On August 5, 2013, the US FDA released their final ruling on the definition of the term “gluten-free” in food labeling.  This regulation requires that foods labeled gluten-free must contain less than 20 ppm of gluten.

The FDA further ruled that any scientifically validated method for the detection of gluten may be used to verify a manufacturer’s gluten-free claim.  Both the ELISA Technologies EZ Gluten assay and AllerTek ELISA have been validated through the AOAC Performance Tested Methods program to meet this requirement.

The full text of the final ruling may be found here:  FDA Final Gluten-Free Ruling

GAINESVILLE, Fla., September 3, 2012 – ELISA Technologies, Inc., has announced that its ALLER-TEK^® Gluten ELISA test kit has earned Performance-Tested Method^SM (PTM) certification from the AOAC Research Institute (AOAC RI).  The ALLER-TEK Gluten ELISA was designed to quantitate gluten from wheat, rye or barley in raw ingredients and processed foods and beverages.

The AOAC granted Performance-Tested Methods^SM status after trials at ELISA Technologies and an independent laboratory demonstrated that the method delivered consistent, accurate results that would allow food companies and consumers to test their products for gluten at or above 5 parts per million (ppm). For more than 120 years, AOAC has been a proactive, worldwide provider and facilitator in the development, use and harmonization of validated analytical methods and laboratory quality assurance programs and services.

Gluten is the common name for a combination of water-insoluble proteins (gliadin and glutenin) found in the seeds of wheat, rye and barley. Sensitivity to gluten affects nearly 1% of the populations of Europe and North America. Persons with gluten sensitivity, or celiac disease, have a heightened immunologic response to ingested gliadin and glutenin, resulting in a range of symptoms.

For persons with gluten sensitivity, celiacs, the only treatment for these conditions is adopting a gluten-free diet, avoiding foods containing wheat, rye, barley and other related cereal grains.

According to the Codex Standard, food labeled “gluten free” may not contain wheat, rye, barley, oats, spelt, kamut, or crossbreed varieties, and its gluten level may not exceed 20 parts per million (ppm).

For more information about the ALLER-TEK^® Gluten ELISA, please visit http://www.elisa-tek.com , call (352) 337-3929 or email: info@elisa-tek.com

Requirements for Official Establishments To Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall Procedures, and Document Certain Hazard Analysis and Critical Control Points System Plan Reassessments

DATES: Effective Date: May 8, 2012.

SUMMARY: The Food Safety and Inspection Service (FSIS) is implementing provisions of the Food, Conservation, and Energy Act of 2008 by amending the Federal meat and poultry products inspection regulations to require official establishments to promptly notify the appropriate District Office that an adulterated or misbranded meat or poultry product has entered commerce; require official establishments to prepare and maintain written procedures for the recall of all meat and poultry products produced and shipped by the establishment; and require official establishments to document each reassessment of the establishment’s Hazard Analysis and Critical Control Point (HACCP) plans.

ABSTRACT: Under this final rule, FSIS is requiring three information collection activities. First, FSIS requires that official establishments notify the appropriate District Office that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has happened. FSIS is requiring that this notification occur as quickly as possible, but within 24 hours of the establishment learning or determining that an adulterated or misbranded product received by or originating from it has entered commerce. Second, FSIS is requiring that establishments prepare and maintain written procedures for the recall of meat and poultry products produced and shipped by the establishment for use should it become necessary for the establishment to remove product from commerce. These written recall procedures have to specify how the establishment will decide whether to conduct a product recall and how the establishment will affect the recall, should it decide that one is necessary. Finally, FSIS is requiring that establishments document each reassessment of the establishment’s HACCP plans. FSIS requires establishments to reassess their HACCP plans annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Under this rule, establishments must document each reassessment, the reasons for any changes to the HACCP plan, or the reasons for not changing the
HACCP plan. For annual reassessments, if the establishment determines that no changes are necessary, documentation of this determination is not necessary.
The recall procedures and reassessment documentation will have to be made available for official review and copying.

To learn more: http://www.fsis.usda.gov/

GAINESVILLE, Fla., June 10, 2011 – ELISA Technologies, Inc., announced that its EZ Gluten^® Test Kit has earned Performance-Tested Methods^SM (PTM) certification from the AOAC Research Institute (AOAC RI).  EZ Gluten^® was developed to help food industry and consumers detect gluten in food and beverages. The EZ Gluten^® Test Kit delivers highly accurate results in about 15 minutes.

