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    Will New Tests and Devices Change Celiac Diagnostics and Management?


    Jefferson Adams


    • Will new tests and devices change celiac diagnostics and diabetes management?


    Image Caption: Will new tests change the way we diagnose and treat celiac disease and diabetes? Photo: CC--AJC1

    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?


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    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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  • About Me

    Jefferson Adams is a freelance writer living in San Francisco. He has covered Health News for Examiner.com, and provided health and medical content for Sharecare.com. His work has appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate, among others.

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  • Related Articles

    Jefferson Adams
    Celiac.com 04/04/2017 - From 2009 to 2014, the number of people with celiac disease in the United States held steady, while the number of undiagnosed individuals fell by about half.
    Mayo Clinic researchers, reviewing information from National Health and Nutrition Examination Surveys, say the increase in diagnosis likely stems from better detection, better celiac disease awareness, and/or possibly from the rising popularity of gluten-free diets.
    The research team reviewed blood test results of more than 22,000 people over age of six years of age.
    Interestingly, while rates of celiac disease ready held steady, the number of people following a gluten-free diet without a celiac diagnosis more than tripled, to an estimated 3.1 million people.

    Source:
    AllergicLiving.com

    Jefferson Adams
    Celiac.com 08/07/2017 - The guidelines of the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition allow for diagnosis of celiac disease without biopsies in children with symptoms and levels of immunoglobulin A against tissue-transglutaminase (TGA-IgA) 10-fold or more the upper limit of normal (ULN), confirmed by detection of endomysium antibodies (EMA) and positivity for HLA-DQ2/DQ8.
    To validate this approach, a team of researchers recently performed a large, international prospective study. The primary goal was to see if the non-biopsy approach can identify children with celiac disease with a positive predictive value (PPV) above 99% in clinical practice. That means they want to make sure doctors can get it right at least 99 times out of 100 in the office. They also wanted to compare the performance of different serological tests and to see if the suggested criteria can be simplified.
    The research team included KJ Werkstetter, IR Korponay-Szabó, A Popp, V Villanacci, M Salemme, G Heilig, ST Lillevang, ML Mearin, C Ribes-Koninckx, A Thomas, R Troncone, B Filipiak, M Mäki, J Gyimesi, M Najafi, J Dolinšek, S Dydensborg Sander, R Auricchio, A Papadopoulou, A Vécsei, P Szitanyi, E Donat, R Nenna, P Alliet, F Penagini, H Garnier-Lengliné, G Castillejo, K Kurppa, R Shamir, AC Hauer, F Smets, S Corujeira, M van Winckel, S Buderus, S Chong, S Husby, S Koletzko; ProCeDE study group, P Socha, Bozena Cukrowska, H Szajewska, J Wyhowski, N Brown, G Batra, Z Misak, S Seiwerth, Y Dmitrieva, D Abramov, Y Vandenplas, A Goossens, MW Schaart, VTHBM Smit, N Kalach, P Gosset, JB Kovács, A Nagy, I Lellei, R KÅ‘bányai, K Khatami, M Monajemzadeh, K Dimakou, A Patereli, T Plato Hansen, R Kavalar, M Bolonio, H Kogler, G Amann, R Kosova, M Maglio, E Janssens, R Achten, P Frűhauf, H Skálová, T Kirchner, L Petrarca, FM Magliocca, F Martínez, V Morente, S Thanner-Lechner, M Ratschek, M Gasparetto, L Hook, D Canioni, C Wanty, A Mourin, K Laurila, M Vornane, V Nachmias Friedler, SL Morgenstern, J Amil Dias, F Carneiro, S Van Biervliet, S Vande Velde, H Banoub, S Sampson, AM Müller, A Ene, M Rafeey, and IAT Eftekhar Sadat. See the team’s individual affiliations below.**
    For their study, the team gathered data from consecutive pediatric patients 18 years or younger from 33 pediatric gastroenterology units in 21 countries. Patients all tested positive for TGA-IgA from November 2011 through May 2014, and all patients were on a gluten-containing diet. Local centers recorded patient symptoms, including measurements of total IgA, TGA, and EMA, and biopsy findings. The team recorded malabsorption when the children had chronic diarrhea, weight loss or insufficient gain, growth failure, or anemia.
