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Showing results for tags 'Diagnostics'.
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Standardizing Celiac Disease Diagnostics
Jefferson Adams posted an article in Diagnosis, Testing & Treatment
Celiac.com 10/23/2023 - A recent study conducted by a team of US investigators is shedding light on the use of European thresholds for diagnosing celiac disease in North America. This study seeks to determine how often biopsies are performed on children who are considered at high risk for celiac disease based on common diagnostic tests, yet meet the criteria for non-biopsy diagnoses according to European standards. Dr. Denis Chang, the study's lead author, discussed the trial's design and its implications for celiac disease diagnostics in North America during an interview with HCPLive at the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) 2023 Annual Meeting in San Diego. Celiac disease is an autoimmune disorder that affects the small intestine and is triggered by the consumption of gluten, a protein found in wheat, rye, and barley. The gold standard for diagnosing celiac disease is through an endoscopy, which involves taking biopsies to confirm the damage caused by gluten. However, serology, or blood testing, has become a game-changer in the diagnostic process. It helps identify individuals who require an endoscopy based on a positive blood test, typically the tissue transglutaminase (tTG-IgA) test. While tTG-IgA is a reliable biomarker, it is not infallible and can yield false positives or negatives. In 2012, European colleagues established guidelines that allow for a celiac disease diagnosis in some cases where a highly positive tTG-IgA result is combined with another positive blood marker, EMA IgA. These guidelines initially included genetic risk and symptoms but no longer do. In contrast, North American guidelines have not incorporated these standards, partially due to the wide array of diagnostic assays used to identify celiac disease, each with its own methodology. Dr. Chang also emphasizes the concern of potentially overlooking other diagnoses by not conducting an endoscopy, such as eosinophilic esophagitis, which is commonly seen in celiac patients. In an ideal world, a standardized and widely accepted diagnostic assay strategy would simplify the diagnostic process and potentially pave the way for developing new clinical therapies for celiac disease. Currently, there are no FDA-approved drugs for treating celiac disease, and the most promising agents in development are primarily intended for adult patients. Dr. Chang explained that an alternative diagnosis method could help expand the pool of individuals, both providers and patients, who can collaborate to advance celiac disease research and treatment options. Additionally, it could offer clarity for patients who have received a presumed celiac disease diagnosis based solely on high blood markers, without undergoing a biopsy. This investigation into the use of European diagnostic thresholds in North America is a significant step toward streamlining the diagnosis of celiac disease. See more at the Conference|North American Society For Pediatric Gastroenterology, Hepatology & Nutrition -
Celiac.com 06/08/2023 - For people who suspect they have celiac disease, an accurate diagnosis is crucial for managing health and making informed dietary choices. Traditionally, the gold standard for celiac diagnosis has involved a gluten challenge, where individuals are required to consume gluten-containing foods to induce disease activity. However, this approach can be burdensome and time-consuming. Now, a new study conducted at two US centers has shed light on new biomarkers that could help to rapidly improve the way celiac disease is diagnosed and researched. The Research Team The research team included Maureen M. Leonard, Jocelyn A. Silvester, Daniel Leffler, Alessio Fasano, Ciarán P. Kelly, Suzanne K. Lewis, Jeffrey D. Goldsmith, Elliot Greenblatt, William W. Kwok, William J. McAuliffe, Kevin Galinsky, Jenifer Siegelman, I-Ting Chow, John A. Wagner, Anna Sapone, and Glennda Smithson. They are variously affiliated with the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, Massachusetts; the Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts; the Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Boston Children’s Hospital, Boston, Massachusetts; the Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts; the Department of Medicine, Columbia University Medical Center, New York, New York; the Department of Pathology, Boston Children’s Hospital, Boston, Massachusetts; Invicro, A Konica Minolta Company, Boston, Massachusetts; and the Benaroya Research Institute at Virginia Mason, Seattle, Washington. A Randomized Double-blind Trial In a randomized, double-blind trial, the team enrolled 14 adults with biopsy-proven celiac disease. The participants were divided into two groups and assigned