Nima’s founding team met at MIT, and the product was built by engineers and doctorates from MIT, Caltech, Stanford and Dartmouth, with experience building consumer products at companies like Nike, Google and Johnson & Johnson, and medical devices at companies like Cepheid and Agamatrix.
Nima was developed by adapting antibody-based chemistry used for protein or allergen detection, designed into a hardware device that is portable and easy to use, and using electronic sensors and proprietary algorithms to detect test results. The primary criteria considered when designing Nima were sensitivity and specificity to gluten, speed, portability and ease of use.
Nima’s antibody-based chemistry
An antibody is a large, y-shaped protein that recognizes and binds to a specific target protein. Antibodies are routinely used to detect specific proteins in chemistry lab tests.
The Nima chemistry team developed a pair of antibodies specifically for the detection of gluten. There are existing gluten antibodies on the market, but none of them met the sensitivity and specificity requirements that we needed for Nima. The Nima 13F6 and 14G11 antibodies bind to a portion of the gluten protein, called the 33-mer fragment of gluten, which is known as the “toxic” portion of the gluten protein that causes an autoimmune response. Nima’s 13F6 and 14G11 antibody system was evaluated and determined to be more sensitive in a standard lab test than one of the well-recognized gold standard antibodies currently used on the market.
Nima’s test capsuleTest strip
Each Nima capsule contains a test strip preloaded with our antibodies. If gluten is present in the food being tested, the antibodies will bind to the gluten proteins and present a signal change on the strip that is detected by the Nima electronics and processing algorithm.Liquid extraction buffer
When gluten is present in food, the gluten protein molecules are trapped inside other food molecules surrounding them. In order to detect gluten in food, gluten molecules need to be isolated and extracted from the rest of the food molecules.
The Nima team designed an extraction buffer solution that is capable of breaking apart the bonds between gluten and other food molecules, leaving the gluten itself in a liquid solution, which reacts to the strip.Grinding and mixing mechanism
When testing food for gluten, there are several mechanical steps necessary to deliver a result. Screwing the cap shut begins a grinding process on the food to break the food into small particles to increase the amount of surface area exposed to the buffer solution.
After the food is ground, the final twist of the cap will expose the food to the extraction buffer solution. Nima uses a motor to mix the food and the buffer in the capsule. Once the mixing is complete, the solution passes onto the test strip loaded with antibodies, where the chemical reaction begins.
Nima’s sensor and algorithm
As the test strip develops, an electronic sensor and associated algorithm detect the test result. Reading the result electronically eliminates the need for a trained operator to be evaluating the results (as is required with other lab-format tests) and reduces the likelihood of misinterpreting results (as often happens with at-home pregnancy tests). The algorithm is improved and updated via Bluetooth connection through the Nima mobile app. The algorithm can be updated by downloading the latest firmware updates from the app.
The Nima system has been extensively tested with thousands of tests in our labs, in the field and in third-party labs. In our own internal testing of hundreds of food tests, Nima demonstrates the following accuracy:
- For foods containing gluten at or above 20 ppm, Nima reported “gluten found” 99 percent of the time.
- For foods containing below 2 ppm, Nima reported “gluten found” 7.8 percent of the time.
We designed Nima to be more sensitive to minimize false smiles (gluten-free when gluten is present at or above 20 ppm). Learn more about our threshold here.
A full report on the efficacy of Nima is pending publication in a peer-reviewed journal, and will be shared with our community when available.