that being negative for DQ2 and DQ8 does not completely exclude the possibility of celiac disease, especially in men. Previous studies have documented blood test negative celiac sprue, which is also more common in elderly men with long-standing severe disease. Since DQ2 or DQ8 is almost universally present where tissue transglutaminase and anti-endomysial antibodies are present it is not surprising that individuals without DQ2 or DQ8 with negative blood tests are being reported that meet criteria for celiac disease. These new studies are also providing further information that the genetics of celiac is gender specific. If you are a man, your risk of celiac disease may be higher than a woman if you don't have the classic genetic patterns. Again, in this situation your blood tests may be negative. If you are a woman, the risk for Celiac disease is generally higher than a man, especially if you have received the at risk gene from your father instead of your mother. Celiac disease is arguably the most common autoimmune disease. It is very common. It is easily treated. It affects 1/100 people worldwide. However, most people with celiac disease (~90%) are unaware, undiagnosed or misdiagnosed. Most adults finally diagnosed with celiac disease have suffered at least 10-11 years, and have seen 3 or more doctors. Genetic testing can be extremely helpful in determining your risk for celiac disease, potential severity, and risk for family members. Don't be one of those whose diagnosis is missed or needlessly delayed for over a decade. Get tested! Learn about the genetic tests for celiac disease and if necessary educate your doctor about this testing. Important Facts About Celiac Disease: Genetic Testing Can Determine Celiac Risk Celiac genetic tests can be done on blood or a mouth swab sample but your doctor may be unaware of the tests, not know how to order them, or know how to interpret the results. Diet Will Not Change Genetic Test Results Genetic testing is not affected by diet. You can be eating gluten or on a gluten-free diet. Unlike blood tests for celiac disease antibodies, which require a patient to be eating gluten, genetic tests can be done whether or not the person being tested is eating wheat or gluten. Diagnostic Codes Can Help Secure Insurance Approval Many insurance companies pay for celiac genetic testing. Most that pay require pre-authorization. The following diagnostic codes are helpful when requesting insurance coverage: 579.0 (celiac disease); V18.59 (family history of GI disease); and/or V84.89 (genetic susceptibility to disease). Some Genetic Labs Perform Limited Tests Many laboratories do not perform the all of the necessary components of the test to completely exclude the possible genetic risk of celiac disease and most don't test for or report the other gluten sensitive DQ patterns. Before you accept that have a negative test you need to know if your test included both the alpha and beta subunits of HLA DQ or did they just perform the beta typing. Negative Results Can Still Mean Celiac in Rare Cases In rare cases, some people, especially men, may have a negative genetic test and still have celiac disease. As with blood tests, men more commonly have negative genetic tests, especially older men with long-standing severe disease. DQ Type Can Influence Celiac Risk and Severity Both the DQ type, and number of copies you have, matter when determining not only your risk, but also the possible severity of celiac disease. Two copies of DQ2 carries more risk than one copy of DQ8 or only partial DQ2. Even a single copy of DQ2 alpha subunit ("half DQ2 positive") carries risk for celiac disease, but most of the commonly used laboratories for Celiac genetics do not test for or report the presence of this component of the celiac genes. Negative DQ2 and DQ8 Can Still Mean Gluten Intolerance The absence of at risk genes DQ2 and/or DQ8 does not exclude the possibility of being gluten intolerant or sensitive. You may respond to a gluten free diet, even if you don't have DQ2 or DQ8, or true autoimmune celiac disease. No Prescription Needed for Genetic Celiac Testing You can get genetic testing without a doctor's order and the tests can be done without having blood drawn or insurance authorization if you are willing to pay between $99-300 (www.enterolab.com). Genetic Testing Labs for Celiac Disease Laboratories in the U.S. that are known to offer complete alpha and beta subunit genetic testing include Kimball Genetics, Prometheus, and LabCorp. Bonfils, Quest and Enterolab only test for the beta subunit portions and therefore their test can miss part of a minor alpha subunit that carries a risk of celiac disease. A negative DQ2 and DQ8 report from these labs may not necessarily be truly negative for the risk of celiac disease. Celiac Genetic Testing References and Resources: HLA-DQ and Susceptibility to Celiac Disease: Evidence for Gender Differences and Parent-of-Origin Effects. Megiorni F et al. Am Journal Gastroenterol. 2008;103:997-1003. Celiac Genetics. Dr. Scot Lewey. Scott-Free, Spring 2008.

