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    FDA Approves First Fully Automated Gliadin Tests with Deamidated Peptides for Celiac Disease


    Jefferson Adams
    Image Caption: Important new FDA approval of celiac disease testing.

    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.


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    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.

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    Guest Jeff Kelly

    Posted

    Lowest number of false positives? I don't see how this beats the stool antibody tests developed by Kenneth Fine, MD of Dallas, Texas and his Enterolab.

    There simply AREN'T any really good antibody tests besides his yet it seems. Physicians and patients need to recognize this and Physicians especially need to stop living in a fantasy world on accurate tests for Celiac.

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    Blood test are not accurate. Daughter diagnosed 4 years ago from a biopsy and then the blood test to confirm. I did a blood test and I was negative. My mother was negative as well. However, 3 years down the road, my mother had genetic testing done to see if she had the gene(s) for celiac. She does! She has both the genes. Resulting in ME having it 100%. My point here is blood test are so not accurate.

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    Blood test are not accurate. Daughter diagnosed 4 years ago from a biopsy and then the blood test to confirm. I did a blood test and I was negative. My mother was negative as well. However, 3 years down the road, my mother had genetic testing done to see if she had the gene(s) for celiac. She does! She has both the genes. Resulting in ME having it 100%. My point here is blood test are so not accurate.

    Your mother can have the gene and not develop the disease, and the same goes for you. The blood tests they do is to see if you in fact have the disease, not the gene.

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    Guest Reeny

    Posted

    Test does not state whether person needs to be consuming gluten prior to testing. What's the truth of the matter? Where can I find solid facts? Thanks.

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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

    Scott Adams
    Authors Rivabene R. Mancini E. De Vincenzi M.
    Source Biochimica et Biophysica Acta - Molecular Basis of Disease. 1453(1):152-160, 1999 Jan 6.

    Abstract: Coeliac disease (celiac disease) is an inflammatory disorder of the upper small intestine in which gluten acts as an essential factor in its pathogenesis. Although it is generally accepted that cereal protein activation of the immune system is involved in celiac disease progression, a non-immunomediated cytotoxic activity of gliadin-derived peptides on the jejunal/duodenal tract cannot be excluded. In this work, considering that (a) little has been reported about the intracellular metabolic events associated with gliadin toxicity, and ( an important role for free radicals in a number of gastrointestinal disease has been demonstrated, we investigated the in vitro effects of gliadin-derived peptides on redox metabolism of Caco-2 intestinal cells during a kinetic study in which cells were exposed to peptic-tryptic digest of bread wheal up to 48 h. We found that the antiproliferative effects displayed by gliadin exposure was associated with intracellular oxidative imbalance, characterized by an increased presence of lipid peroxides, an augmented oxidized (GSSC)/reduced (GSH) glutathione ratio and a loss in protein-bound sulfhydryl groups. Significant structural perturbations of the cell plasma membrane were also detected. Additional experiments performed by using the specific GSH-depleting agent buthionine sulfoximine provide evidence that the extent of gliadin-induced cell growth arrest critically depends upon the basal redox profile of the enterocytes. On the whole, these findings seem to suggest that, besides the adoption of a strictly gluten-free diet, the possibility for an adjuvant therapy with antioxidants may be considered for celiac disease patients. © 1999 Elsevier Science B.V. All rights reserved. [References: 38]

    Jefferson Adams
    Celiac.com 10/01/2009 - Antibodies to deamidated gliadin offer a promising new tool in the diagnosis of celiac disease. A team of researchers recently set out of examine serodiagnosis of childhood celiac disease assay of antibodies against deamidated gliadin.
     The research team was made up of Christian Prause, Thomas Richter, Sibylle Koletzko, H. Holm Uhlig, Almuthe C. Hauer, Martin Stern, Klaus-Peter Zimmer, Martin W. Laass, Christian Probst, Wolfgang Schlumberger, and Thomas Mothes.
    Their results show that the ELISA for gauging IgG antibodies to deamidated gliadin-analogous fusion peptides (GAF3X) performs better in children than does the ELISA for gauging antibodies against native gliadin, and compares favorably to results for IgA antibodies against tissue transglutaminase (IgA-anti-tTG).
    By combining investigations of IgG antibodies to GAF3X (IgG-anti-GAF3X) with IgA-anti-tTG, a significantly higher number of children were positively confirmed to have celiac disease, or to be free of celiac disease.
    The new IgG-anti-GAF3X ELISA detected three instances of IgA deficienc, along with two cases of silent celiac disease, in addition to improving diagnosis of children under 2 years of age.
    It will be interesting to see where these enhanced approaches for diagnosing celiac disease will take us. Much research certainly supports the benefits of early diagnosis and treatment, especially with respect to the development of conditions associated with untreated and/or latent celiac disease. Even the ability to diagnose a new category of gluten intolerant individuals might gain steam from more refined screening techniques.
    Source:
    Annals of the New York Academy of Sciences - Volume 1173 Issue Contemporary Challenges in Autoimmunity, Pages 28 - 35


  • 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.
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    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.
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    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.
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    Roxanne Bracknell
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    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. 
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    Advertising Banner-Ads
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    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. 
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    Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre.

    Source:
    FoodProcessing.com.au