We are delighted to share the press release, below, detailing the AOAC Research Institute Performance Tested MethodTM certification that GlutenTox® Pro has just received for the detection of gluten in foods and on surfaces. If you’d prefer, download the press release in PDF form here: GlutenTox Pro – AOAC-RI Press Release 2015
Emport LLC, in partnership with Biomedal Diagnostics, is pleased to announce that the GlutenTox® Pro test kit has received AOAC Research Institute Performance Tested MethodTM certification for the detection of gluten in foods and on surfaces.
- GlutenTox® Pro awarded AOAC-RI approval for foods and surfaces.
- Currently validated against more matrices than any other lateral flow / rapid gluten test kit. Matrices include 5 foods and 5 environmental surfaces: bread, rice flour, pâté, rolled oat, yogurt, food-grade painted wood, plastic, rubber, sealed ceramic, and stainless steel.
- Validation study showed no cross-reactivity (false positives) and no false negatives, as well as 100% specificity and 100% sensitivity.
- GlutenTox® Pro uses the G12 antibody and offers a simple, rapid, and accurate method of detecting gluten contamination.
August 1, 2015 – Pittsburgh, PA and Seville, Spain – Emport LLC and Biomedal Diagnostics are pleased to announce that the AOAC Research Institute has awarded the popular GlutenTox® Pro gluten test kits status as a Performance Tested MethodTM for detecting gluten in foods and on surfaces. The test kit holds license number 061502.
GlutenTox® Pro is widely used in manufacturing facilities worldwide to ensure that incoming ingredients, food production environments, and final products are gluten-free and safe for celiac consumption. The kit uses the G12 antibody and can detect gluten in foods at the trace level of 5ppm, or can be set to a higher threshold of 10, 20 or 40ppm in keeping with various regulatory requirements worldwide. When used on surfaces, GlutenTox® Pro can detect as little as 16 ng of gluten.
Thousands of tests were performed as a part of this validation, ensuring that GlutenTox® Pro produces accurate, reliable results across a wide variety of matrices and under a wide variety of testing environments. In tests on foods, GlutenTox® Pro demonstrated 100% specificity and 100% sensitivity at every level of spiked gluten contamination and every test threshold. Precise amounts of gluten were added to test samples of bread, rice flour, pâté, yogurt, and rolled oat at levels of 0, 3, 8, 15, 25, 45 and 10,000ppm, and then these samples were tested with GlutenTox® Pro to the thresholds of 5, 10, 20 and 40ppm. In each of these tests, GlutenTox® Pro provided accurate analysis.
Each of the 5 surfaces validated under this certification – food-grade painted wood, plastic, rubber, sealed ceramic, and stainless steel – was tested when completely clean (blank) and when sprinkled with low (16ng/16cm2) and high (400ng/16cm2) amounts of gluten. GlutenTox® Pro was able to detect as little as 16ng of gluten across matrices.
“Our customers are brands and manufacturing facilities that trust GlutenTox® Pro to keep their gluten-free items safe, and their customers are individuals who rely on gluten-free foods and beverages to stay healthy,” said Emily Kaufman, president of Emport LLC. “Performance Tested MethodTM certification by AOAC-RI offers additional peace of mind to anyone using GlutenTox® Pro.”
The adjustable sensitivity and low detection limits explain much of GlutenTox® Pro’s appeal, but the kit is also popular because of its quick turnaround (<20 minutes for foods, <11 minutes for surfaces) and user-friendly interface. There is no equipment required to use GlutenTox® Pro to test for gluten, nor does the tester need prior laboratory experience. Results are easy to interpret and each test strip has a built in control mechanism. The G12 antibody, developed to identify the highly immunotoxic 33-mer peptide of the alpha-gliadin molecule, is a robust method for identifying those items with a strong likelihood of triggering a response in celiac patients.
The number of people avoiding gluten worldwide continues to increase, whether because of celiac disease, non-celiac gluten sensitivity, or other health concerns. For people with celiac disease, the only appropriate treatment is a rigorous, lifelong avoidance of even small amounts of gluten-containing grains. Many countries carefully regulate the amount of accidental gluten contamination permissible in a food that is labeled gluten-free, to protect the health of these people. In the USA and Canada, as in many other countries, this threshold is set to 20ppm.
GlutenTox® Pro is a critical part of any HACCP or Allergen Control Plan that is designed to prevent accidental gluten contamination of gluten-free foods. It is manufactured and globally distributed by Biomedal Diagnostics, and available within the United States and Canada exclusively via Emport LLC and their affiliated agents.
About Emport LLC
Emport, LLC was founded in 2011 with the motto: More safe food, more happy people. Initially focused on increasing the health and safety of gluten-free products via the GlutenTox line of test kits, Emport has expanded its offerings to include other quality control kits including AlerTox Sticks allergen detection strips and OleoTest. For more information please visit www.emportllc.com.
This method’s performance was reviewed by AOAC Research Institute and was found to perform to the manufacturer’s specifications. The AOAC Research Institute (AOAC-RI) was incorporated in 1991 as a wholly owned subsidiary of AOAC INTERNATIONAL. The AOAC-RI serves as an independent, third-party, nongovernment administrator of AOAC conformity assessment programs including the AOAC Performance Tested MethodsSM (PTM) and Official Methods of AnalysisSM (OMA) programs for alternative and sole source methods. For more information, visit www.aoac.org