EZ Gluten^® is an easy to use kit that will quickly detect the presence of gluten in foods and beverages. It is sensitive enough to detect levels of gluten as low as 10 parts per million (ppm.) The AOAC granted Performance-Tested Methods^SM status after trials at ELISA Technologies and an independent laboratory demonstrated that the method delivered consistent, accurate results that would allow food companies and consumers to screen their products for gluten at or above 10 parts per million (ppm.) For more than 120 years, AOAC has been a proactive, worldwide provider and facilitator in the development, use and harmonization of validated analytical methods and laboratory quality assurance programs and services.

Gluten is the common name for a combination of water-insoluble proteins (gliadin and glutenin) found in the seeds of wheat, rye and barley. Sensitivity to gluten affects nearly 1% of the populations of Europe and North America. Persons with gluten sensitivity, or celiac disease, have a heightened immunologic response to ingested gliadin and glutenin, resulting in a range of symptoms.

For persons with gluten sensitivity, celiacs, the only treatment for these conditions is adopting a gluten-free diet, avoiding foods containing wheat, rye, barley and other related cereal grains.

EZ Gluten^® offers celiac disease sufferers and food manufacturers alike a way to rapidly and accurately test food or beverages for the presence of gluten. Detecting as low as 10 ppm, EZ Gluten^® can insure compliance with the Codex Alimentarius Commission Standard 118-1979 which applies to foods for special dietary uses that have been formulated, processed or prepared to meet the special dietary needs of people intolerant to gluten.

According to the Codex Standard, food labeled “gluten free” may not contain wheat, rye, barley, oats, spelt, kamut, or crossbreed varieties, and its gluten level may not exceed 20 parts per million (ppm).

For more information about EZ Gluten^® please visit http://www.ezgluten.com , call (352) 337-3929 or email: gluten@elisa-tek.com

Since 1991, ELISA Technologies, Inc. has provided manufacturers, government agencies, and consumers worldwide with reliable and accurate testing solutions.  We offer an extensive collection of testing options which include lateral flow rapid test kits, quantitative analytical testing kits, swabbing kits and our in-house analytical testing services. With a wide variety of testing options, companies are able to prevent expensive product recalls, provide confident brand name protection, and assure consumer confidence while acting in accordance with product labeling requirements.

ELISA Technologies, Inc. developed the EZ Gluten® lateral flow test for use by consumers and manufacturers.  The EZ Gluten® test is an easy to use kit that will quickly detect the presence of gluten in foods and beverages. It is sensitive enough to detect levels of gluten as low as 10 ppm. This simple test is small and portable enough for use in restaurants or when traveling, and is sensitive and robust enough for use in industry and food manufacturing. It can be used to test individual ingredients in foods, or test finished, raw or cooked products.  EZ Gluten® surface swabs allow manufactures and producers to ensure products are not cross-contaminated during the manufacturing process.

The ALLER-TEK Gluten Test Kit is a quantitative 96-well ELISA assay with a limit of quantitation of 5ppm. It detects gluten in food ingredients as well as in prepared and processed foods and beverages. It can detect gluten from wheat, rye and barley. This kit is for industry use and requires lab equipment for data analysis.

Both the EZ Gluten and Aller-Tek test kits use the anti-omega gliadin antibody developed by Skerritt & Hill for detection. This antibody, which detects both gliadin and glutenins, is the basis of the AOAC Official Method for gluten detection at the 156ppm level.

ELISA Technologies, Inc. also offers confidential commercial testing services employing immunoassays for gluten, prolamins and other allergens. We are a professional full-service A2LA (ISO 17025) accredited laboratory.   We offer a two-day turn around on results.

For more information on our gluten testing solutions, contact us.

Our new Scope of Accreditation is out. ELISA Technologies is A2LA accredited to ISO 17025 in Meat Speciation and Allergen Testing.

Download the Scope of Accreditation >>>Scope of Acreditation <<<



This new EZ Gluten results cards addresses questions regarding high positives in your samples.

We, at ELISA Technologies, Inc., strive to give our customers unparalleled support experience. If you have any questions please do not hesitate to contact us.