Gluten Free Watchdog’s Updated Position Statement on the Nima Sensor for Gluten
Please also see:
Tricia Thompson, Adrian Rogers, Johnna Perry. Consumer-Led Investigation into Potential Issues That Arise When Testing Dairy Matrixes for Gluten With the NIMA Sensor. Journal of AOAC INTERNATIONAL, 2023; qsad092 https://doi.org/10.1093/jaoacint/qsad092
At Gluten Free Watchdog we are not able to recommend the Nima Sensor consumer testing gadget* for gluten. Third party testing data released yesterday by Nima Labs has further solidified our position. This testing data confirmed what we’ve noted in our own testing with this gadget. There is no way to know whether a smiley face test result from the Nima Sensor is a true negative in terms of the gluten-free labeling rule (gluten below 20 ppm) or a false negative (gluten at or above 20 ppm). And there is no way to know the level of gluten in a sample that resulted in a gluten found result.
Note: According to Nima Lab’s website a smiley face means either no gluten detected or gluten detected below 20 ppm. Gluten found according to Nima Lab’s website means gluten was detected at any level in the sample. Also according to Nima Lab’s website, “Nima is not a quantitative test but has been tuned to detect with a high level of accuracy at 20 ppm and above.”
False negatives. 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
(See the screenshot of the table posted below and presented in the Nima and FARRP webinar on the FARRP evaluation of the Nima Sensor available at https://www.youtube.com/watch?v=pI7VFQpxpNQ&feature=youtu.be)
Gluten Found: Nima Labs has previously stated that when a sample contains a level of gluten below 2 ppm, the Nima Sensor is reporting gluten found approximately 8% of the time. Based on third party testing data this gadget is reporting gluten found approximately 35% of the time when the level of gluten is 5 ppm and approximately 56% of the time when the level of gluten is 10 ppm (Note: from a practical standpoint this means that if a sample contains a gluten level of 10 ppm there is about a 50:50 chance of getting either a smiley face result OR a gluten found result).
Why is this a problem? 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.
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.”
*The Nima Sensor for gluten does not appear to meet current FDA requirements for medical device designation. Therefore it is referred to here as a “gadget” to prevent confusion.
Screenshot of the table presented in the Nima and FARRP webinar on the FARRP evaluation of the Nima Sensor available at https://www.youtube.com/watch?v=pI7VFQpxpNQ&feature=youtu.be
The R5 ELISA used in the FARRP evaluation and named in the table is from Neogen. It is NOT the scientifically validated Ridascreen Gliadin R5 ELISA Mendez Method from R-Biopharm used by Gluten Free Watchdog.
Comments (38)
Thank you for all the time and effort you put into researching this gadget.
I’ve never trusted claims made about it.
Thank you Tricia for all of your hard work!
Thank you for doing this. I’ve posted it on all my platforms, and I’m hoping my followers will spread the info far and wide.
Thank you for making the effort for those of us who want to be 100% certain! Me and my tribe truly appreciate it!
I have always wondered how an individual could get an accurate test from one small capsule from one part of the food to be tested.
My latest insight came when I thought, “what if you tested your BM? That would give you (up to three days) homogenized sample.” True, it will be after the fact of exposure…
Tricia, you rock. The celiac community is a better place with you as a member. Thank you for your persistence to ensure our health!
Thanks for this!! I wanted one and actually believed it would help me figure out what’s safe for me to eat at home as a highly sensitive Celiac.
I can’t even put spices in my food because I have no idea what’s keeping me sick.
Much appreciated!
Being celiac comes with just more than gluten/wheat allergies. I also cannot have – dairy, soy, nuts (including coconut), fats (oils like olive and canola are a no go), oats and most grains. I can have rice. I boil all my foods. You may have something else along with celiac like crohns or UL. I am being tested for those as I am sick all the time and have cut away so many foods I need to see a nutritionist.