    They directly compared central findings from 16 antibody tests (8 for TGA-IgA, 1 for TGA-IgG, 6 for IgG against deamidated gliadin peptides, and 1 for EMA, from 5 different manufacturers) 2 HLA-DQ2/DQ8 tests from 2 manufacturers, and histopathology findings from the reference pathologist. They based final diagnoses on local and central results. When all local and central results agreed for celiac disease, the team recorded those cases as proven celiac disease. Patients with TGA-IgA levels that were 3-fold or less below the ULN, but otherwise showed no indications of celiac disease, were classified as no celiac disease.
    The team conducted central histo-morphometry analysis on all other biopsies, and the cases were given a blind review. Inconclusive cases were regarded as not having celiac disease for better diagnostic accuracy and recruited 803 children for the study. They excluded 96 due to incomplete data, low level of IgA, or poor-quality biopsies, leaving 707 children, of whom 645 were diagnosed with celiac disease, 46 were found not to have celiac disease, and 16 had inconclusive results. The group was 65.1% female, and patients averaged 6.2 years old.
    Results from local laboratories of TGA-IgA 10-fold or more above ULN, a positive EMA result, and any one symptom identified children with celiac disease (n=399) with a PPV of 99.75 (95% CI, 98.61-99.99). The PPV was 100.00 (95% CI, 98.68-100.00) in 278 patients when only malabsorption symptoms were used instead of any one symptom.
    Inclusion of HLA analyses did not increase accuracy.
    Findings from central laboratories differed greatly for patients with lower levels of antibodies, but when levels of TGA-IgA were 10-fold or more the ULN, PPVs ranged from 99.63 (95% CI, 98.67-99.96) to 100.00 (95% CI, 99.23-100.00).
    This study confirms that children can be accurately diagnosed with celiac disease without biopsy. Diagnosis based on level of TGA-IgA 10-fold or more the ULN, a positive result from the EMA tests in a second blood sample, and the presence of at least 1 symptom could avoid risks and costs of endoscopy for more than half the children with celiac disease worldwide.
    HLA analysis is not required for accurate diagnosis.
    Source:
    Gastroenterology. 2017 Jun 15. pii: S0016-5085(17)35736-0. doi: 10.1053/j.gastro.2017.06.002.  
    **The members of the research team are variously affiliated with the Dr. von Hauner Children’s Hospital, Ludwig-Maximilian’s University Munich, Celiac Disease Center Heim Pál Children’s Hospital, Budapest and Dept. of Pediatrics, University of Debrecen, Hungary, University of Medicine and Pharmacy “Carol Davila” and National Institute for Mother and Child Health “Alessandrescu-Rusescu”, Bucharest, Romania, Institute of Pathology, Spedali Civili, Bresci, Italy, Dept. of Clinical Immunology, Odense University Hospital, Denmark, Dept. of Pediatrics, Leiden University Medical Center, the Netherlands, Dept. of Pediatric Gastroenterology and Hepatology, La Fe University Hospital, Valencia, Spain, Dept. of Pediatric Gastroenterology, Royal Manchester Children's Hospital, Manchester, United Kingdom, Dept. of Translational Medical Sciences & European Laboratory for the Investigation of Food-Induced Diseases, University Federico II, Naples, Italy, Center for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland, Dept. of Pediatric Gastroenterology & Hepatology, Children Medical Center, Tehran University of Medical Sciences, Iran, Dept. of Pediatrics, University Medical center (UMC) Maribor, Slovenia, Hans Christian Andersen Children's Hospital, Odense University Hospital, Denmark, Division of Gastroenterology, Hepatology and Nutrition, First Dept. of Pediatrics, Children's Hospitals "Agia Sophia", University of Athens, Athens, Greece, Gastroenterology Outpatient Clinic, St. Anna Children's Hospital, Medical University Vienna, Vienna, Austria, Dept. of Pediatrics, First Faculty of Medicine and General Teaching Hospital, Charles University, Prague, Czech Republic, Dept. of