to consume either 3 grams or 10 grams of gluten per day for a period of 14 days. The primary objective was to assess the changes in villous height: crypt depth (Vh:celiac disease), a key histological marker of celiac disease activity. However, the study also aimed to explore other biomarkers that could potentially supplement or even replace histology as a diagnostic tool. The results of the study were largely encouraging. All of the biomarkers assessed showed changes in response to gluten challenge, demonstrating their potential for evaluating disease activity. However, the time to reach maximal change, the magnitude of change, and the gluten dose-response relationship varied across different biomarkers. Notably, Vh:celiac disease, a measure of the structural integrity of the small intestine, VCE enteropathy score as assessed by video capsule endoscopy, enzyme-linked immune absorbent spot (ELISpot), gut-homing CD8 T cells, intraepithelial leukocytes, and gluten-specific CD4 T cells, all demonstrated significant changes only at the higher gluten dose of 10 grams. However, symptoms reported by the participants, and plasma interleukin-2 (IL-2) levels, increased significantly or near significantly at both gluten doses. Interestingly, IL-2 appeared to be the earliest and most sensitive marker of acute gluten exposure. Conclusions These findings can help to improve celiac disease diagnostics, by identifying modern biomarkers that are sensitive and responsive to gluten exposure, this study offers the possibility of less invasive and shorter-duration gluten challenges. This would not only ease the burden on individuals undergoing diagnostic testing but also streamline celiac disease research, enabling more efficient and precise investigations. The potential benefits of these novel biomarkers extend beyond diagnostics. They could also play a crucial role in monitoring disease activity, assessing treatment responses, and even exploring the effects of gluten on individuals who are at risk of developing celiac disease. While this study represents a significant step forward, further research is needed to validate and refine the biomarkers. Future studies may investigate their utility in larger populations and explore their correlation with long-term clinical outcomes. This study shows the potential for modern biomarkers to improve celiac disease diagnostics. By providing a preliminary framework for the rational design of gluten challenge protocols, this work brings us one step closer to more efficient and patient-friendly diagnostic approaches for celiac disease. Stay tuned for more on this and related stories. Read more in Gastroenterology -
Celiac.com 06/26/2007 - The results of a study recently published in the online science journal Nature Genetics have revealed a previously unknown genetic risk factor for celiac disease. An international team of researchers set out to study the genetic causes of intestinal inflammatory disorders. When the study began, it was well known that individuals with celiac disease have specific tissue types that identify wheat proteins. Why healthy individuals with the same tissue type failed to develop celiac symptoms or celiac disease remained unknown, and was a key question the team set out to answer. The team was led David van Heel, Professor of Gastrointestinal Genetics at Queen Mary, University of London. The Human Genome Project and the Hap Map Project played key support roles in the study. The results show that a protective DNA sequence in a specific gene segment, generally found in healthy individuals are missing in people with celiac disease. The research team evaluated genome data of 778 individuals with celiac disease and 1,422 controls non-celiacs within the British, Irish and Dutch populations. Key DNA Sequence Missing in Celiacs Researchers discovered that, compared to people with celiac disease, healthy people more commonly have a DNA sequence in the interleukin-2 and interleukin-21 gene region that protects against celiac disease. Interleukin-2 and interleukin-21 are cytokine proteins that are secreted by white blood cells, and which control inflammation. In people with celiac disease, the protective DNA sequence most likely leads to lesser amounts of these cytokines being produced, which weakens the defense against intestinal inflammation. Breakthrough in Better Understanding Risk Factors for Development of Celiac Disease About 1 in 133 people develop the disease, but, so far, predicting those at risk to develop the disease has been haphazard at best. Present methods of genetic testing can only narrow down the search to about 30% of the general population. These results give doctors a means to discover what further genetic risk factors leave people vulnerable to developing celiac disease. Queen Mary, University of London Press Release - Public release date: 10-Jun-2007 health writer who lives in San Francisco and is a frequent author of articles for Celiac.com.