Celiac.com 08/21/2020 - So who, exactly, should be screened for celiac disease? The guidelines and parameters for who and when to test for celiac disease change as new data becomes available. Based on recent study data, and recommendations by the three major celiac disease organizations, many doctors advise celiac screening for patients with any of the following twenty-two conditions or diseases: Anemia Unexplained iron, vitamin B12 or folate deficiency. A 2014 study showed that celiac disease is common in people with unexplained anemia. The study team recommends celiac screening for anyone with unexplained iron-deficient anemia, while the The U.K. National Institute for Health and Care Excellence recommend celiac screening for anyone with unexplained vitamin B-12 or folate deficiency. Aphthous stomatitis People with severe or persistent mouth ulcers (canker sores) should get screened for celiac disease. A 2020 study confirms that doctors should consider celiac disease in patients with severe or recurrent aphthous stomatitis. Autism People with autism have celiac disease at rates almost 20 times higher than in those without autism, reported lead investigator Daniel Karb, MD, a second-year resident at University Hospitals Case Medical Center in Cleveland. As such, many doctors now recommend celiac screening for people with autism. Autoimmune Thyroid Disease The The U.K. National Institute for Health and Care Excellence recommends celiac screening for anyone with thyroid disease. Dental Enamel Defects Certain types of dental enamel defects can be strong indicators of celiac disease. A 2018 study shows that non-specific tooth wear and enamel defects can be strong indications of celiac disease. Dermatitis Herpetiformis (DH) People with dermatitis herpetiformis, aka DH, or Duhring’s disease, suffer from a herpes-like rash. About 10% to 15% of people with celiac disease have DH. Anyone with DH should be checked for celiac disease. Most people with DH see major improvements on a gluten-free diet. Failure to Thrive and Persistent Diarrhea in Children The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and The American College of Gastroenterology recommends celiac screening for children with failure to thrive, especially with persistent diarrhea. Unexplained Fatigue Unexplained fatigue. People with persistent unexplained fatigue should consider screening for celiac disease, according to the U.K. National Institute for Health and Care Excellence. GERD Some studies show no link between Gastroesophageal Reflux Disease (GERD) and celiac disease. A 2015 study showed that celiac disease not a big factor in gastro-esophageal reflux disease. But a 2020 study showed that non-celiac gluten sensitivity is common in patients with refractory functional dyspepsia. Many doctors recommend celiac disease screening for patients with GERD. High Transaminase Levels High transaminase levels can be an indication of liver damage, heart damage, and are common in people with celiac disease. Down syndrome A 2020 study shows that people with Down syndrome have celiac disease at up to twenty times the rate of the general population. Celiac disease screening is important for anyone with Down syndrome. IgA Deficiency The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends testing for celiac disease in asymptomatic children who have conditions associated with celiac disease, including selective IgA deficiency. Irritable Bowel Syndrome in Adults Adults with irritable bowel syndrome should be screened for celiac disease, according to the The U.K. National Institute for Health and Care Excellence. Persistent Unexplained Elevated Liver Enzymes The U.K. National Institute for Health and Care Excellence recommends celiac screening for people with persistently elevated liver enzymes with unknown cause. Recurrent Miscarriages The U.K. National Institute for Health and Care Excellence recommends celiac screening for women who experience recurrent miscarriages. Immediate Relatives of Anyone with Celiac Disease First-degree relatives (mother, father, brother, sister, son, daughter) of anyone with celiac disease should get a celiac screen, according to Mayo Clinic. Short Stature A 2020 study shows that biopsy confirmed celiac disease affects about 1 in 14 patients with all‐cause short stature, and 1 in 9 patients with idiopathic short stature. Based on these results, doctors are recommending screening all patients with short stature should be screened for celiac disease. Thyroiditis Thyroiditis is an auto-immune condition associated with celiac