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    Nima Labs Claps Back at Gluten Free Watchdog Over Gluten Sensor Data


    Jefferson Adams
    • Gluten-Free Watchdog says they cannot recommend Nima's portable gluten test kit because of alleged flaws. But what does the science say?

    Nima Labs Claps Back at Gluten Free Watchdog Over Gluten Sensor Data
    Image Caption: Image: Nima Labs

    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. 

    4 4


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    Guest Anne Ryan

    Posted

    The personal attack on Adrian Rodgers was unnecessary and detracted from your article.

    The Nima device targets the general consumer as a user, yet you claim that Adrian, with an honours degree in science, and 15 years postgraduate experience in developing food allergen/gluten immunoassays is not qualified to interpret the results, because he does not have a PhD.

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    Since he is being presented as an expert by Gluten-Free Watchdog, it is fair for anyone to question his credentials. I think the bigger point in this article is whether or not Gluten-Free Watchdog should have disclosed that Mr. Rogers works for a potential competitor of Nima's, thus making his assessment of Nima's voluntarily published data a potentially biased one. 

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    Guest Cynthia

    Posted

    Uh, yikes. I know that disclaimer at the end of the article says that the advertisers don't influence editorial content, but this sounds like an advertisement for the paid advertiser on top of being unprofessional. Not a good look, folks.

    Also, while the disclaimer that he works for Romer Labs is valid, a recent editorial by Yeung and Robert (2018) noted that the Nima sensor is an issue given that "[it's uncertain] whether data generated by Nima are comparable with AOAC Official Methods because there are no validation studies published in scientific literature" (Yeung & Robert, 2018, p. 75). We cannot just trust a company to have the best interests of the public in mind; that's why we have these reviews and additional studies.

     

    Referenced article:

    Yeung, J., and Robert, M. (2018). Challenges and path forward on mandatory allergen labeling and voluntary precautionary allergen labeling for a global company. Journal of AOAC International, 101(1), 70-76.

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    Guest Aims

    Posted

    Either way - I think Adrian has a valid point. Being one of the extremely sensitive Celiacs I'd be concerned about the amount of gluten detected. Not being able to know just how much gluten is in an item is a huge necessity for me.

     

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    The device is extremely accurate at reading the gluten content at 20 ppm and above, and is 100% accurate at 40ppm and above, but as their published results indicate, it isn’t perfect. For celiacs who want or need to eat outside their homes this tool does offer them a way to do this more safely than not having the device. 

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    Guest Melinda

    Posted

    Does Jefferson want to be the pot or the kettle? One of his main issues is that Adrian is a, "spokesperson from a potentially competing company." Yet Jefferson is a contributor to Celiac.com, for which Nima is a paid sponsor. I fail to recognize how either situation is different.

    Adrian's review of the 3rd party testing is helpful in providing feedback and critical insight of a food allergen detecting device. Especially since he is a research scientist in food allergen testing. It should also be noted that he did not conclude that the device development should be abandoned. He merely pointed out that improvements can be made going forward. 

    As consumers, we should be concerned why celiac.com responded with such outrage against a common outcome of a peer review process. Do they just want to push their sponsors' items or do they actually care about our health?

     

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    Guest Katie M

    Posted

    The study in Food Chemistry of the Nima was performed by Nima, not a 3rd party representative. Per the study, conflicts of interest include: "All authors, except for and Jonathan Ward and Dr. Alim Seit-Nebi are employees of Nima. Jonathan Ward was a former employee at Nima. Dr. Seit-Nebi is an employee at GenWay Biotech, Inc. and managed the contract research for this project, producing the 14G11 and 13F6 antibodies."

    Nima is also a paid advertiser on Celiac.com. Part of the published study reads like an infomercial for Nima. " We developed a novel solution, NimaTM, a gluten sensor that integrates food processing, gluten detection, result interpretation and data transmission in a portable device, detecting gluten proteins at or below the accepted 20 ppm threshold." Most credible scientific studies are written in 3rd person and do not describe the object being studied as "novel" in the abstract.   

    The above article states: "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." However, Nima is not a charity designed to help people with Celiac disease. It is a company that is profiting off of people with a disease who would like to improve their lifestyle and eat safe foods. Being as close to "perfect" as possible is necessary for their clients and "good" just isn't good enough. I appreciate Nima's and other companies' efforts to research and try to develop products for our community, but I want to ensure these products are safe before relying on them. I personally do not use the Nima because of my concerns about sample inhomogeneity. At least gluten sniffing dogs would smell a whole plate of food, while the Nima tests small amounts of the meal. Our community deserves to be fully educated about the Nima and dissenting views from Gluten Free Watchdog and others are important for us as consumers to make our own decisions about what we want to purchase. If the Nima is studied in the future by a reputable 3rd party in a scientifically sound study, I will revisit my stance on the Nima at that time. 

