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.