Romer Labs® has announced that both test kit lines, the AgraQuant® Gluten G12 ELISA test and the AgraStrip® Gluten G12 lateral flow test have obtained important approvals:

In the AOAC® Performance Tested Method program, the AgraStrip® Gluten G12 Test Kit was compared to the AOAC OMA reference method 2012.01. Certification was granted by the Research Institute for certain food as well as environmental matrices.

The AgraQuant® Gluten G12 ELISA test has been accepted by AOAC International as Official First Action method 2014.03 and has been approved as AACC International Method 38-52.01 for the detection of gluten.

All requirements to comply with the U.S. Food and Drug Administration (FDA) gluten-free labeling rule, demanding that only food that contains less than 20 parts per million (ppm) gluten can be labeled as gluten free, are met. Furthermore, the AgraQuant® Gluten G12 Elisa test fullfills the Codex Standard 118-1979 requirements for an effective and precise analytical method needed to determine the gluten concentration in foods and raw materials.

“Having obtained these two important approvals for our AgraQuant® Gluten test, we are offering the food industry an externally validated testing solution that helps them to fulfill all criteria and requirements set by the FDA and the Codex Standard”, states Lukas Frank, Product Manager for Allergens at Romer Labs.

All Romer Labs Gluten G12 test kits incorporate the monoclonal G12 antibody, which was raised against the main immunotoxic fragment triggering celiac disease–the so called 33-mer. Celiac patients must strictly avoid gluten in their diet and therefore need to rely on correct labelling of foods. According to the Codex Standard 118-1979 foods labeled as
“Gluten-Free” must not exceed the threshold level of 20 mg/kg gluten. To comply with this regulation effective and precise analytical methods are needed to determine the gluten concentration in foods and raw materials. Based on all the collaborative study results a detection limit of 4 mg gluten/kg was calculated for rice-based products analysis with the AgraQuant® Gluten test. The method also showed excellent precision in the concentration range of most interest (20 mg/kg and above), where it has to be decided whether a sample is gluten-free or not.

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