Grace Culhane

A Lab in Your Pocket

How and Why The Nima Sensor was Built

Nima founders Shireen Yates, Scott Sundvor, and Dr. Jingqing Zhang, Ph.D. met at MIT. Co-founder and CEO Shireen Yates was diagnosed with several food sensitivities during her time in college. Too often, the food she was eating made her sick. This was especially true in environments like restaurants or while traveling, when knowledge of what was in the food was difficult to obtain. The group came together and decided to start Nima out of a shared desire to improve the lives of people with food allergies.

Shireen and Scott had the idea of creating a rapid consumer test to help people with food allergies avoid the foods that were dangerous to their health. They worked with Dr. Zhang to determine the best scientific approach for addressing the problem. The passion to provide a real-time, real-life tool for people with food allergies in uncontrolled eating environments, combined with Dr. Zhang’s expertise in chemistry and instrument integration, led to the creation of the Nima Sensor.

The Chemistry Involved in The Nima Sensor

The chemistry and detection method used to create the device is firmly rooted in tradition. It is antibody-based, making it similar to the majority of lab tests used in food allergen testing. The antibody was then used in a lateral flow test format — the basis of many at-home pregnancy tests — since this design has an especially quick test time. To make the test even faster, the chemistry was modified to increase speed.

 

Some of the key aspects of the Nima chemistry are:

 
  • An improved lateral flow design that increases speed compared to standard tests
  • A buffer solution strong enough to extract allergens from foods with minimal handling, but compatible with the lateral flow test
  • Proprietary antibodies, with high sensitivity and specificity to each allergen
  • The ability to detect an allergen in foods as varied as ice cream, cookies and chicken as well, as the ability to process items that are raw, baked or roasted

We performed extensive development in order to ensure the best test performance possible. After a period of research, the team made adjustments that improved upon the design of the test. The team worked to optimize the geometry and flow parameters, as well as the protein concentrations and formulations and the buffer composition in order to decrease extraction time to under a minute. As with typical product development processes, the team used a phase gate approach that includes Design Validation Testing and Production Validation Testing.

 

These phases can take from months to years, depending on their complexity, with many trials and error cycles usually required to optimize the chemistry and the overall system. During our validation testing and now in our manufacturing, we have used lots of key components ensuring that we can produce the same product consistently and reliably. We perform quality control (QC) on individual components, throughout development and on all final lots produced to ensure safety and performance prior to release to customers.

 

Additionally, we do regular food testing and long term stability testing to ensure the product performs the same at the beginning and end of its expiration. As we learn new information, we adjust our processes and communicate information to our community that would impact their experience.

 

We also work with our customers to troubleshoot and address their testing needs, and update our procedures and instructions accordingly to ensure a positive and safe experience.  

 

The Nima Sensor Hardware and Components

 

From its beginnings it was clear that the testing method would need to be quite different from traditional food allergen testing. Clearly the system would need to be small, portable, light & easy to use without sacrificing accuracy. No one using this approach would be formally trained. It would need to be easy and intuitive.

 

Most people are used to having a consumer electronic device with them — we are a nation of cell phone users after all — maybe we could package the testing in a piece of hardware? In order to enable the chemistry, we would need the following to package it:

 
  • Capsule
  • Single-use to prevent cross-contamination between samples
  • Performs grinding and mixing of food for ease of use, without the need for external tools
  • Encloses and protects the chemistry components from potential contamination and non-ideal, variable environments
  • Reader
  • Able to detect the signal from the lateral flow test, even signals too faint for the naked eye to see.
  • Able to analyze the different signals resulting from testing various foods.  Foods with different characteristics such as density, viscosity, fat content, acidity behave in slightly different ways when interacting with the chemistry.
  • Able to precisely time the test run to maintain test result consistency (and so the user doesn’t have to set a timer)
  • Able to provide results in a consistent, clear manner
  • Able to produce clear, easy-to-interpret results. We designed Nima with a binary yes/no result which we represent by a smile or a “contaminant found” message for ease of understanding
 

Our Rigorous Testing, Validation and Ongoing Improvement Process

Although not an FDA-regulated device, we take safety seriously. Our team performs many of the assay performance tests used in medical device validation with our sensor. Our internal validation was referenced to ELISA (the industry laboratory standard – Enzyme Linked Immunosorbent Assay) testing, of the same food samples, through both in-house experts and industry regulation-approved labs.

 

In addition to our own internal testing process, we have had third-party testing done as well. It can take a year, if not more, for completed validation work to be published in a peer-reviewed journal. Because our internal results were comparable with the unpublished third-party validation data, and because the results demonstrated the sensitivity, specificity and accuracy needed for a successful test had been met by our scientific and industry advisors, we decided to release the product ahead of the journal publication.

 

Since that time we have had three peer-reviewed articles published related to Nima.

 

Our device hardware has gone through verification and validation testing and has a CE mark for safety and FCC certification as well.

 

Who is Nima Labs?

 

Nima Labs is a community of scientists, engineers, and dedicated professionals who understand the complexities involved in living an allergen-free life, as many of us have allergen sensitivities. Our goal is to provide a device with a high degree of reliability that will give allergen-sensitive consumers a useful guide in evaluating the safety of their foods at the dining table.

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