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Celiac.com 09/14/2018 - Celiac.com was all set to do a story on the latest peer-reviewed data on the Nima gluten testing device, when along comes Gluten-Free Watchdog with another of their famous non-recommendations. Gluten-Free Watchdog says they cannot recommend the Nima gluten test kit because of alleged flaws. But what does the science say? The latest Nima article and Gluten-Free Watchdog’s complaint both focus on the science, so let’s start there. Nima makes two different food sensors: one detects gluten, the other detects peanuts. Each sensor comprises a small, handheld electronic device and a cartridge. To test food, consumers place a pea sized amount into the cartridge, place the cartridge inside the sensor, and run the device. They then receive a smiley face or wheat symbol with "gluten found," depending on whether or not the Nima device detected the allergen. Nima reported their original data in a peer-reviewed scientific journal. Among the conclusions: “Compared with reference R5, Nima antibodies (13F6 and 14G11) had 35- and 6.6-fold higher gliadin affinities, respectively. Nima demonstrated device performance using a comprehensive list of foods, assessing detection sensitivity, reproducibility, and cross-reactivity. Nima presented a 99.0% true positive rate, with a 95% confidence interval of 97.8%–100%.” Gluten Free Watchdog says that: “Based on third party testing data, the Nima Sensor fails to detect gluten at the 20 ppm level over 20 percent of the time. It isn’t until a sample contains a level of gluten at the 40 ppm level, that a gluten found result is received close to 100% of the time.” Gluten Free Watchdog suggests that this is a problem, because: “At a level of gluten in a sample from less than 2 ppm up to a level of gluten between 30 ppm and 40 ppm, the result displayed on the Nima Sensor may be either smiley face or gluten found. If a sample is tested with a Nima Sensor and the result is a smiley face, there is no practical way for a consumer to know if the level of gluten in the sample is less than or more than 20 ppm. If a sample is tested with a Nima Sensor and the result is gluten found, there is no practical way for a consumer to know if the level of gluten in the sample is less than or more than 20 ppm. As a result, the data point received from the Nima Sensor for gluten presents major interpretation problems.” Gluten Free Watchdog charges that Nima uses “NOT the scientifically validated Ridascreen Gliadin R5 ELISA Mendez Method from R-Biopharm used by Gluten Free Watchdog.” The fact is that R5 Elisa remains the industry standard for most testing applications. Gluten Free Watchdog closes its warning with a word from their independent expert: According to Adrian Rogers, Senior Research Scientist at Romer Labs, “It could be argued that the device is not fit for purpose as the company states that there is a clear differentiation between safe and unsafe products based on a 20 ppm level which the validation data does not corroborate.” It’s worth noting that for all his accomplishments, Rogers is neither a doctor, nor a PhD. Rogers' LinkdIn page lists his education as: Bsc (Hons), Microbiology, University of Wales, Aberystwyth. A Bachelor of Science degree may not necessarily make an expert in this subject, yet he is presented as one. Rogers also seems to have a potential conflict of interest that was omitted in Thompson’s press release. Directly from Rogers’ LinkdIn site: “Romer Labs®, Inc. developed an immunochromatographic lateral flow assay for the qualitative detection of gluten in raw ingredients, processed foods, finished food products, and environmental surfaces, using the G12 antibody developed by Belén Morón. The G12 antibody targets a 33-mer peptide which is resistant to enzymatic digestion and heat denaturation, as well as being the fragment of the gliadin protein to which celiac disease sufferers react, making it a reliable analytical marker.” The company Rogers works for, Romer Labs, makes its own gluten testing kits. It seems a bit disingenuous for Gluten Free Watchdog to use a spokesperson from a potentially competing company to try to counteract a peer-reviewed scientific publication for a device which is made by a potential competitor. Nima’s Scientific Advisory Board includes some of the most highly respected celiac disease researchers and scientists in the world. They include: Peter HR Green, MD Phyllis and Ivan Seidenberg Professor of Medicine. Director, Celiac Disease Center at Columbia University; Jody Puglisi, PhD Stanford University Professor of Structural Biology; Lucille Beseler, MS, RDN, LDN, CDE, FAND Family Nutrition Center of South Florida; Benjamin Lebwohl, MD, MS Director of Clinical Research Celiac Disease Center at Columbia University; John Garber, MD Gastroenterology, Mass General; and Thanai Pongdee, MD Consultant, Division