disease. The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) recommends celiac disease screening in children who have thyroiditis. Turner syndrome Turner syndrome is associated with celiac disease. The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) recommends celiac disease screening in children who have Turner syndrome. celiac.comhttps://www.celiac.com/celiac-disease/who-should-get-screened-for-celiac-disease-r5201/ Type 1 diabetes More than 20% of people with Type 1 diabetes have celiac disease. The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) recommends celiac disease screening in children who have Type 1 diabetes. Unexplained Infertility Women with infertility face higher rates of celiac disease. Many doctors do not screen for celiac disease in these women. However, for women experiencing unexplained infertility, especially repeatedly, a celiac disease screen is probably a good idea. Unexplained Neuropathy Patients with unexplained neuropathy, or small fiber neuropathy should be screened for celiac disease and gluten-sensitivity, according to researchers. Unexplained Weight Loss According to the U.K. National Institute for Health and Care Excellence, people who suffer from unexplained weight loss should be screened for celiac disease. Consider Celiac Screening for These Common Physical Complaints People with any of the ten most common complaints of celiac patients, or any of the below conditions that are associated with celiac disease, along with any obvious signs of celiac disease, including persistent diarrhea or stomach upset, should consider celiac screening. These include: Anemia Alternating bowel habit Bloating Constipation Cryptogenic hypertransaminasemia Diarrhea Gastroesophageal reflux disease Osteopenia/Osteoporosis Recurrent miscarriages Unexplained Infertility Other Conditions Associated with Celiac Disease The following conditions are not included in the official celiac screening recommendations by the above organizations. However, anyone with any of the following conditions, along with any obvious signs of celiac disease, including persistent diarrhea or stomach upset, should consider celiac screening. These include: Addisons Disease Alopecia Anxiety and Depression Ataxia Attention Deficit Disorder/ADHD Autism Autoimmune Hepatitis / Chronic Active Hepatitis Bird Fanciers Lung Brain White-Matter Lesions Cerebellar Atrophy Chronic Fatigue Syndrome (myalgic encephalomyelitis or ME, PVS, post viral fatigue syndrome or PVFS) Crohns Disease Congenital Heart Disease Cystic Fibrosis Dental-Enamel Hypoplasia Dyspepsia Epilepsy (with or without cerebral calcification) Farmers Lung Fibromyalgia and Celiac Disease Fibrosing Alveolitis Follicular Keratosis Gall Bladder Disease Gastroparesis Head Aches (Migraine) IBD - Irritable Bowel Disease Impotency Infertility Inflammatory Bowel Disease Lung Cavities Multiple Sclerosis and Celiac Disease Myasthenia Gravis Pancreatic Disorders / Exocrine Pancreatic Insufficiency Peripheral Neuropathy Polymyositis Polyneuropathy Primary Biliary Cirrhosis Pulmonary Hemosiderosis Recurrent Pericarditis Sarcoidosis Schizophrenia / Mental Problems and Celiac Disease Scleroderma Short Stature, Delayed Puberty Small-Intestinal Adenocarcinomas Spontaneous Abortion and Fetal Growth Retardation Systemic Lupus Erythematosus Thrombocytosis (Hyposplenism) Thrombocytopenic Purpura (ITP) Thyrotoxicosis Vasculitis Vitamin K Deficiency Celiac Disease Screening Recommendations by Organization The American College of Gastroenterology The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) The U.K. National Institute for Health and Care Excellence

Celiac.com 05/18/2022 - Idiopathic pulmonary hemosiderosis causes diffuse alveolar hemorrhage, but the mechanics of the cause remains unknown. Alveolar hemorrhage is a "life-threatening disorder characterized clinically by the presence of hemoptysis, falling hematocrit, diffuse pulmonary infiltrates and hypoxemic respiratory failure. Diffuse alveolar hemorrhage should be considered a medical emergency due to the morbidity and mortality associated with failure to treat the disorder promptly." The occurrence of idiopathic pulmonary hemosiderosis and celiac disease together has been noted in both children and adults, and is also known as Lane-Hamilton syndrome. A team of researchers recently set out to compare demographics, clinical and radiologic findings, treatment, and outcomes between adult patients with idiopathic pulmonary hemosiderosis and Lane-Hamilton syndrome. The research team included Biplab K. Saha, Praveen Datar, Alexis Aiman, Alyssa Bonnier, Santu Saha, and