Yup. Me too. Gluten makes me vomit 2 hours after eating so I know if I’ve gotten poisoned. But I also have milder reactions to most foods so it’s hard to say what else I’m not tolerating. I’ve cut out histamines and citrus and legumes. Oddly eggs dairy and nuts don’t bother me. But everything else does. Oats are almost as bad as gluten. Even GF oats. Why do some gf products contain oats? I don’t know anyone with celiac who can eat gf oats.
I was diagnosed with celiac early this year and have been having gluten-free oatmeal every morning with no issues. Maybe I’m not that sensitive. My celiac was found because of malabsorption issues rather than from typical symptoms.
So, I have read articles on this website and read the Nima response to these concerns and it is clear that Nima is spinning the research for marketing purposes. I guess my question is this, even though the Nima gadjet isn’t as accurate as Nima claims, isn’t it still better than not using anything at all? False positives just mean that I am throwing food away that is safe for me, expensive but I can live with it. False negatives are more concerning but once again isn’t it better to catch some of the gluten than to fly blind and simply guess. Any insight would be greatly appreciated!
Please read the article, THE POTENTIALLY PERILOUS PROMISE OF FOOD ALLERGEN SENSORS available at https://www.theverge.com/2019/4/1/18080666/nima-sensor-testing-fda-food-allergy-gluten-peanut-transparency-data
I can eat gf oats and I was diagnosed a year ago. The first 6 months no but the Dr told me to keep trying every couple months. It worked and I enjoy it every morning with milk.
This is an amazing device that has saved me from getting sick so many times. It’s always been accurate when I’ve used it and if I get a positive I check it twice just to make sure. I’m glad that it tests below 20 ppm because I get sick below 20 ppm. It has stopped me from getting sick in all the restaurants that falsely label food as gluten-free that’s not. And even when I’ve forgotten to use it and eat something that makes me sick it confirmed the leftovers had gluten in them. And when I use it and get a smiley-face I never get sick. It’s a shame that you’re putting down this device that has made gluten a non-issue for me these days. I really think you worry more about subscriptions than about helping the gluten-free community. You are doing a serious diservice to people by being so negative about this device.
Hi Jack, If you “really think” I worry more about subscriptions than about helping the gluten-free community then you know very little about me or the work we do at Gluten Free Watchdog.
I see that it’s not perfect, but it has saved my wife from “gluten free” restaurant dishes that were cross contaminated so many times that I have lost count.
Is there a better method to test for gluten on-the-go available?
Again: 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.
I often find myself confused by the assertion that because there might be false results, it is better to not use this device at all. I will preface this by saying that my daughter has been using the Nima sensor for a few years now, and it has saved her from getting sick numerous times when dining out.
Here is the part of the argument I don’t understand. Assuming that people aren’t using the Nima sensor in lieu of good decision making, and they continue to do the same things they would do when dining out that they would do if they had no Nima sensor (ie. research the offerings and practices at the restaurant, ask a multitude of questions to ascertain whether the restaurant is capable of and likely to make the dish safely, consult reviews of other diners experiences, etc), we are presented with a few possible scenarios:
1. The dish had over 20ppm and the Nima caught it. Great news – my daughter has just avoided weeks of suffering.
2. The dish had over 20ppm and the Nima didn’t catch it. That is very unfortunate, however we only test things that we assume would be safe based on the factors above, so without the sensor she would have assumed it was safe and eaten it anyway. Having the sensor has not caused a bad situation, just failed to prevent one.
3. The dish had less than 20ppm and it tested safe. Great news – an additional data point to suggest the food is likely safe, knowing that the sample doesn’t not represent the whole dish, which is why she still uses good judgement when deciding whether to order in the first place.
4. The dish had less than 20ppm and it tasted unsafe. I understand that some people don’t want to reject a food that is potentially safe, but given that 20ppm is not a magical number our family has decided that we would rather be safe than sorry. Our position is that we are ok rejecting something at any detectable level of gluten. Yours may not be.
When looking at these 4 possible scenarios I find it hard to figure out why the potential upside does not outweigh the potential downside.
The biggest detractors I have encountered say that someone might rely on the results and eat a food that has more than 20ppm of gluten. For this argument one has to assume that the person is using the sensor without doing all of the detective work that is expected of people who live with Celiac disease, because otherwise the person would have been eating the food anyway.
