Romer Labs Gluten G12 rapid tests obtain AOAC approval

• The AgraStrip Gluten G12 lateral flow test obtains AOAC-RI approval
• The AgraQuant® Gluten G12 ELISA test is now an AOAC Official Method and
• approved by the American Association of Cereal Chemists (AACCI)
• The AgraQuant® Gluten G12 ELISA has proven in an validation from an influential third party that the delivers accurate and reliable results helping food producers to comply to standards and requirements set by the FDA and the Codex Alimentarius

Tulln, Austria September 30, 2014 – Romer Labs®, a leading global food-safety diagnostic company, is proud to announce 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 Romer Labs 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 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.

Romer Labs Allergen Solutions:

With its LFD and ELISA testing solutions Romer Labs has the largest allergen product portfolio currently available on the market and offers tailored one-stop solutions for all diagnostic needs and outstanding support for customers on an international level. With fully accredited ISO 17025 service laboratories in Austria, United Kingdom and United States, Romer Labs is also offering analytical services for a wide range of allergens.

The AgraQuant® Allergen product line consists of 20 sandwich ELISA test kits for the accurate quantitative determination of allergens in food, rinse water and swabs samples. With its two approvals (AOAC-OMA & AACCI) the AgraQuant® Gluten G12 test kit is for sure the flagship of this line.

The AgraStrip® Allergen product line consists of immunological rapid tests in lateral flow format for the detection of allergens in food, rinse water and swab samples. The fact that no additional equipment is need makes that AgraStrip® Allergen line the perfect on- side tool for the detection of trace amounts of allergens. The flagship of this line is the AOAC-RI approved AgraStrip® Gluten G12 test kit.

About Romer Labs:
Romer Labs, founded in Washington, MO, in 1982, is a leading provider in diagnostic solutions for food and feed safety. It develops, manufacturers and markets rapid test kits for food allergens, food pathogens, mycotoxins, veterinary drug residues and other food contaminants. The company also operates four accredited full-service laboratories on three continents. Romer Labs has facilities in Austria, Brazil, China, Malaysia, Singapore, the UK and the USA. For more than 30 years, Romer Labs has been a trusted partner for the food and feed industry worldwide. www.romerlabs.com

For further information, please contact:
Katharina WIESER
Division Marketing Officer
Romer Labs Division Holding GmbH Technopark 1
3430 Tulln, Austria
Tel: +43 2272 615 33 10
e-mail: [email protected] www.romerlabs.com