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Celiac.com 09/11/2017 - The FDA has granted clearance for Immco Diagnostics' ELISA for celiac disease, and for Roche's Benchtop Analyzer. What does that mean? Immco's test is conducted as a solid phase immunoassay and is intended for the qualitative or semiquantitative detection of IgA or IgG antigliadin antibodies in human blood, and thus to aid in diagnosing patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings. In other important diagnostic news, a benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical was among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency. The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument platform, as well as the Cobas HbA1c test. The fully automated and self-contained Cobas b 101 uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA. The Cobas HbA1c is an in vitro diagnostic test for detecting the presence of glycate hemoglobin, which develops when hemoglobin joins with glucose in the blood, becoming 'glycated'. By measuring glycated hemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. The HbA1c assay is designed for use with the Cobas b 101 platform, which is not a portable home test, but is intended for a clinical laboratory or point-of-care setting. Other instruments receiving FDA clearance in July include a new flow cytometer from Becton Dickinson; an expanded version of Bruker's MALDI Biotyper; and expanded indications for BioMérieux's Vitek MS MALDI-TOF Mass Spectrometery System. The FDA recently cleared the Maglumi 2000 automated immunoassay analyzer from Shenzhen New Industries Biomedical, which uses chemiluminescent technology for running IVD tests on clinical serum samples. The firm's Maglumi 2000 TSH assay for the quantitative determination of thyroid-stimulating hormone in human serum also received 510(k) clearance. The assay is for diagnosing thyroid disorders. These are just a few of many new tests and analysis devices that are changing the way doctors diagnose and manage celiac disease, diabetes, and other diseases. Look for tests like this to have a profound influence on the way diseases are diagnosed and managed in the future. Read more: 360dx.com -
Celiac.com 02/15/2012 - At the American College of Gastroenterology (ACG) 2011 Annual Scientific Meeting held in Washington, DC, Caris Diagnostics, a leader in anatomic pathology services, presented 15 abstracts highlighting new findings that reflect and expand Caris' commitment to gastrointestinal disease research. Highlights from the presentation include two studies, in particular. The first study, "High Prevalence of Celiac Disease in Women With Young Onset Collagenous Colitis," found that young women with collagenous colitis are eight times more likely than the general population to have celiac disease. That study was authored by Ahmed Bedeir, MD, Bhaskar Ganguly, and Mukunda Ray, MD, PhD. As Dr. Bedeir's finding is gleaned from the largest series of young patients with collagenous colitis ever reported, the study team recommends that women age 40 or younger who have a diagnosis of collagenous colitis also undergo an EGD with duodenal biopsies to exclude concurrent celiac disease. The second study, "Seasonal Patterns in Eosinophilic Esophagitis: An Analysis by Month of Diagnosis and Month of Birth," showed that, contrary to previous suggestions derived from smaller series, there was no evidence of monthly or seasonal variation even within known regions with diverse climates among our 10,000 patients with eosinophilic esophagitis. That study was authored by Jennifer M. Hurrell, DO, Amnon Sonnenberg, MD, and Robert M. Genta, MD, FACG. Regarding Caris' commitment to gastrointestinal disease research, Richard H. Lash, MD, Chief Medical Officer for Caris says that the "establishment of the Caris Research Institute as a structure for promoting and carrying out research has again generated a strong presence at the annual ACG meeting in Washington, D.C," adding that Caris remains "committed to leveraging our tremendous database and academic talent to answer important questions in the field of gastroenterology and are honored to have the opportunity to present our findings at ACG 2011." Source: http://www.carislifesciences.com/news/caris-diagnostics-presents-research-at-2011-annual-meeting-of-the-american-college-of-gastroenterology/ -