The times that we have been the most thankful for the sensor have been when simple human error in a restaurant, either from a lack of training or understanding on the part of a single employee or from just a careless mistake, led to my daughter being served food that would have made her very sick. And the few times she had been glutened prior to getting the sensor might have been prevented, as again they were do to human error despite her doing everything she was taught to do.
Hi Miriam, Thanks for your comments. There are 23 posts about the Nima gadget on Gluten Free Watchdog. You may find a more recent post useful https://www.glutenfreewatchdog.org/news/morning-musings-about-testing-food-for-gluten-the-nima-sensor/. One of the issues is that there is no way of knowing if a gluten found result means the pea size portion tested contains a level of gluten below or above 20 ppm. There is also no way of knowing whether a smiley face means the pea size amount tested contains a level of gluten below or above 20 ppm. As stated in the post, if the pea size portion contains a level of gluten of 10 ppm, it will show a smiley face 50% of the time and a gluten found result 50% of the time. From my perspective, this makes the gadget useless.
You wouldn’t consider it useful to know if your food has above 40ppm and a 50% chance of knowing it has below 40ppm? For me, having a virtual guarantee that it has above 40ppm is a life saver on its own. I have been using Nima for years and it has saved me from epilepsy numerous times (gluten triggers it).
As is written in the post: Why is this a problem? 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.
This is not my point. My point is that in many cases, the food will actually have more than 40ppm gluten. This is really useful. For example, a waiter claims your bread is gluten free, or your pasta is gluten free. We’re not talking about minor cross contamination issues. When the food is between 20-40 ppm, the result may be 50/50. Already having a virtual guarantee of detecting gluten above 40ppm is *huge* for me and many others. If a seatbelt saves lives 90% of the time, would you tell people it’s useless because in 10% if the cases it does not?
The problem is that a user has no idea how much gluten is in the actual product (and please click on the table as the data you are providing is not accurate). The Nima can give a gluten found result anywhere from less than 2 ppm on up. If you get a gluten found result a user has no idea whether the pea size portion tested contains < 2 ppm or 100 ppm (or more). If a user gets a smiley face, there is no way to know if the product actually contains less than 20 ppm gluten (20% of the time, gluten will not be detected--more often for some foods, less often for others). In addition,the user is testing a pea size amount. This is not how validated testing works. Gluten is not evenly dispersed in a product and samples must be homogenized before testing. We've published numerous posts on the Nima. Please see https://www.glutenfreewatchdog.org/news/gluten-free-watchdogs-updated-position-statement-on-the-nima-sensor-for-gluten/. Please also see the excellent article in The Verge https://www.theverge.com/2019/4/1/18080666/nima-sensor-testing-fda-food-allergy-gluten-peanut-transparency-data.
I will quote from the site you mentioned: “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.”.
So you have a 20% chance of Nima not detecting gluten when it’s between 20-40ppm. Above 40ppm, it detects gluten virtually 100% of the time. I’m not sure how this could not be useful for you in your daily life? I don’t need Nima to tell me the *exact* amount of gluten. I need Nima to tell me if it has gluten above a certain level that affects me. Having an almost 100% guarantee that the food that was tested has gluten above 40ppm is a huge deal for me, and having 80% guarantee in cases where it is between 20-40ppm is also huge. I don’t really understand why you cannot see that? The FDA requires <20ppm to be labeled gluten free. Having 80% chance of accurate detection is a big deal. And in many many cases, it has well above 40ppm, especially in restaurants. And in regards to pea size samples not being accurate: In most cases, a pea size sample is sufficient. Unless you’re testing something like oatmeal where you’d need to eat the whole pack to get above 20ppm. But from my personal experience, it detects gluten in crosscontaminated frying fat and many other crosscontamination situations. It saved my life numerous numerous times in restaurants. In fact, I would not be able to eat out without it. I would still genuinly like to understand why guaranteed above 40ppm and 80% 20-40ppm detection would not be useful to you.