of Allergic Diseases, Mayo Clinic. Nima says that Gluten Free Watchdog’s view of their recently published validation is incomplete and misleading. Nima wrote: “All the studies show Nima is highly sensitive across a range of both low and high levels of gluten." "The Nima third party data accurately reported gluten found at 20 ppm and above between 93.3% for food as prepared (a food item that is spiked with an intended quantity of gluten) and 97.2% for food as quantified by an ELISA lab kit (used to determine the exact ppm of gluten in the food)." "The Nima peer reviewed study published in the Food Chemistry Journal reported gluten found at 20 ppm and above at 96.9% accuracy." The statement that: “'Nima will fail to detect gluten at 20 ppm 20% of the time' is almost entirely driven by 1 specific food out of 13 tested. That sample, when quantified, was actually below 20 ppm." "In real life, people get glutened at many different ppm levels, not just 20 ppm. Nima has been shown to detect gluten at levels below, at and above 20 ppm across a variety of foods in a number of studies.” Reading the peer reviewed data provided by Nima, and reading Gluten Free Watchdog’s complaints, it becomes clear that Gluten Free Watchdog’s complaints sound serious and authoritative, but ring a bit hollow. Consider the Following Analogy Imagine a gluten-sniffing dog that performed as well as Nima in scientific trials; same performance, same exact data. You can give this dog a sniff, or a small bite of food, and he can signal you if the food’s got gluten in it with 97% accuracy at 20ppm or below. Nearly 100% accuracy at 40ppm or above (as stated by Gluten Free Watchdog). People would think that the dog was not only cute and fluffy, but wonderfully helpful and everyone would love it, and everyone with celiac disease would want one. And it would be a great big gushing warm and fuzzy feel-good story. Pretty much no one would be arguing that the dog was potentially dangerous, or somehow unfit for people with celiac disease. Such dogs would also be far more expensive to own and maintain than the Nima device. Apparently such dogs can cost upwards of $16,000, not including the cost of food, vet bills, etc. So, what’s the accuracy rate of a gluten-sniffing dog, anyway? From Mercola.com: Willow, a German shorthaired pointer, is another gluten-sniffing dog, in this case living in Michigan. Her owner, Dawn Scheu, says she can detect gluten with 95 percent to 98 percent accuracy. She worked with a trainer (the same one who trained Zeus) to teach her own dog to detect gluten, with excellent results. Gluten-sniffing dogs may detect gluten in amounts as small as .0025 parts per million with 95 percent to 98 percent accuracy. So, will Gluten Free Watchdog be warning against gluten-sniffing dogs anytime soon? Somehow, because Nima is a mechanical device made by a company, it's not so warm and fuzzy, not so feel-good. Maybe Nima needs to shape their device like a cute little doggy, or a Pez candy dispenser? But the data remains, as does the fact, whatever its drawbacks, anything that detects gluten like Nima does, as well as it does, is potentially very helpful for celiac disease in numerous situations. And it is extremely unlikely to do them any harm. Nima seems very much committed to transparency, scientific excellence, and continual product improvement. These are noble goals and generally a win for people with celiac disease. Think of it, just ten years ago, a portable gluten-sensor with the kind of accuracy Nima is reliably achieving would have been the stuff of fantasy. Yet here it is. More accurate than any gluten-sniffing dog, and for a couple hundred bucks. People with celiac disease are living in a very different world than just a few years ago. Nima did not have to publish its data, but it chose to do so, and in a reputable, peer-reviewed scientific journal. Nima conducted its research using solid scientific standards, and reported those results publicly. They explained their methodology and results, they acknowledged product limitations and expressed a commitment to improvement. How is this remotely controversial? The celiac disease community is fortunate to have companies committed to investing time and money into products and devices that help to improve the lives of people with celiac disease. We feel strongly that the perfect should not be the enemy of the good. Devices like the Nima gluten sensor can be helpful for numerous people with celiac disease. Disclosure: Nima is a paid advertiser on Celiac.com. Celiac.com's advertisers do not influence our editorial content. Read Nima’s full report on test data at: Food Chemistry.com Read Gluten Free Watchdog’s Statement on the Nima device at: Glutenfreewatchdog.org Read Nima’s Reply to Gluten Free Watchdog at: Nimasensor.com
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When to Use Home Test Kits for Celiac Disease?