Pediatrics, Sapienza University of Rome, Italy, Dept. of Pediatrics, Jessa Hospital, Hasselt, Belgium, Dept. of Pediatric Gastroenterology, Addenbrookes Hospital, Cambridge, United Kingdom, Dept. of Pediatric Gastroenterology, Hepatology and Nutrition, Hôpital Necker-Enfants Malades, Paris, France, Dept. of Pediatric Gastroenterology and Nutrition, Hospital Universitari Sant Joan, Reus, Spain, Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel, Sackler faculty of Medicine, Tel Aviv University, Tel Aviv, Israel, Dept of Pediatrics, Medical University of Graz, Graz, Austria, Université Catholique de Louvain, IREC, PEDI, Cliniques universitaires Saint Luc, Brussels, Belgium, Dept. of Pediatric Gastroenterology, Hospital S. João, Porto, Portugal, Dept. of Pediatric Gastroenterology, Hepatology and Nutrition, Ghent University Hospital, Ghent, Belgium, Dept. of Pediatrics, St. Marien Hospital, Bonn, Germany, Queen Mary's Hospital for Children, Carshalton, United Kingdom, Department of Gastroenterology, Hepatology, Nutritional Disorders and Pediatrics, Pathology Department, Children's Memorial Health Institute, Warsaw, Poland, Pediatrics, Medical University of Warsaw, Pathomorphology, Pediatric University Hospital, Warsaw, Poland, Royal Manchester Children’s Hospital, Manchester, UK, Referral Center for Pediatric Gastroenterology and Nutrition, Children’s Hospital Zagreb, Institute of Pathology, Medical School University of Zagreb, Zagreb, Croatia, Russian Medical Academy of Continuing Postgraduate Education, Pathology, Kidz Health Castle, UZ Brusses, Brussel, Belgium, Pediatrics, Pathology, Leiden University Medical Center (LUMC), Hôpital Saint Vincent de Paul, Catholic University, Gastroenterology & Nephrology, Pathology, Heim Pál Children's Hospital, Budapest, Pediatric Gastroenterology, Hepatology &Nutrition, Children Medical Center, Tehran University of Medical Science and Mofid Children Hospital, Shahid Beheshti University of Medical Sciences, Pathology Unit, Children Medical Center Hospital Tehran, Division of Gastroenterology and Hepatology, First Department of Pediatrics, Children’s hospital «Agia Sofia», University of Athens, Clinical Pathology, Odense University Hospital, Department of Pathology, University Medical Center Maribor, Maribor, Slovenia, Pediatric Gastroenterology & Hepatlogy and David Ramos, Pathology Unit, La Fe University Hospital Valencia, St. Anna Children's Hospital, Department of Pathology, Medical University Vienna, Dept. of Translational Medical Sciences & European Laboratory for the Investigation of Food-Induced Diseases, University Federico II, Naples Italy, Pediatrics, Pathology, Jessa Hospital, Hasselt, Pediatrics and Adolescent Medicine, pathologist, Institute of Pathology, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic, Institute of Pathology, Ludwig Maximilian's University Munich, Munich, Germany, Pediatrics and Infantile Neuropsychiatry, Radiology, Oncology and Human Pathology, “Sapienza” University, Rome, Italy, Gastroenterology Unit, Pathology Unit, Hospital Universitari de Sant Joan de Reus, IISPV, URV, Pediatrics, Institute for Pathology, Medical University of Graz, Austria, Pediatric Gastroenterology, Hepatology & Nutrition, Pathology, Cambridge University NHS Foundation Trust, Addenbrookes Hospital, Cambridge, UK, Anatomo-Pathology, Hôpital Necker-Enfants Malades, Paris, France, Pediatric Gastroenterology, Pathology Unit, Université Catholique de Louvain, Cliniques universitaires Saint Luc, Brussels, Belgium, Centre for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland, Institute of Gastroenterology, Nutrition & Liver Diseases, Schneider Children's Medical Center, Department of Pathology, Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Israel, Hospital S. João, Porto, Portugal, Dept. of Pediatric Gastroenterology, Hepatology and Nutrition, Ghent University Hospital, Gent, Belgium, Queen Mary's Hospital for Children, Dept of Pathology, Epsom & St Helier University NHS Trust, Carshalton, UK, Department of Pathology, University of Bonn, Bonn, Germany, Histology Department National Institute for Mother and Child Health, Bucharest, Romania, and with the Liver & Gastrointestinal Research Center, Pathology Unit, Tabriz University of Medical Sciences.