But that isn’t what the Nima is telling you. A gluten found result means that the pea size amount might contain a level of gluten anywhere from less than 2 (not 20) ppm on up. A user has no way of knowing the amount of gluten in the product. And you are not correct in your assessment that a pea size amount is an accurate assessment of the gluten level in an entire meal/product in most cases. This is a major issue in the food testing community–how to accurately assess gluten levels in heterogeneous samples. If you are happy with the Nima, then by all means use it. Why is it not useful to me? Because I fully understand just how difficult it is to accurately test for gluten. If you are truly interested in learning about testing, there is plenty of information on this site to help you understand. Olivier, I have to move on from this discussion, but again, please read the posts on the Nima to fully understand the concern. I posted the wrong link earlier. Here is the link to all articles on the Nima https://www.glutenfreewatchdog.org/news/category/nima-sensor/
If it would have 2ppm I would not eat it either, so I’m ok in the rare cases it would detect minor trace amounts. Any gluten is bad for me. I’d rather have it alert me for trace amounts versus not alert me. And when I cook gluten free, Nima confirms it’s gluten free, so it’s not like it gives me false positives the whole time. Thanks for the discussion. And next time you go to a restaurant and the waiter told you the spaghetti or bread is gluten free or the fries are “safe” and you find yourself suffering the day after, remember that Nima would have been able to tell you 😉
This is a great device. You are completely wrong to not recommend it. It has always been accurate for me, you are discouraging people from buying something that will help them tremendously.
Based on third party testing data, if a product has a gluten level of 10 ppm, approximately 50% of the time the sensor will read “gluten found” and approximately 50% of the time the sensor will show a smiley face. This is exceedingly problematic. Please also see a more recent post at https://www.glutenfreewatchdog.org/news/morning-musings-about-testing-food-for-gluten-the-nima-sensor/
Tricia, I’ll concur the above comment (but I do appreciate your work). However, you must realize that the average celiac consumer has no recourse whatsoever for testing. This device at least gives me much a clearer picture. Can it be wrong under 20 parts per million? Yes, and of course that’s no ideal. Point me at a better test that I can use anywhere and get more accurate results and I’ll use that. But, as you know, there’s nothing of the like available to your average person.
Hello Tricia,
Thank you for sharing information and comments posted on the nima sensor. I understand your group has completed a great amount of research so I will not argue scientific data, but will concur with some of the comments based on personal experience. I found that this sensor has indeed saved me from consuming food with gluten when eating out, especially after the restaurant staff had assured me that the meal was gluten free. Of course a sensor that was 100% accurate would be an ideal tool for me and all celiac patients, but for now I think that anything that one finds helpful is appreciated.
Unfortunately, the nima capsules have become unavailable. I came across your site while searching for nima capsules in hopes of finding information here. I contacted the company and received this reply:
“General Support
Aug 27, 2020, 10:05 AM
to me
Nima was acquired by a medical supply company in 2020 and can no longer guarantee that this communication channel will be monitored. Moving forward, please direct questions to Amazon or the distributor that is currently distributing Nima products on Amazon.”
Amazon does not have the capsules either. Can you, or anyone following along supply any updated information? I am hoping to find the capsules, and am open to any new sensors or products as well. Thank you.
Hi Julie, Nima Labs has been acquired by Medline Industries. From what I understand, they do not have capsules available at this time.
This article strikes me as missing the forest for the trees. If you told me I could detect over 40 ppm with any probably greater than a coin flip, I’d take it. Over many samples, this will lead to me getting glutened fewer times than I otherwise would. In reality, the data is WAY better than a coin flip. Why not educate your audience about the limitations of the device, instead of dismissing it outright? While everything you’ve said is accurate, your conclusion to outright reject the device is misguided.
Hi Matthew. We’ve written 23 articles on the Nima. In other words, we did not outright dismiss this gadget but spent a lot of time and money evaluating it. We also spent a lot of time on the phone with the developers of the Nima before and after it went to market. See https://www.glutenfreewatchdog.org/news/category/nima-sensor/.