Nils T. Milman. They are variously affiliated with the Department of Clinical Biochemistry, University College Zealand in Næstved, Denmark; the department of Internal Medicine, New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro, USA; the Pulmonary and Critical Care Medicine, Ozarks Medical Center · West Plains, USA; the center for Critical Care, Goldfarb School of Nursing at Barnes Jewish College · Saint Louis, USA; and the Internal Medicine, Saha Clinic in Narail, Bangladesh. For their systematic review of the literature, the team used proper search parameters to identify relevant articles in multiple databases. Their final review included a total of 60 studies reporting 65 patients. Forty-nine of these patients had idiopathic pulmonary hemosiderosis, while 16 had Lane-Hamilton syndrome. Thirteen of twenty-two patients screened, nearly sixty percent, were positive for anti-celiac antibodies. Patients with Lane-Hamilton syndrome showed earlier symptom onset and diagnosis of idiopathic pulmonary hemosiderosis, though both groups showed an average delay in diagnosis of about one year. Lane-Hamilton syndrome patients were most likely to show the classic symptom triad, although only one in five patients in the Lane-Hamilton syndrome group showed any significant gastrointestinal symptoms at the time of idiopathic pulmonary hemosiderosis diagnosis. A gluten-free diet alone was effective in the majority of patients. Fewer patients in the Lane-Hamilton syndrome cohort received systemic corticosteroid than the idiopathic pulmonary hemosiderosis cohort. The recurrence and mortality in patients with Lane-Hamilton syndrome appear to be less than in the idiopathic pulmonary hemosiderosis cohort. The results show that one in four adult patients with idiopathic pulmonary hemosiderosis has celiac disease. Patients with Lane-Hamilton syndrome may show milder effects than patients without celiac disease. Based on these results, the researchers are recommending that all idiopathic pulmonary hemosiderosis patients receive serologic screening for celiac disease. Read more at Cureus.com 14(3): e23482

Celiac.com 12/15/2021 - The journey from symptoms to questions, to the search for a proper celiac disease diagnosis can be long, confusing, and frustrating. For many people with celiac disease, the pre-diagnosis phase is the most challenging part of the journey. A glance at our popular online forum shows that questions about pre-diagnosis, testing and symptoms of celiac disease abound among celiac sufferers. To help make the journey a bit easier, we've put together this list of helpful things to know about per-diagnosis and testing for celiac disease. Celiac Disease Pre-Diagnosis & Testing Celiac Symptoms We'll start first with symptoms, because, for most patients, celiac symptoms are often what get the ball rolling toward testing and diagnosis. Classic celiac-associated gastrointestinal symptoms include malnutrition, diarrhea, abdominal pain, and bloating, weight-loss, or low body weight, among others. Interestingly, most people with celiac disease show no symptoms, but are diagnosed on the basis of referral for elevated risk factors. For people who do show symptoms, it is increasingly common to find atypical symptoms, such as being overweight, especially in children. In fact, most children with celiac disease now show atypical symptoms. An absence of symptoms, or the presence of atypical symptoms can make diagnosing celiac disease even more difficult, as patients often need a referral from a physician, who may have trouble justifying one if she can't point to clear symptoms. To make matters worse, celiac disease is often confused with numerous other diseases, which can cause delayed diagnosis, or even misdiagnosis. Celiac Disease Pre-Diagnosis When people talk about "pre-diagnosis" of celiac disease, they are usually talking about the testing phase. Usually, a person will have symptoms of one sort or another that will lead them to a physician, who will then request testing for celiac disease antibodies. In some cases, confirmation by biopsy is still the go-to procedure for officially confirming celiac disease, however, in Europe they are now diagnosing celiac disease via a blood test only when it detects a 10-fold increase in IgA antitissue transglutaminase (tTG) antibody levels above the reference range, in combination with EMA positivity, without the need for a duodenal biopsy. So in many cases, celiac disease can now be diagnosed by blood test alone, without the need for a follow-up biopsy, especially in children, first-degree family relatives, and even in many adults. Celiac Disease Blood Antibody Testing Traditionally, doctors will order a test to measure blood levels of anti-transglutaminase antibodies, or tTG2, which are higher in people with celiac disease. tTG2 proteins are among the proteins that trigger the immune reaction the causes inflammation when celiac eat wheat, rye, or barley. Celiacs have hundreds times more tTG proteins than non-celiacs. 