Jefferson Adams posted an article in Diagnosis, Testing & Treatment
Celiac.com 04/01/2019 - Over the years, testing for celiac disease has become easier and more reliable. There are a number of home tests for celiac disease antibodies, and a number of reasons people might want to test for celiac disease at home. Those reasons include privacy, cost, and convenience. There are two kinds of tests for celiac disease, antibody tests and genetic tests. Let's start with antibody tests. Celiac Antibody Testing The main antibodies targeted by celiac disease blood testing are Tissue Transglutaminase Antibodies (tTG-IgA). The tTG-IgA test will be positive in about 98% of patients with celiac disease. The trick is that people need to be eating gluten for the test to work properly. That’s an issue for some people who have already given up gluten. Tissue transglutaminase antibody (tTG)-IgA in adults has a sensitivity greater than 90%, and a specificity of over 95%. Another antibody, endomysial antibody (EMA)-IgA, usually correlates with tTG. It is more costly and is identified manually, thus it is not the first line marker. Home testing for celiac disease antibodies offers convenience and privacy. These tests are a great way to see if you need to be clinically tested for celiac disease. Test for Celiac Antibodies at Home There are a number of home tests for celiac disease antibodies. These test kits are great for pre-diagnosis in advance of clinical testing. Home test kits offer several advantages. The Advantages of Home Celiac Antibody Tests Convenience—No worries about lab appointments and clinics. Home kits allow you to test in the privacy of your own home. Confidence—to increase your confidence when consulting with a doctor to request testing and diagnosis. Price—Often cheaper than clinical tests. Privacy—Results kept private and not shared with insurers. This could keep your insurance rates lower. Celiac Home Testing Companies Companies making home test kits for celiac disease include: Imaware™—The Imaware™ home collection kit, is sold online. The test has two main components, lancets to pierce the skin and a micro-container to collect a blood sample. Using the lancet, you draw three to four drops of blood from your finger and deposit them in the micro-container. Only a small sample is needed because the test measures the antibodies in whole blood. Once the blood is collected, you send it in a pre-paid bag to Microdrop’s CLIA-certified lab. After the sample gets to the lab, it’s processed within 48 hours, with testing done for four celiac disease biomarkers, tTG-IgA, tTG-Igg, DGP-IgA and DGP-IgG. Overall, Imaware™ reports sensitivity of 95 percent and specificity of 99 percent. That means the test will correctly spot people with celiac disease 95 times out of 100, and people without celiac disease 99 times out of 100. Let’s Get Checked—Let's Get Checked offers an at home celiac test to identify celiac disease antibodies with online results in 5 days. Biomarkers include Tissue Transglutaminase (tTG), and Endomysial Antibodies (EMA) Stool & Urine Testing Gluten Detective—Stool and urine testing is still in its infancy, and not considered mainstream. However, Gluten Detective claims to offer the only home test for gluten exposure. They also claim that stool testing can detect celiac disease before gut damage occurs, in many cases. Clinical Celiac Antibody Testing Many major laboratories, such as Quest Diagnostics, handle analysis of clinical celiac disease testing. In most cases, home test kits are processed by the same labs that process clinical tests. Confirm Positive Test Results Celiac.com recommends a follow-up visit to a primary care physician for clinical confirmation and an official diagnosis of celiac disease before embarking on a life-long gluten-free diet. Genetic Celiac Testing Genetic testing won’t tell you if you have celiac disease, but it will tell you whether you are at risk of developing celiac disease. HLA-DQ2 & HLA-DQ8 About 95% of celiacs carry HLA-DQ2; while about 25% carry HLA-DQ8. Both the DQ type, and number of copies a person carries influences risk, and the potential severity of celiac disease. Two copies of DQ2 carries more risk than one copy of DQ8, or only partial DQ2. However, the absence of genes DQ2 and/or DQ8 does not preclude gluten intolerance or sensitivity. Some people respond to a gluten free diet, even if they don't have DQ2 or DQ8 or clinical celiac disease. In some rare individuals, especially some men, a negative genetic test may not exclude the possibility of celiac disease anymore than a negative blood test. Celiac Genetic Testing Companies Celiac Disease DNA Test Invitae Further information on testing companies can be found at the Celiac.com Forum. More helpful information about celiac genetic testing can be found in the Celiac.com article Ten Facts About Celiac Disease Genetic Testing. Read more at The New York Times.