Nima validation data

Nima Chemistry vs. R-Biopharm

Date: January 5, 2018

Nima conducted a study of Nima chemistry compared to R-Biopharm’s R7001 kit. The R-Biopharm kit uses the leading gluten detection antibody. Nima tested 47 different items, with a sample going to multiple labs for comparison. Nima identified all cases where gluten was present at more than 20 ppm, as well as three cases where gluten levels were below 20 ppm.

What did Nima test?

Nima compiled a set of 47 food items for testing, ranging from packaged foods to gluten-free items ordered at restaurants. Out of 47 foods, 25 were restaurant foods and 22 packaged goods.

Twenty-five restaurant items were ordered and selected for inclusion based on online reviews that had complaints of contamination, items previously ordered by us and tested as containing gluten, or items labeled gluten-free. Restaurant purchases were made by calling or ordering with a note that these food items were for someone with either a “severe gluten allergy” or Coeliac disease.

For the 22 packaged goods tested, items were chosen based on a few criteria: top items from consumer surveys, inbound requests for testing, online reports of cross-contamination/sickness, items with gluten-free ingredients without a gluten-free label, items that were flagged as containing wheat and foods produced on equipment also used for wheat products.

How did they sample and test Nima’s chemistry?

Nima partnered with two labs: Bia Diagnostics, a lab with 30 years’ laboratory experience and nearly 20 years in food allergen testing, and BioAssaySystems, a well-known leader in the development of innovative and high-throughput assays and assay kits. Two samples of each of the items were taken, with one sample sent to Bia Diagnostics and another sent to BioAssaySystems.

Bia tested its samples with the R-Biopharm R7001 kit, an AOAC-approved kit for gluten testing often considered the industry standard. The limit of detection (LOD) for this assay is 2 ppm, and limit of quantification (LOQ) is 5 ppm. This means that in results greater than 5 ppm, there is a high degree of statistical confidence in the absolute value of gluten present. If the level is under 2 ppm, it may or may not contain gluten — there is a much lower level of statistical confidence in the value. As a result, the tests Bia conducted with the R-Biopharm 7001 kit report the actual parts per million for the amount of gluten present when greater than 5 ppm. If the sample contains more than 84 ppm, due to the limited dynamic range of the assay, you will only see >84 ppm and not a specific number in the reporting.

The set of samples tested with Nima’s technology were sent to BioAssaySystems. There, these food items were evaluated using the proprietary sample preparation and the Nima proprietary antibody and assay designed specifically to work with the Nima device.

BioAssaySystems reported the results of each test as containing gluten or no gluten detected, just as someone using Nima would see. Each item is reported in the tables below with the indicator someone using the device would see: Gluten Found (any gluten detected) or a smile (the sample contains less than 20 ppm of gluten).

Results

Restaurant foods

The raw data below shows all results from both Nima (as conducted by BioAssaySystems) and R-Biopharm (as conducted by Bia) tests for each item. Both Nima and R-Biopharm results report five items as containing gluten. However, only four items are the same between the two tests. Three items tested as having greater than 10 ppm of gluten with R-Biopharm. Each of these would have reported a frown with Nima. Additionally, one item at 3.6 ppm as identified by R-Biopharm would also have yielded a frown from Nima.

A sample identified at 7 ppm with the R-Biopharm test resulted in a gluten free from Nima. However, this item technically qualifies as gluten free based on U.S. FDA standards. Another item, which Nima labelled as having contained gluten, R-Biopharm reported as less than 5 ppm.

Restaurant foods data

Packaged foods

The raw data below shows all results from both Nima (as conducted by BioAssaySystems) and R-Biopharm (as conducted by Bia) tests. No discrepancies were found.

Packaged foods data

Conclusion

Based on this testing, we can say that Nima compares well against the leading lab test, as evident by this round of testing.

Research reported in this publication was partially supported by the National Institute Of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK105770. The content is solely the responsibility of the authors, and does not necessarily represent the official views of the National Institutes of Health.

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