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 low, 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 deficient then these two tests should be done: Tissue transglutaminase (tTG) antibody, IgG. Gliadin (deamidated) antibody, IgG. In fact, trials show the tTG blood test to be 95 percent sensitive (meaning it detects celiac disease 95 times out of 100), and 95 percent specific (meaning it gives a false positive result just 5 times out of 100). A Possible Future for Celiac Blood Tests One Blood Test Can Now Diagnose Celiac Disease without Biopsy New Screening Method Offers Faster and Easier Detection of Celiac Antibodies FDA Approves New Test for Celiac Disease A New York startup company, Aesku NY, has received FDA approval for tests to detect celiac disease. Patients who screen positive would require further testing for a specific diagnosis. However, the tests are designed to be cost effective, and efficient, potentially increasing the availability of a reliable screening method for diseases that are best caught and treated early. Blood Test Results Normally the results you get will be either negative, weak positive, or positive. Any positive blood test, even if others are negative, could indicate celiac disease. Read more about the Interpretation of Celiac Disease Blood Test Results Confirmation In some cases, biopsy is still the go-to procedure for officially confirming celiac disease. This is the case even in Europe when tTG levels are below 10x the reference range for celiac disease. There is some research to indicate that children, on average, may have less villi damage than adults, which is why blood test results are so important. Genetic Testing Genetic tests for celiac disease and gluten sensitivity are readily available. Testing can be performed on either blood or mouth swab samples. Tests can be done at home and mailed to the lab for analysis. A good testing laboratory will provide an accurate prediction of celiac disease risk, and will also provide information about the statistical risk to your children, your likelihood of developing more severe celiac disease, whether one or both of your parents had the risk gene, and for some laboratories, you may determine your risk of gluten sensitivity without celiac disease. Get the Facts About Celiac Disease Genetic Testing Genetic Test Results No DQ2 & DQ8 Can Still Mean Non-Celiac Gluten Sensitivity (NCGS) Data collected by Dr. Ken Fine of Enterolab supports the fact that the absence of DQ2 and DQ8 does not exclude the risk of gluten intolerance or gluten sensitivity, though it now looks likely that one or both of those genetic white blood cell patterns are required for celiac disease to develop. DQ Type Can Influence Celiac Risk and Severity Both the DQ type, and number of copies you have, help to determine the risk, and also the potential severity of celiac disease. Two copies of DQ2 carries more risk than one copy of DQ8 or only partial DQ2. Even a single copy of DQ2 alpha subunit ("half DQ2 positive") carries risk for celiac disease, but most of the commonly used laboratories for Celiac genetics do not test for or report the presence of this component of the celiac genes. The odds of developing celiac disease based on HLA-DQA/DQB genotypes is as follows: DQ2+DQ8 1:7 (14.3%) DQ2+DQ2 OR DQ2 Homozygous DQB1*02 1:10 (10%) DQ8+DQ8 1:12 (8.42%) DQ8+DQ8*02 1:24 (4.2%) Homozygous DQB1*02 1:26 (3.8%) DQ2 only 1:35 (2.9%) DQ8 only 1:89 (1.1%) General Population - Genotypes unknown 1:100 (1%) ½ DQ2*DQB1*02 1:210 (0.5%) ½ DQ2*DQA1*05 1:842 (0.05%) No HLA-DQA/DQB susceptible alleles 1:2518 (0.04%) Testing for celiac disease should be done using FDA-approved HLA test kits. HLA-DQA/DQB genotyping typically provides detection of DQ2 (DQA1*0501, DQA1*0505, and DQB1*0201/*0202) and DQ8 (DQB1*0302) For example: HLA-DQ2(DQA1*05/DQB1*02) Positive or Negative HLA-DQ8(DQA1*03/DQB1*0302) Positive or Negative Conclusion For anyone in the pre-diagnosis phase of suspected celiac disease, the keys to effective screening and diagnosis lie in testing and diagnosis, with or without biopsy. If you have questions about specific issues, be sure to check into our celiac disease forum.