FINALLY! A call from the GI doc's office (8/22) and the nurse tells me "it looks like you may have a mild case of Celiac Disease; try a gluten free diet for a few weeks to see how you feel." LOL I asked her to send me a copy of my results for my records, which arrived yesterday (8/25). I was thinking that since this office didn't seem to know much about Celiac Disease, that maybe they didn't really know how to interpret the test results, and that by looking at them myself I'd see definitive proof. Not so much. They ran a Celiac Disease Comprehensive Panel, a Celiac Disease HLA DQ Assoc., and also Folate, Serum, and Vitamin B12 tests. Test Results: Deamidated Gliadin Abs, IgA.......1.2 (range 0.0-10.0) Deamidated Gliadin Abs, IgG.......0.7 (range 0.0-10.0) t-Transglutaminase (tTG) IgA.....0 (negative 0-3) t-Transglutaminase (tTG) IgG.....1 (negative 0-5) Endomysial Antibody IgA............Negative Immunoglobulin A, Qn, Serum......199 (neg 70-400) Folate (Folic Acid), Serum..........>24 (ref. int. >5.4) Vitamin B12.............................634 (ref. int. 211-911) Celiac Disease HLA DQ Assoc DQ2 Negative DQ8 Positive So the Celiac Comprehensive panel shows normal. I have one of the genes, and high folic acid. What the heck does this mean? I was still eating gluten when the blood draws were done, but I would have to say it was more of a 'gluten light' diet, as I do tend to steer away from the foods that I suspect are making me ill. So perhaps these are false negatives? The labs were sent to LabCorp, and I have read over and over that Prometheus and IMMCO are the best labs to send tests to since they know what to look for. Could that be the problem? Or do I now face the fact that I do not have celiac disease, and start over from square one to figure out what is wrong with me? My GI doc was ready to label me as IBS after my colonoscopy, until I pushed for the rest of the celiac disease panel, that is. I plan to continue with the gluten-free diet, but if I'm not Celiac, I fear I will let myself cheat, thinking "oh it won't hurt me, I'll just have a tummy ache" (even though that's not all that happens). I'm just really at a loss here..........I want to be well, and stop spinning my poor, tired, achy wheels.
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I had a follow up with my GI doc on Thursday, and he said that everything is 'normal' (colonscopy/biopsy, stool samples, blood work). We talked about the high values on some of my previous blood results and he said it was really nothing to worry about, but that we could do testing for B12/Folic acid levels. I pushed for the rest of the Celiac Panel blood tests, and his response was that the TtG IgA was the most sensitive, but that we would go ahead and do the rest of them anyway. (Gee, thanks. Why didn't we do them all in the first place?) He also mentioned gene testing, but that he'd have to research it since he didn't know much about it. His MA came in to do the blood draw, and told me she thought she'd just go ahead and take two vials of blood since she didn't know how many they needed - they'd never ordered these particular tests before. This tells me that this doc A) has never dx'd or possibly even treated a Celiac patient before and he's not terribly knowledgeable about it. So I sit here waiting for test results. Feeling worse. Not so much in my gut, although that has been somewhat troublesome over the last few days (as usual). Now I have something new. Joint pain. It started a week or so ago with me waking up one morning with my jaw locked into place (right side). I had TMJ in my late teens, but it was primarily the left side that was affected, and it never hurt like this or locked up completely. After some gentle maneuvering and a loud pop, I managed to unlock it and get it moving. It's been painful ever since, and has locked momentarily on a daily basis - I'm always able to get it moving again with a little help. Knees and hips are not happy either. There's been what I would call a low grade pain in both knees and both hips for probably two weeks now. But yesterday? Yesterday was BAD. I felt kind of like a 98 year old woman might feel - or maybe I could liken it to being hit by a truck? I don't know, I just know it HURT. And the pain felt like it was deep in my bones. I fell asleep around 4pm yesterday afternoon, and napped off and on until around 10pm. Then I got up, ate something, and went to bed and slept until around 9:30 this morning. We're looking at almost 16 hours of sleep! When I got up this morning, my knees & hips were only slightly pained, but the lower half of my back felt like my vertebrae were fused together. I've also been running a low grade fever for at least a week. Haven't seen it go above 