    It's important to note that the study's conclusion never once mentions Celiac disease by name. It states: "Based on our testing, the device showed many of the properties needed to help gluten-sensitive individuals navigate better a gluten-free lifestyle." Celiac.com should be well aware of the differences between gluten-sensitive and celiac disease and the omission of the words Celiac disease from the entire conclusion of this scientic study speaks volumes.

    Lastly, this article comes across as rude and condescending in tone. Let's all be on the same team when it comes to improving the lives of people with gluten-sensitivity and Celiac disease. It's okay to have different viewpoints and we grow as a scientific community when healthy debate takes place. This article appeared to come from a place of anger, and it is difficult to grow as a community when angry  rhetoric replaces healthy conversation.

     

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    We disclose all of our sponsors, as we've done in this article. It is fair for you to question whether or not our sponsors might influence our editorial content. We feel it is also important for others to mention possible conflicts of interest when presenting positions, which, in this case, did not happen. On Thursday we published this non-flattering article on Bob's Red Mill and how a group is suing them because small amounts of Roundup have allegedly been found in their oats. Bob's Red Mill has also been a sponsor of Celiac.com, and we hope they will be in the future, even after we published this. We felt that it was important to report this news to the celiac community, and that Celiac.com was the platform to do so. We are not sure how presenting a differing viewpoint here on the Nima sensor could mean that "celiac.com responded with such outrage." 

    As for Nima's original publication, they disclose all conflicts, and did not have to publish their findings. 

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    Guest Erin L

    Posted

    As a long time reader and person with celiac disease, I am disappointed in the professionalism of this article. Back in the day, we dreamed of having a better way to ensure our food was safe. Unfortunately, the Nima is not the key. The Nima is expensive and has aggressive marketing strategies which are demonstrated here as this author vilifies a long-standing member of our community. How much did you make on this post? I hope it’s enough to account for the loss of subscribers as a result of it. 

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    I don't understand your need to criticize gluten-free Watchdog for saying they can't recommend Nima. If I was asked, I couldn't recommend it either. Why is it necessary for another party to agree with your assessment? It's a difference of opinion. So what? This appears petty and malicious. 

    gluten-free Watchdog has done more to protect my health by alerting me to potential dangerous gluten-free products and now a testing device, than Celiac.com ever has, in my nine years of being a diagnosed Celiac. 

    I'm disabled from the neurological manifestations of celiac disease. If I get any amount of gluten, I'm sick (bed-bound) for a minimum of six weeks. Nima is not a useful tool for me. Too risky. 

    But let's put that aside. Why the mean spirited attack on gluten-free Watchdog? What do you hope to gain? What I see is GFWD wants what's in my best interest. Don't you want the same? 

    Sincerely,
    Julie

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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 Dangerous Grains by James Braly, MD and Ron Hoggan, MA.

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    Elias was trained in Slovenia over the course of many weeks for his gluten detection training. Now he has the capability of detecting gluten in all sorts of hot and cold foods.  According to USA Today, “Teaching a dog to be alert to the scent of gluten is much more complicated than most scent-detection training, because gluten comes in so many forms.” Gluten can appear in bread and cereal products and can be processed in many different ways. It can also appear in less obvious products as binders or thickeners, in foods such as salad dressing and even in products such as Play-doh and lipstick.
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    With an increase in research and awareness, we have not only witnessed an increase in celiac disease diagnosis, but also several advancements, for instance the availability of products such as home gluten testing kits, home celiac testing kits, and gluten-digesting enzyme formulas, which have all contributed toward making gluten-free living less of a challenge. Gluten-detecting dog training is yet another advancement, which I hope will have a positive impact on the lives of severe celiac cases such as Hollie Scott.  
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    ELISA Technologies: EZ Gluten® http://www.elisa-tek.com/ez%20gluten.htm Gluten Free Society: Gluten Detecting Dogs http://www.glutenfreesociety.org/gluten-free-society-blog/gluten-detecting-dogs/ Two Little Cavaliers: Gluten Detection Dog  http://blogs.dogtime.com/two-little-cavaliers/2011/01/gluten-detection-dog USA Today: Pet Talk: Show dog knows his business, and his gluten http://www.usatoday.com/yourlife/pets/dogs/2011-01-11-pettalk11_ST_N.htm 

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    The test was very simple to run: I took a pea-sized sample of the beans and put them in the one-time-use capsule, inserted the capsule into the sensor, pressed start and waited about 3 minutes. The sensor made some noises while running, and then I saw a smiley face appear, which meant that my beans were safe and below 20 ppm (if the wheat icon shows up it isn't safe).
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