Celiac.com 07/12/2021 - When doctors test symptomatic children for celiac disease, they currently order biopsy confirmation only for children whose anti-transglutaminase IgA (TGA-IgA) titers exceed the upper limit of normal (ULN), and below 10 times the upper limit of normal. Any results below the ULN do not normally get referred for a biopsy. Now, this works pretty well in the sense that a high percentage of biopsies for such patients come up positive. However, the management of children with lower TGA-IgA values presents a clinical challenge. What about children who test just under the ULN cut off? Especially those with symptoms, however mild. Do persistently low positive TGA-IgA titers have any diagnostic value for predicting celiac disease in children? A team of researchers recently looked into this question. The research team included Chiara Marja Trovato; Monica Montuori; Annalisa Morelli; Danilo Alunni Fegatelli; Annarita Vestri; Carla Giordano; Salvatore Cucchiara; Giocomo Caio; and Salvatore Oliva. They are variously affiliated with the Pediatric Gastroenterology and Liver Unit, Maternal and Child Health Department; the Department of Statistical Science; and the Department of Radiological, Oncological and Pathological Sciences at Sapienza University of Rome; along with the Department of Medical Sciences at the University of Ferrara in Ferrara, Italy. The team retrospectively analyzed children with symptoms or signs of celiac disease, not eligible for a no-biopsy approach. Their study included children with at least two TGA-IgA measurements, endomysial antibody (EMA) assessment and esophagogastroduodenoscopy with biopsies. TGA-IgA values were provided as multiples of ULN. The team grouped patients according to median TGA-IgA values: Group A included TGA-IgA>1 ≤ 5 × ULN; defined as “low-positive”, Group B (TGA-IgA > 5 < 10 × ULN; “moderate-positive”), and Group C, the controls). They were able to analyze the data of 281 children. Of 162 children in group A, they diagnosed celiac disease in 142 (nearly 90%), whereas they found normal duodenal mucosa in 20 group A children. The team diagnosed all 62 children (100%) in group B with celiac disease. Group C included 57 control subjects. EMA were undetectable in 31 (15%) of mucosal atrophy cases. On the receiver-operating characteristic curve, with the area under the curve equal to 0.910, a mean value of 1.7 ULN predicted mucosal damage with nearly 82% sensitivity and specificity. Based on their data, the team concludes that repeated low or moderate TGA-IgA values, under 5 ULN or 10 ULN, are good predictors of a celiac disease diagnosis. The team advises doctors treating symptomatic children with persistently low positive TGA-IgA titers to conduct an esophagogastroduodenoscopy, regardless of the patient's EMA status. Read more in the Journal of Pediatric Gastroenterology and Nutrition

Celiac.com 05/04/2021 - Immunoglobulin A tissue transglutaminase gives doctors a noninvasive way to spot celiac disease, but new research suggests that its sensitivity may be lower than estimated, making it a poor screening test, at least in asymptomatic patients. The reason comes down to verification bias, wherein a technique appears to have higher sensitivity and lower specificity than it actually does, because individuals who screen positive are more likely to have their disease confirmed by a follow-up small-bowel biopsy, while those who screen negative are unlikely to have a follow-up biopsy that could reveal missed celiac disease. That matters because the disparity could lead to missed celiac diagnoses, because some of those in the negative group could actually have celiac disease. "What you're missing from when you're calculating sensitivity is, what about the ones that are negative on the index test? Would they have been positive on that reference test? That's not even coming into your calculation because they're not getting that reference test," said Marisa Stahl, MD, a physician and researcher at the Children's Hospital Colorado Center of Celiac Disease in Aurora. Stahl was not involved in the meta-analysis, but commented on it in an interview. To determine whether the studies used by USPSTF may have overestimated sensitivity due to verification bias, Isabel Hujoel, MD, of the Mayo Clinic, Rochester, Minn., and colleagues conducted a meta-analysis, in which they reviewed those same nine studies to see the potential impact of verification bias. They then rated each study as being high, low, or unclear for possible verification bias. In all, they found five studies to be high risk. The only way to fully correct the bias is to run both IgA tissue transglutaminase (tTG) testing and small bowel biopsy on a complete or random sample of patients, and compare the sensitivity and specificity of IgA tTG with the preferred method small-bowel