The AgraStrip Gluten G12 lateral flow test was given AOAC-RI approval and the AgraQuant Gluten G12 ELISA test received AOAC Official Method and approval by the American Association of Cereal Chemists (AACCI).
The firms’ AgraStrip Gluten G12 Test Kit was compared to the AOAC Official Methods of Analysis (OMA) reference method 2012.01 in the AOAC Performance Tested Method (PTM) program.
Certification was granted by the Research Institute for food as well as environmental matrices (stainless steel), including bread spiked with gluten, rice flour and gluten-free items such as cookies, ice cream and chocolate.
The AgraQuant Gluten G12 ELISA test was accepted by AOAC International as Official First Action method 2014.03 and was approved as AACC International Method 38-52.01 for detecting gluten.
Lukas Frank, product manager for allergens at Romer Labs, told FoodQualityNews.com that it is important for the customer that the method is validated on an international level.
“The validation study was divided between internal, which is us at Romer Labs, and an external study by an independent lab. The study spiked bread mix and then it was baked as normal to see if the Agrastrip could still do the detection," he said.
“Gluten is a protein and ELISA includes an antibody which detects the protein which causes the allergy. With PCR you can’t be sure when you find the protein DNA you will also find the protein there.
“Mass Spectrometry is a good method but it is expensive for a food producer to perform on their own, time is money and they need answers quick. Our test gives answers quickly and you don’t need to send samples off site.”
Gluten PPM levels
Requirements to comply with the US Food and Drug Administration (FDA) gluten free labeling rule that only food that contains less than 20 parts per million (ppm) gluten can be labeled as gluten free, are met, said the firm.
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 precise analytical methods are needed to determine the gluten concentration in foods and raw materials, said Romer Labs.
Based on 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 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.
Frank said the tests help the food industry fulfill all criteria and requirements set by the FDA and the Codex Standard.
“The threshold for gluten is 20 ppm so for us it is important to do research as it makes the tests better and more accurate. The aim is a Limit of Detection (LOD) which is very low so the food producer is sure there is no allergen inside its product,” he said.
“The difficulty is not knowing where to set internal levels for products. In the EU market food producers can set the LOD for a product by the LOD of the kit.
“In the US the threshold is 5 ppm of the allergen which is sufficient enough.”
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 avoid gluten in their diet and need to rely on correct labelling of foods.