100.1, so I don't know how concerned (if at all) to be about it, but it seems too coincidental that all these things started happening at about the same time. I also feel like my brain fog is getting worse. I've noticed I'm having trouble with remembering words for things. Things that come up in regular conversation. I'll go to ask my husband or my daughter "Do you seen the.............." and can't remember the word for the thing that I'm looking for. This morning I started a cup of coffee without putting the cup under the spout (single serve coffee machine). I just stood there and watched it pour into the drip tray. My husband is actually encouraging me to start the gluten free diet (tomorrow), but I feel like I should wait to make sure my GI actually ran all the tests this time around. But part of me just doesn't care. I just want to feel better. I don't know if my husband actually thinks it will help me to feel better, or if he's just tired of hearing me complain. I'm trying not to complain at all around him, because I feel like he doesn't want to hear it and thinks I'm being over dramatic, but it's not easy. I'm rambling.......so I guess that's it for tonight.
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Got a phone call from the GI doc's office with test results from the stool samples and my colonoscopy biopsies. "Everything looks normal; no indication of parasites or colitis. Follow ups are usually scheduled for 4-6 weeks after the colonoscopy." HUH?? All we've done is rule out some pretty bad stuff (for which I am quite grateful, don't get me wrong!). I still feel like crap, and now I need to wait 4-6 weeks before we talk about anything else? I pushed for an earlier follow up appointment, telling the nurse, well we still haven't figured out the problem. She found me a slot for next week. So I'll be asking for the remainder of the Celiac Panel bloodwork to be done.......but I don't know what else from there. I'm debating going back to my primary care doc to have additional bloodwork done to check hormone levels and vitamin/mineral levels. But maybe that would be wasting my time. Maybe I should just go back to gluten free and be done with this needle in a haystack hunt. *SIGH* I don't know what to do..........
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Mine is wearing thin. I still don't have test results from the stool samples, and don't expect biopsy results until early next week sometime. It's been really hard to sit around and NOT dwell on the possibilities. And if those come back negative, what next? I still need to address having the rest of the Celiac Panel done (they only tested for tTG IgA), but other than that, and asking about some of the 'high' reports on my CBC, I'm not sure what the next steps are. I just know I'm not feeling any better. Gas, cramping/abdominal pain, and bloating have been present every day since the scope, in varying degrees. Night sweats have been prevalant this week - actually had to get up and change my night clothes twice this week. I tell ya, I'm ready to call it quits on the testing and just go gluten-free again. And I haven't even been through that much compared to some here. I don't feel like I can give up on the testing just yet though. I'd like to have vitamin deficiency and/or allergy testing done if I can get the doc to do it. I guess I'm just tired of waiting, and not knowing. I don't feel like I've gotten anywhere with this stuff. Sorry for the pity party.........I'm just tired and frustrated. TTFN
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This is intended to show the lighter side of my experience with having a colonoscopy. Please bear in mind it was NOT funny as I was going through it, but in retrospect, it's hilarious to me. I hope you find amusement in it as well. First of all, let me say that I was terrified - TERRIFIED - of having this done. Other than a skull fracture when I was 4yo and having a baby, I've never been hospitalized or had any type of procedure done for anything. So I was freaked out about the prep. I was freaked out about the anesthesia, and I was freaked out about the procedure itself. And now I feel a little stupid. In preparation for this, Sunday's diet consisted of coffee, water, Sprite, apple jello and chicken broth. Oh, and somewhere in there was a lemon flavored italian ice thingy. Mmmmmm.........good. [sarcasm] The hubby and the kid had Long John Silvers for dinner and ate it in front of me. Now I'm no huge fan of the greasy-everything-tastes-like-fish food there, but I never wanted that