biopsy. But this is almost never done. Instead, when the U.S. Preventive Services Task Force concluded that evidence was insufficient for IgA tTG testing for celiac disease, it relied on a 2016 comparative effectiveness review of nine studies that estimated sensitivity at 92.6% and specificity at 97.6%. USPSTF remained noncommittal because of inadequate evidence surrounding the balance of benefit and harms of screening for celiac disease in asymptomatic individuals. Dr. Stahl was a bit shocked to see that the sensitivity was so much lower than has been traditionally accepted. The data clearly shows that "...the sensitivity is probably lower than what we oftentimes reference, and we should think more about the population of patients that could potentially screen negative and still have celiac disease," she said. Stahl suggests that the problem may be more common in adults, who have a higher incidence of seronegative Celiac disease, though there is no good data on that point, right now. Clearly reduced sensitivity of IgA tissue transglutaminase (tTG) testing is a big deal, and we're likely to hear more on this, so stay tuned. Read the full report in the Journal of Clinical Gastroenterology and the abstract pubmed.ncbi.nlm.nih.gov

Celiac.com 04/10/2021 - It was gratifying to learn, from a recent post to the Celiac Listserv, that some celiac-savvy medical practitioners are now ordering bone density testing as soon as a patient’s serology indicates celiac disease. This emerging standard of care is well rooted in the medical and scientific literature and constitutes a reasonable and appropriate strategy for the effective care and treatment of celiac disease patients. Investigators have been recommending this approach for more than a decade(1,2) and these recommendations are particularly important given the more recent data that showing a dramatic fracture rate among celiac patients that is seven times that of controls(3,4). Although the sensitivity of endomysium (EMA) and tissue transglutaminase (tTG) may be open to criticism, there can be little doubt that these tests are quite specific and usually reported as close to 100%. Simply put, almost everyone who has positive serological test results will be shown to have celiac disease. Thus, when an EMA or tTG test is positive for celiac disease it is very likely that the individual in question has, or soon will have, celiac disease. Although a controversial approach, some practitioners are even diagnosing celiac disease based on serology alone. Researchers have long known that celiac disease is associated with significant bone demineralization and increased risk of fractures(5). Relevant research also shows that therapeutic intervention in celiac patients can require a very different approach than with non-celiac patients(6-7) and there is considerable variation from one celiac patient to the next(1) which practitioners must also consider. Suspected causes of the increased bone disease and fracture risk include: reduced intestinal absorption area and compromised active transport of calcium across the intestinal barrier3; hyperparathyroidism, possibly as the result of cross reaction of endomysium antibodies with parathyroid tissues(8); autoimmune hyperthyroid disease, which is frequently found in association with celiac disease(9); excessive mineral release from the bones and excretion(3); vitamin D deficiency(10); along with a host of other celiac-associated possibilities. Each or many of the above factors are likely contributors to the unique needs of every newly diagnosed celiac patient. Even when bone density testing reveals metabolic bone disease, it does not reveal the exact nature of the underlying problem(3) and celiac disease patients with bone mineral losses often can not be predicted clinically(1) so testing is the only rational option. While a strict gluten-free diet will usually have a positive impact on bone density, that improvement falls far short of control values(11). Bone density values and trends will provide assistance in determining individual fracture risk, which is an important clinical consideration(2). Every person, regardless of their celiac disease diagnosis, is unique. It is especially important that each one should have early testing to determine their bone mineral status at diagnosis because of the very strong association between celiac disease and bone disease. Such test results enable health care providers to monitor their celiac patients’ bone health and fracture risk. Simply put, if we can not see where we started from, how can we tell how far we have come or whether we are moving in the right direction? Early bone density testing is the first step in therapeutic intervention. In many cases, coupled with follow-up testing, it will be the only intervention needed. In other cases, however, bone