  • Recent Articles

    Jefferson Adams
    Celiac.com 06/23/2018 - If you’re looking for a great gluten-free Mexican-style favorite that is sure to be a big hit at dinner or at your next potluck, try these green chili enchiladas with roasted cauliflower. The recipe calls for chicken, but they are just as delicious when made vegetarian using just the roasted cauliflower. Either way, these enchiladas will disappear fast. Roasted cauliflower gives these green chili chicken enchiladas a deep, smokey flavor that diners are sure to love.
    Ingredients:
    2 cans gluten-free green chili enchilada sauce (I use Hatch brand) 1 small head cauliflower, roasted and chopped 6 ounces chicken meat, browned ½ cup cotija cheese, crumbled ½ cup queso fresco, diced 1 medium onion, diced ⅓ cup green onions, minced ¼ cup radishes, sliced 1 tablespoon cooking oil 1 cup chopped cabbage, for serving ½ cup sliced cherry or grape tomatoes, for serving ¼ cup cilantro, chopped 1 dozen fresh corn tortillas  ⅔ cup oil, for softening tortillas 1 large avocado, cut into small chunks Note: For a tasty vegetarian version, just omit the chicken, double the roasted cauliflower, and prepare according to directions.
    Directions:
    Heat 1 tablespoon oil in a cast iron or ovenproof pan until hot.
    Add chicken and brown lightly on both sides. 
    Remove chicken to paper towels to cool.
     
    Cut cauliflower into small pieces and place in the oiled pan.
    Roast in oven at 350F until browned on both sides.
    Remove from the oven when tender. 
    Allow roasted cauliflower to cool.
    Chop cauliflower, or break into small pieces and set aside.
    Chop cooled chicken and set aside.
    Heat 1 inch of cooking oil in a small frying pan.
    When oil is hot, use a spatula to submerge a tortilla in the oil and leave only long enough to soften, about 10 seconds or so. 
    Remove soft tortilla to a paper towel and repeat with remaining tortillas.
    Pour enough enchilada sauce to coat the bottom of a large casserole pan.
    Dunk a tortilla into the sauce and cover both sides. Add more sauce as needed.
    Fill each tortilla with bits of chicken, cauliflower, onion, and queso fresco, and roll into shape.
    When pan is full of rolled enchiladas, top with remaining sauce.
    Cook at 350F until sauce bubbles.
    Remove and top with fresh cotija cheese and scallions.
    Serve with rice, beans, and cabbage, and garnish with avocado, cilantro, and sliced grape tomatoes.

     

    Roxanne Bracknell
    Celiac.com 06/22/2018 - The rise of food allergies means that many people are avoiding gluten in recent times. In fact, the number of Americans who have stopped eating gluten has tripled in eight years between 2009 and 2017.
    Whatever your rationale for avoiding gluten, whether its celiac disease, a sensitivity to the protein, or any other reason, it can be really hard to find suitable places to eat out. When you’re on holiday in a new and unknown environment, this can be near impossible. As awareness of celiac disease grows around the world, however, more and more cities are opening their doors to gluten-free lifestyles, none more so than the 10 locations on the list below.
    Perhaps unsurprisingly, the U.S is a hotbed of gluten-free options, with four cities making the top 10, as well as the Hawaiian island of Maui. Chicago, in particular, is a real haven of gluten-free fare, with 240 coeliac-safe eateries throughout this huge city. The super hip city of Portland also ranks highly on this list, with the capital of counterculture rich in gluten-free cuisine, with San Francisco and Denver also included. Outside of the states, several prominent European capitals also rank very highly on the list, including Prague, the picturesque and historic capital of the Czech Republic, which boasts the best-reviewed restaurants on this list.
    The Irish capital of Dublin, meanwhile, has the most gluten-free establishments, with a huge 330 to choose from, while Amsterdam and Barcelona also feature prominently thanks to their variety of top-notch gluten-free fodder.
    Finally, a special mention must go to Auckland, the sole representative of Australasia in this list, with the largest city in New Zealand rounding out the top 10 thanks to its 180 coeliacsafe eateries.
    The full top ten gluten-free cities are shown in the graphic below:
     