- 1 comment
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Do You Have a Gluten-Free Emergency Food Kit?
Jefferson Adams posted an article in Additional Concerns
Celiac.com 11/24/2017 - Do you have an emergency survival kit at home should disaster strike? Does that include drinking water and gluten-free provisions for at least a few days? The fallout from the latest string of disasters still looms over parts of America; over Houston, Florida and neighboring states devastated by Hurricanes and by resulting floods; and over northern California communities devastated by wildfires. That got us thinking about emergency kits. Gluten-Free-free emergency kits, to be precise. What's in Your Emergency Gluten-Free Food Kit? This list is by no means authoritative or final. In fact, we are inviting you to share any favorites or ideas you may have for your own emergency kit. Your Gluten-free Emergency Kit should include the following: Water: You'll need a minimum of 3 days worth of drinking water for ever person. This includes water for cooking and other non-drinking uses. When it comes to water, it never hurts to have more than you need, so consider stocking even more than a 3 day supply. Food: When assembling a survival kit, you want to put together a kit that will feed each family member family 2 cups of prepared meals 3 times a day. Canned foods like black beans are essential. Any of the following food items are good to have in your kit: Rice, Quinoa and Other Gluten-free Grains: Organic grains like rice and quinoa make great additions to an emergency kit. Be sure to soak your grains before you cook them. If you're on a grain-free diet, quinoa works well, if you can tolerate it. Dried Potatoes: Dried potato flakes can be used to make mashed potatoes. Pasta: Gluten-free pasta are good additions to any emergency kit. Gluten-free Crackers or other snacks: Gluten-free crackers can be part of a no-cook meal, especially when combined with canned tuna or other fish. Canned Pasta Sauces: If you're stocking gluten-free pasta, then be sure to stock your favorite pasta sauce. Pomí makes a boxed pasta sauce that packs easily for emergency storage. There are a number of canned pasta sauces on the market, so stock whatever you like. Canned and Dried Meats: Jerky, Spam, Dried Salami, and Canned Tuna or other Fish make excellent additions to any emergency kit. Homemade jerky can be kept in an air-tight container for about a year. It's a great source of protein, and a great no-cook snack with options like beef, bison, pork, turkey and salmon. Spices and Gluten-free Bouillon cubes or packets: Since you may be making things like rice, or quinoa, or other things that may need some spices to lively them up, spices are a smart addition to your emergency kit. Make sure yours are gluten-free. Keep your kit in a cool, dry place that can be reached in an emergency. Consider building your kit around a printed menu that can be prepared with the items you have stocked. Remember, since gas and electric may not be functioning in an emergency, you may not have full cooking facilities, so plan meals that you can make with minimal preparation and fuss. Want someone to make your emergency kit for you? Check out https://www.emergencykits.com/emergency-food/gluten-free. -