greasy-everything-tastes-like-fish food so bad in my life. I was STARVING. Then came MoviPrep. Whoever posted that "Funny Rendition of a Colonoscopy" on the boards here - that guy that wrote it had it exactly right. When I picked up this prescription from the pharmacy, I didn't exactly think microwave oven, but 'chinese takeout for a family of three' sure did cross my mind, and not because I was hungry. Sunday, 5pm I mix up my first dose of MoviPrep. You never realize how much liquid 1 liter really is until you have to down the whole thing in an hours time. I thought I was going to float away. And no sooner did I finish the last swig of that first liter of swill, I was running - RUNNING - for the bathroom. And I didn't come out of there for more than ten minutes at a time until well after midnight. The reference to 'rocket launcher' in the above story is absolutely correct. Sunday, 9pm I somehow managed to finish the second liter of MoviPrep, but still couldn't come out of the bathroom for more than 10 minutes or so at a time. (Incidentally, I discovered that MoviPrep used to have another name - GoLightly. Someone decided that was a terribly inaccurate name for it and changed it.) Sunday, Midnight I'm exhausted and want to sleep. But I'm scared to. There was so little warning of needing to visit the bathroom, I was terrified of falling asleep in my own bed. I was sure if I went to sleep, I wouldn't wake up until it was too late. (I even had some concerns that I might have a problem in the operating room while I was knocked out, and envisioned my doctor in a big biohazard suit - my family got a giggle out of that when I shared that with them). So I lay there, watching TV until around 2am, and decide if I have any hope of getting up in the morning on time that I better go lights out. With only one more visit to the bathroom at around 3am, I somehow made it through the night, and even got a little bit of sleep. Night. Ha. I was up at 5:15 to get ready to go to the hospital. That wasn't even a nap for me. So.........I get all checked in for the procedure and go in to prep. I put on the stupid gown that allows easy access to your backside and settled onto the gurney. I was given a heated blanket (a nice touch, since it was COLD in there) and a lovely pair of no-slip socks (mint green colored, in case you're wondering) and jabbed with an IV (back of my hand - OUCH). Oops! Almost forgot about the lovely hair cap! I was stylin'. I get wheeled into the operating room and see the gigantic monitor (couldn't see what it was displaying really, as I had to leave my glasses behind and I'm fairly blind without them) and thought "That's almost the size of my living room TV - why do they need to see my innards THAT big?" The doctor announces he's ready, and a nurse says to me "You're going to start feeling like you've had one too many margaritas" to which I replied "I already feel like that......" And I was down for the count. Don't remember a THING until I woke up in recovery, and even some of those details are sketchy. After waking up, I am told that everything looks fine, except that I have internal hemorrhoids (gee, wonder why that is? MoviPrep maybe??? Constipation? Diarrhea?) and that the doc took a couple of biopsies to have them checked for microcolitis. They presented me with some after care instructions and some lovely full color pictures of my intestines and colon. Jackpot! I think I'll have these framed! Or maybe I'll put them in a scrap book. I came home, ate some breakfast (NO, not Long John Silvers, silly) and laid down to watch TV. I guess the anesthesia hadn't completely worn off, as I fell asleep while trying to find something to watch (or at least that's what I'm told). I woke up about five hours later because no one was answering the stupid phone. If the phone hadn't rung, I might've slept all day and all night. Around 5pm, I started having gas, bloating and abdominal cramping (and something that might be what an ice pick in your gut feels like, where I presume they took the biopsies from). It got so bad, I had trouble walking, and even trouble sleeping through the night. Today I feel pretty decent. Minor bloating and cramping, but also some major D - a side effect of the MoviPrep (aspartame is NOT my friend - I'll probably be like this the rest of the week). So, it's time for more waiting. Still no stool sample results yet, and should have pathology report early next week. The cruddy thing about this? I never actually got margaritas.
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