density testing will be the first step in a lengthy therapeutic process that may involve several changes in treatment as the individual progresses. Some patients may require magnesium supplementation as part of a therapeutic intervention for parathyroid disease(6). Others may need treatment for autoimmune thyroid disease which afflicts more than 12.9% of newly diagnosed celiac patients(12). Most celiac patients have been shown to have low vitamin D status(10) which, depending on a variety of factors, may indicate a need for vitamin D supplementation. Still others may require pharmacological interventions. Alert practitioners will, in keeping with the literature, order bone density testing. Abnormal results should identify concurrent bone disease and alert the practitioner to the need for further testing to determine the exact nature of the pathology/pathologies that may be at work. Regardless of the particular cause of bone disease or abnormality, bone density testing is the very first step in each of these interventions. Follow-up bone density testing will usually provide meaningful information to direct treatment and is especially useful when juxtaposed with initial test results. There can be little doubt that bone density testing is appropriate for newly diagnosed celiac disease patients. This practice is strongly advocated in the medical and scientific literature, and promises to mitigate the sometimes ghastly consequences of bone disease, demineralization, and degeneration that are too often found in association with celiac disease. Ultimately, such testing will not only improve quality of life for celiac patients, but in combination with appropriate supplementation, dietary, and pharmacological practices, this testing will save health care dollars through reduced needs for acute care. For these reasons, I was surprised to read that the insurance company of the person who posted that message to the celiac listserv had refused to pay for the bone density testing ordered by her health care practitioner on the basis of positive celiac serology. In the early days of endomysium and tissue transglutaminase testing, some insurance companies also failed to see that serological testing would one day save substantial sums by reducing the number of endoscopic biopsies required for a celiac diagnosis. My own diagnosis required three endoscopic biopsies. Similarly, it appears that at least one insurance company is overlooking the savings from acute care that they will accrue from the emerging standard of care in which bone density testing is ordered for all patients with positive celiac serology tests. One can only hope that they will soon recognize the real cash value such testing offers to health insurance providers. References: 1. Walters JR, Banks LM, Butcher GP, Fowler CR. Detection of low bone mineral density by dual energy x ray absorptiometry in unsuspected suboptimally treated celiac disease. Gut. 1995 Aug;37(2):220-4. 2. Pistorius LR, Sweidan WH, Purdie DW, Steel SA, Howey S, Bennett JR, Sutton DR. Coeliac disease and bone mineral density in adult female patients. Gut. 1995 Nov;37(5):639-42. 3. Fickling WE, McFarlane XA, Bhalla AK, Robertson DAF. The clinical impact of metabolic bone disease in coeliac disease. Postgrad Med J. 2001; 77:33-36 4. Vitoria JC, Arrieta A, Arranz C, Ayesta A, Sojo A, Maruri N, Garcia-Masdevall MD. Antibodies to gliadin, endomysium, and tissue transglutaminase for the diagnosis of celiac disease. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):571-4. 5. Marsh MN. Bone disease and gluten sensitivity: time to act, to treat, and to prevent. Am J Gastroenterol. 1994 Dec;89(12):2105-7. 6. Rude RK, Olerich M. Magnesium deficiency: possible role in osteoporosis associated with gluten-sensitive enteropathy. Osteoporos Int. 1996;6(6):453-61. 7. Hoggan R. 8. Kumar V, Valeski JE, Wortsman J. Celiac disease and hypoparathyroidism: cross-reaction of endomysial antibodies with parathyroid tissue. Clin Diagn Lab Immunol. 1996 Mar;3(2):143-6. 9. Kisakol G, Kaya A, Gonen S, Tunc R. Bone and Calcium Metabolism in Subclinical Autoimmune Hyperthyroidism and Hypothyroidism. Endocrine Journal Vol. 50 (2003) , No. 6 657-661 10. .Kemppainen T, Kröger H, Janatuinen E, Arnala I, Kosma VM, Pikkarainen P, Julkunen R, Jurvelin J, Alhava E, Uusitupa M. Osteoporosis in adult patients with celiac disease. Bone. 1999 Mar;24(3):249-55. 11. McFarlane XA, Bhalla AK, Robertson DA.Effect of a gluten free diet on osteopenia in adults with newly diagnosed coeliac disease. Gut. 1996 Aug;39(2):180-4. 12. Sategna-Guidetti C, Volta U, Ciacci C, Usai P, Carlino A, De Franceschi L, Camera A, Pelli A, Brossa C. Prevalence of thyroid disorders in untreated adult celiac disease patients and effect of gluten withdrawal: an Italian multicenter study. Am J Gastroenterol. 2001 Mar;96(3):751-7.