Celiac.com 11/11/2017 - (NOTE: This article is from 2012 and is being made available as Celiac.com rolls our past issues of Journal of Gluten Sensitivity) It's just like being a little kid with a super sore throat and your mom taking you to the doctor to get a test for strep throat. The doctor swabs your throat with two sticks to find out what nasty bacteria is camping out. In just moments you've got a diagnosis of strep throat and can start antibiotics to miraculously make the pain go away. You go home with a prescription, get in bed and eat mom's homemade chicken rice soup until you feel better in a couple of days. How cool would it be if getting diagnosed with celiac disease was this easy? The wonderful news is that we're getting closer to having a test that will diagnose celiac disease with just a simple prick of a finger and a 10-minute wait. The CeliacSure Test Kit measures (anti-tTG) IGA antibodies from a fingertip blood sample. It works by taking a small drop of blood, mixing it with a buffer and applying the mixture onto a test cartridge. Within moments two red lines appear if the test is positive, while only one line appears if the result is negative. And, you can take the test at home without ever getting out of your pajamas! "The test kit is a point-of-care, at-home test that's very similar to reading results of a pregnancy test," said Dr. Daniel Leffler of the Celiac Disease Center at Beth Israel Deaconess Medical Center in Boston. Dr. Leffler, a gastroenterologist by training with a background in nutrition, has a long-standing interest in celiac disease. Several years ago he teamed up with Dr. Ciaran Kelly and Dietitian Melinda Dennis to found the Celiac Disease Center at Beth Israel Deaconess Medical Center where they focus not only on providing top notch patient care, but also on high level disease research. The latest project: studying the efficacy of the CeliacSure test for celiac disease diagnosis. Dr. Leffler said his team got involved with the finger prick test study because they feel it's important to take down barriers to patients getting diagnosed with celiac disease. "We do a lot with educating other medical providers about offering in-clinic testing, but I think it's really important to put a tool in the hands of the people." "We've teamed up with the [marketers] of the test kit at GlutenPro/Biocard CeliacSure Test to see how effective this test is in the USA. We're providing 2 kits per family to use on first-degree relatives of people with celiac disease. To qualify, participants in the study must not be on a gluten-free diet. We send them the test kit to take as well as a survey about their ability to use and understand the test. The goal is that this small study comes out favorable [sic] so we can move on to large scale studies that will compare the finger prick test to the gold standard laboratory serology testing." Dr. Leffler says he's really excited about the potential of this point-of-care test because it will "allow us to reach a population that might not otherwise come in to get tested, mainly first degree relatives of patients already diagnosed with celiac disease." It's important to note that right now the CeliacSure test is only for research purposes, not actual diagnosis. It is available in Canada and other countries, but it's still under evaluation here in the United States. And, while the strep throat analogy is a great way to think about how this test will work, it's extremely important to understand that if you get a positive result with the CeliacSure test, do not start a gluten-free diet until you have followed up with a doctor to confirm the diagnosis. As with all medical studies there's some fine print you need to know about. Participants in the study must meet all of the following criteria: 1. Over the age of 18 2. A first or second degree relative with celiac disease 3. Not previously diagnosed with celiac disease 4. Not on a gluten-free diet or low-gluten diet within the past 3 months 5. Able and willing to self administer the test, complete a short survey form and return both in the envelope provided 6. Willingness to have follow up medical evaluation in the event of a positive test 7. A resident of the United States Listen to a full interview with Dr. Leffler about the CeliacSure study on the Hold the Gluten Podcast (http://traffic.libsyn.com/holdthegluten/050_HoldTheGluten-05Apr2012.mp3) with Vanessa Maltin Weisbrod and Maureen Stanley now! And, if you would like to participate in the study, please contact Dr. Toufic Kabbani at celiac@bidmc.harvard.edu or by phone at 617-667-0528.
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