Main content area

An integrated, accurate, rapid, and economical handheld consumer gluten detector

Zhang, Jingqing, Portela, Steven Barbosa, Horrell, Joseph Benjamin, Leung, Alex, Weitmann, Dane Rene, Artiuch, John Boguslaw, Wilson, Stephen Michael, Cipriani, Monica, Slakey, Lyndsie Katherine, Burt, Aquanette Michele, Dias Lourenco, Francisco Javier, Spinali, Marc Stephen, Ward, Jonathan Robert, Seit-Nebi, Alim, Sundvor, Scott Erik, Yates, Shireen Natasha
Food chemistry 2019 v.275 pp. 446-456
celiac disease, confidence interval, cross reaction, detection limit, food processing, food safety, foods, gliadin, gluten, gluten-free diet, immunoassays, monoclonal antibodies, portable equipment, United States
Celiac disease, characterized by autoimmune reactions to dietary gluten, affects up to 3 million in the US and approximately 0.5%–1% globally. A strict, lifelong gluten-free diet is the only treatment. An economic, simple, accurate, rapid and portable gluten testing device would enable gluten-sensitive individuals to safeguard their food safety. We developed a novel solution, Nima™, a gluten sensor that integrates food processing, gluten detection, result interpretation and data transmission in a portable device, detecting gluten proteins at or below the accepted 20 ppm threshold. We developed specific monoclonal antibodies, an optimized lateral flow immunoassay strip, and one-step aqueous extraction. Compared with reference R5, NimaTM antibodies (13F6 and 14G11) had 35- and 6.6-fold higher gliadin affinities, respectively. We demonstrated device performance using a comprehensive list of foods, assessing detection sensitivity, reproducibility, and cross-reactivity. Nima™ presented a 99.0% true positive rate, with a 95% confidence interval of 97.8%–100%.