An Integrated, Accurate, Rapid, and Inexpensive Handheld Consumer Gluten Detector

An Integrated, Accurate, Rapid and Inexpensive Handheld Consumer Gluten Detector Pain Point: 1% of the US population suffers from celiac disease (Han, 2013 PNAS 110: pp.13073), and an additional 6% suffers from some form of intolerance to dietary gluten (Sapone, 2012 BMC Medicine 10: pp.13). In addition, 3.7% of adults and 6-8% of children under 4 have food allergies. Food allergy accounts for 35-50% of emergency room visits for anaphylaxis (NIAID 2006 report). Specifically for gluten, despite the increasing availability of gluten-free options, consumers continue to become ill from unintentional gluten ingestion, largely due to cross-contamination of foodstuffs during food manufacturing and preparation processes, and inadequate food labeling and testing mechanisms (Thompson, 2010 J Am Diet Assoc 110:pp.937). Traditional gluten tests are (1) complicated - with multiple processing steps and results that are difficult to interpret; (2) expensive - costing $12.5 to $16 per test; and (3) time consuming - taking >15 min per test. Currently, there is no consumer-oriented product that gluten sensitive individuals can use to ensure their food safety. Technological Innovation: Our solution is an all-in-one, handheld device, called the NimaTM, which integrates food processing, gluten detection, result interpretation, and data transmission, thereby allowing consumers to easily test their food for allergens. This test will not only enable consumers to verify the safety of foods while cooking at home or dining out, but also allow parents to confidently and safely provide food for their children at home. Consumers only need to put a small sample (~0.5 grams) into the disposable cassette, which is then inserted into the reader. The device internally grinds the food, extracts the gluten with our propriety extraction solution, and performs the immunoassay. The built-in reader then analyzes the test strip, giving the user a binary result, which is based upon the FDA-defined threshold of 20 ppm gluten. Our device is expected to analyze gluten content in both simple and complex food matrices, with a Limit of Detection