    Jefferson Adams
    Celiac.com 06/21/2018 - Would you buy a house advertised as ‘gluten-free’? Yes, there really is such a house for sale. 
    It seems a Phoenix realtor Mike D’Elena is hoping that his trendy claim will catch the eye of a buyer hungry to avoid gluten, or, at least one with a sense of humor. D’Elena said he crafted the ads as a way to “be funny and to draw attention.” The idea, D’Elena said, is to “make it memorable.” 
    Though D’Elena’s marketing seeks to capitalizes on the gluten-free trend, he knows Celiac disease is a serious health issue for some people. “[W]e’re not here to offend anybody….this is just something we're just trying to do to draw attention and do what's best for our clients," he said. 
    Still, the signs seem to be working. D'elena had fielded six offers within a few days of listing the west Phoenix home.
    "Buying can sometimes be the most stressful thing you do in your entire life so why not have some fun with it," he said. 
    What do you think? Clever? Funny?
    Read more at Arizonafamily.com.

    Advertising Banner-Ads
    Bakery On Main started in the small bakery of a natural foods market on Main Street in Glastonbury, Connecticut. Founder Michael Smulders listened when his customers with Celiac Disease would mention the lack of good tasting, gluten-free options available to them. Upon learning this, he believed that nobody should have to suffer due to any kind of food allergy or dietary need. From then on, his mission became creating delicious and fearlessly unique gluten-free products that were clean and great tasting, while still being safe for his Celiac customers!
    Premium ingredients, bakeshop delicious recipes, and happy customers were our inspiration from the beginning— and are still the cornerstones of Bakery On Main today. We are a fiercely ethical company that believes in integrity and feels that happiness and wholesome, great tasting food should be harmonious. We strive for that in everything we bake in our dedicated gluten-free facility that is GFCO Certified and SQF Level 3 Certified. We use only natural, NON-GMO Project Verified ingredients and all of our products are certified Kosher Parve, dairy and casein free, and we have recently introduced certified Organic items as well! 
    Our passion is to bake the very best products while bringing happiness to our customers, each other, and all those we meet!
    We are available during normal business hours at: 1-888-533-8118 EST.
    To learn more about us at: visit our site.

    Jefferson Adams
    Celiac.com 06/20/2018 - Currently, the only way to manage celiac disease is to eliminate gluten from the diet. That could be set to change as clinical trials begin in Australia for a new vaccine that aims to switch off the immune response to gluten. 
    The trials are set to begin at Australia’s University of the Sunshine Coast Clinical Trials Centre. The vaccine is designed to allow people with celiac disease to consume gluten with no adverse effects. A successful vaccine could be the beginning of the end for the gluten-free diet as the only currently viable treatment for celiac disease. That could be a massive breakthrough for people with celiac disease.
    USC’s Clinical Trials Centre Director Lucas Litewka said trial participants would receive an injection of the vaccine twice a week for seven weeks. The trials will be conducted alongside gastroenterologist Dr. James Daveson, who called the vaccine “a very exciting potential new therapy that has been undergoing clinical trials for several years now.”
    Dr. Daveson said the investigational vaccine might potentially restore gluten tolerance to people with celiac disease.The trial is open to adults between the ages of 18 and 70 who have clinically diagnosed celiac disease, and have followed a strict gluten-free diet for at least 12 months. Anyone interested in participating can go to www.joinourtrials.com.
    Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre.

    Source:
    FoodProcessing.com.au