Thanks Tricia, I appreciate your response. And as a subscriber to Gluten Free Watchdog I thank you for everything you’ve done to make me eat more confidently without getting sick.
I think where I’m hung up is on the probability of getting a reading between 5 and 40 ppm. If you tested food at 100 restaurants, how often do you think it would come in between 5 and 40 ppm? My prior assumption (partly informed by how often Gluten Free Watchdog finds) that happening is it will be rare occurrence. Rather, most reading will come in way higher or lower. For example, in the case of a server mistakenly giving you whole wheat toast, you’d get a reading way higher than 40 ppm. So to me, all else being equal, I think I’d have a much lower probability of getting glutened if I used the sensor. What’s your instinct on this? Do you think readings between 5 and 40 ppm are common? I grant you that if that’s the case, then I agree with you.
There is a lot to unpack here and I must admit that I am weary of discussing the Nima BUT… Keep in mind that you are not only trying to compare packaged food products to restaurant meals but laboratory testing that involves homogenizing (evenly distributing) gluten to consumer testing that typically doesn’t involve homogenizing a sample.
How often restaurant food might test in the 5 to 40 ppm range depends on the restaurant but the working assumption is that cross contact within a restaurant setting (especially a busy restaurant) is not risk-free. This is not to say that folks with celiac disease must eat in dedicated gluten-free restaurants BUT they do need to make sure the restaurant is taking precautions to prevent cross contact.
If what you are trying to prevent is accidentally consuming a wheat-based product such as bread or noodles (and you are willing to eat wheat crumbs from cross contact), then yes, a lateral flow test should catch this (and this is the reason why other lateral flow tests have high gluten and very high gluten readings—for whatever reason, the Nima team did away with this reading). BUT if you are also trying to prevent eating food that contains wheat crumbs due to cross contact, testing a single pea-size sample of a product may miss this cross contact depending upon the distribution of cross contact (cross contact by nature tends to be unevenly distributed). Please see the video I posted at https://www.glutenfreewatchdog.org/news/using-nima-to-test-for-spotty-cross-contact-with-gluten/
As I wrote in one of my last posts on the Nima (see https://www.glutenfreewatchdog.org/news/morning-musings-about-testing-food-for-gluten-the-nima-sensor/), The bottom line for me: If I test a pea-size amount of food from a non-homogenized sample and the result is a smile what does this tell me? Based on the FARRP study and the table presented during a FARRP webinar about the study (table posted at https://www.glutenfreewatchdog.org/news/gluten-free-watchdogs-updated-position-statement-on-the-nima-sensor-for-gluten/) it tells me that the pea size amount tested may contain from below 5 parts per million gluten up to 40 parts per million of gluten. It does not tell me anything about the rest of the food on my plate.
If the result is gluten found what does this tell me? Again, based on the data from the FARRP study (as well as data previously provided by Nima) it tells me that the pea size amount tested may contain from below 5 parts per million of gluten on up.
Look at the overlap. Both results—smile and gluten found include values from < 5 ppm up to 40 ppm (and even higher for some mixtures). Maybe if the Nima team can improve upon this overlap, this gadget may have some of the uses that I was originally hopeful it would have—testing for gluten in foods when gluten is likely to be evenly distributed. Hope this helps a bit.
Thanks for outlining your thinking. I’m sure you are very busy and I appreciate you sharing all this. I’m a happy Nima user in certain scenarios at restaurants I already have some level of trust in. Thank you for helping me to contextualize results of the sensor and for interpreting results with context. As you state, it’s not a perfect device for all cases. Your writing on this topic has deepened my understanding of when and when not to use this tool. Thanks for that, and again, big thank you for everything you do at Gluten Free Watchdog. Cheers!
Is there a better alternative to Nima gadget?
There are other consumer tests but they are also lateral flow devices–EZ Gluten and Gluten Tox Home. Please see https://www.glutenfreewatchdog.org/news/lateral-flow-devices-nima-gluten-tox-home-ez-gluten-to-test-food-for-gluten-manufacturer-consumer-use/