Gluten Free Watchdog’s Updated Position Statement on the Nima Sensor for Gluten

Gluten Free Watchdog’s Updated Position Statement on the Nima Sensor for Gluten

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.

 

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Comments (21)

  • Carol Steehler
    Reply

    Thank you for all the time and effort you put into researching this gadget.
    I’ve never trusted claims made about it.

    September 6, 2018 at 1:41 pm
  • Jamie Reply

    Thank you Tricia for all of your hard work!

    September 6, 2018 at 1:51 pm
  • Michelle Brazeau Reply

    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.

    September 6, 2018 at 3:29 pm
  • Thora Toft Reply

    Thank you for making the effort for those of us who want to be 100% certain! Me and my tribe truly appreciate it!

    September 6, 2018 at 5:18 pm
  • Sue Clark Reply

    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…

    September 6, 2018 at 10:04 pm
  • Danielle Reply

    Tricia, you rock. The celiac community is a better place with you as a member. Thank you for your persistence to ensure our health!

    September 7, 2018 at 1:14 am
  • Stella Reply

    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!

    September 7, 2018 at 11:16 am
    • Kiran Reply

      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.

      September 8, 2018 at 6:17 am
      • Rebecca Reply

        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.

        December 2, 2019 at 2:41 pm
  • Garrett Reilly Reply

    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!

    June 13, 2019 at 5:45 pm
  • Jack Reply

    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.

    January 18, 2020 at 11:32 pm
    • Tricia Thompson Reply

      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.

      January 20, 2020 at 12:00 am
  • Daniel J Harkavy Reply

    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?

    June 29, 2020 at 8:54 pm
    • Tricia Thompson Reply

      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.

      July 8, 2020 at 12:25 pm
      • Miriam Reply

        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.

        July 30, 2020 at 4:42 am
        • Tricia Thompson Reply

          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.

          August 2, 2020 at 5:44 pm
  • Celiac3242 Reply

    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.

    August 4, 2020 at 2:06 am
  • Julie Reply

    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.

    September 15, 2020 at 6:18 pm
    • Tricia Thompson Reply

      Hi Julie, Nima Labs has been acquired by Medline Industries. From what I understand, they do not have capsules available at this time.

      September 22, 2020 at 10:12 pm

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