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

    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.

    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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    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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    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 earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

  • 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


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    Okay, thanks. Re: MTHFR - I don't really know yet... I only started reading about it yesterday and it is pretty overwhelming. But it does seem to be common advice that if you have a close relative with it you should be tested, and I guess having 2 copies of the "C" variant, as my sister has, is the "worst" variety of it.  It came to light for her when she was going through infertility and miscarriages.  They discovered that her homocysteine was high, which led to the MTHFR testing. So that is one thing I know I would then want to proceed to do, if I do have it - get my homocysteine tested. My dad died of early-onset Alzheimer's, and apparently there is a link between high homocysteine as well as the MTHFR mutation and Alzheimer's. It also seems like it would be worth knowing if I have it since it could be the cause of my lower levels of B12. And I guess maybe I would need to start taking methyl-folate? I mean, to answer your question, I am not entirely sure what I will do if I do have it.   Probably read a lot more about it... and take supplements like methyl-folate if I really think I need to.  Check my homocysteine & control that if I need to, hopefully to lower my risk of Alzeheimer's.  It seems like a frustrating area because there appear to be limited official medical websites that really even talk much about it (so far).  I have found one article on the NIH that focuses on the link with high homocysteine. I already eat a very healthy diet.  Whole grains, lots of fruit & veg, mostly organic.  I am a vegetarian except for very rare seafood. I avoid processed food and, above all, foods with added sugar...  To me, sugar is by far the worst culprit in the SAD.  I think RA has been ruled out by my 2 negative Rheumatoid Factor tests (one done several years ago, one just this year at my physical).  Also, the way this started in my elbows, and was really only there for years, is just... weird... and definitely doesn't really fit with arthritis.  And there is no swelling to speak of, just mild pain - sometimes aching, sometimes burning, sometimes sharp...  It may or may not fit with any systemic diagnosis versus a mechanical one, but nowadays I do also have pain in my hands, feet, and knees.  So then I think, well maybe it is/was something systemic, but it was worse in my elbows for some mechanical reason but now has progressed elsewhere.  I thought Crohn's was just digestive?  (Of course, many people think that of celiac.)  So I haven't really investigated that one much. My ANA was retested and is back down to "negative," so I think that pretty much rules out lupus.  I believe fibromyalgia is still on the table. Anyhow....  Your point is nonetheless taken.  I do want to rule out celiac and go from there.  At this point I'd sure love to find out it is something I could control through my diet!
    Hello, I've been suffering abdominal issues for about two months now. I've been having minor pain and a lot of pressure in my left abdomen. It feels almost like someone is inflating a balloon on my left side from below the belly button to just below the ribs. At first my doctor diagnosed it as diverticulitis, and put me on antibiotics, however a CT scan was never done. I was advised to stuck to a liquid diet followed by soft foods. I did start to feel better so I tried eating some pasta and toast and started to feel the pain and pressure again. My doctor then put me on stronger antibiotics and had me go back to the liquid and soft foods diet. Again I started to feel better and added in pasta and toast. Just like the first time the pain and pressure came back. My doctor then ran more bloodwork looking for other problems, including TGG IGA and TGG IGG. The TGG IGA came back <1.2 (negative), the TGG IGG came back 8.3 weak positive. My doctor thought that could point to potential celiac and ordered two more tests to look for celiac (I'm not sure which tests) and advised me to cut out gluten while waiting for the results.  I started researching celiac a little bit which is how I ended up here. I found a few things interesting. In the past 15 years I was diagnosed and treated for IBS, acid reflux, and chronic daily headaches with migraines. From the little research I've done it looks like all those could potentially be related to celiac. I'm anxiously awaiting the results from the new bloodwork, and hoping that I may be on the road to recovery! 
    For like $100 more, add the DGP IgA test as well.  The EMA is expensive because it is labor intensive (lab), so consider skipping that test.   Why find out if you have the MTHFR gene?    What is that knowledge going to do for you?  I have probably have the MTHFR gene.  My B-12 and Folate used to be off the chart when I was consuming soy milk that was fortified with cheap unmethylated forms of vitamins.    (I used soy milk before my celiac diagnosis because I was lactose intolerant).  I ceased all vitamin supplements and dropped any foods that were enriched  (or you can purchase more expensive methylated versions if you want to supplement) and those levels dropped down to normal levels.  I found that If I ate a normal healthy and varied diet and healed from celiac disease, I do not need supplements.   It appears that I was not able to process unmethylated vitamins because I might the MTHFR gene.  Just a theory.   Knowing I have the gene?  What is that going to do for me?  Will it change my behavior or save me from a new illness?  Can my doctor formulate treatments based on that knowledge?  Can he manipulate my genes?  NOT YET.  This might be beneficial in the future, but science is not there yet.  Just lots of websites trying to sell you vitamins.  Believe me, I have a family full of Autistic family members, so the MTHFR topic is of interest to me. Consider ruling out celiac disease first, address other issues that can impact joints like RA or Crohn’s), then eat a healthy diet that may or may not include gluten or processed food.  I have a friend who is on week three of the Whole 30 diet.  She ruefully confessed that she is feeling so much better.  In a few weeks, she will add foods back in that might be giving her issues.  I think she realizes that her Standard American Diet is not the healthy way to go.  Although she is happy about feeling significantly better, she is sad because she knows that she is going to have to give up all that junk food which seems to be making her sick.  I hope she moves forward because good health is priceless.      
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