There are about 3 million people in the US who have Celiac Disease (CD) for which there is no cure and the only treatment is lifelong abstention from gluten containing foods (those containing wheat, rye, barley or their cultivars). There are many more individuals who have Non-Celiac Gluten Sensitivity (GS) who likewise require a gluten free (GF) diet. Many CD and GS sufferers depend on oat and oat based products to supplement their GF diet, but some cultivars can have a high degree of gluten contamination, especially from wheat and barley grains. Currently, food manufacturers using GF oats rely on Enzyme-Linked Immunosorbent Assay (ELISA) based methods to test for gluten contamination, but the existing commercially available test kits for detecting gluten utilize small sample test size portions resulting in high degrees of variability. Additionally, they do not give accurate results for gluten from all three major cultivars (wheat, rye, and barley), and users may get artificially high or low results depending on the source of gluten contamination.

Elution Technologies (ET) has developed a quantitative ELISA based method for the detection of gluten in oats and a variety of oat products. Unlike current methods, the ET Gluten ELISA utilizes a proprietary antibody that more accurately detects gluten from all three major cultivars, with a five gram sample size for reduced sample heterogeneity, and a total run time including preparation and extraction of less than 90 minutes. It has been evaluated by Bia Diagnostics for accuracy, specificity, repeatability and cross-reactivity, using oat flour samples spiked with wheat, rye or barley in known amounts. The test kit has shown to accurately quantify gluten from all three grains, when compared to measurements by the R-biopharm R7001 Gluten ELISA method (AACCI 38.50.01) and the Dumas protein method, with inter- and intra- lab coefficients of variance below 30%, showing no cross-reactivity to any tested oat cultivars. These results indicate that the ET Gluten ELISA method is suitable for manufactures of GF oats and oat products to quickly and accurately determine the gluten content of their products.