ELISA Technologies Inc.

Gainesville, FL, United States

ELISA Technologies Inc.

Gainesville, FL, United States

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Allred L.K.,ELISA Technologies Inc. | Park E.S.,ELISA Technologies Inc. | Popping B.,Eurofins | Williams K.,U.S. Food and Drug Administration | Marrow T.,Laboratory Services Agriculture and Food Laboratory
Journal of AOAC International | Year: 2012

The EZ Gluten® assay is a rapid immunochromatographic screening method for qualitative detection of gluten in raw and cooked foods and beverages and on environmental surfaces. This AOAC Performance Tested MethodSM study evaluated the EZ Gluten assay as an effective method for the detection of gluten in four selected matrixes: rice flour, cooked dough, beer, and dog food. In addition, the method was evaluated for its effectiveness in detecting gluten contamination of ≥1 μg/2 in.2 (25 cm2) stainless steel surface area. The EZ Gluten demonstrated 100% specificity [probability of detection (POD) 0.00, confidence interval (CI) 0.00-0.01] and 99% sensitivity (POD 0.99, CI 0.97-0.995) at the 10 ppm level for all four matrixes, and 100% specificity (POD 0.00, CI 0.00-0.11) and sensitivity (POD 1.00, CI 0.886-1.00) at the 1 mg level on the stainless steel surface. Independent laboratory testing confirmed the internal validation results in one matrix and on the stainless steel surface. Lot-to-lot, stability, and robustness studies provided evidence that the EZ Gluten is a rugged, consistent method for the detection of gluten at levels as low as 10 ppm. © 2012 Publishing Technology.


Allred L.K.,ELISA Technologies Inc | Ritter B.W.,ELISA Technologies Inc
Journal of AOAC International | Year: 2010

Gluten sensitivity affects nearly 1% of the population in the United States and Europe. To help these consumers avoid the health issues that result from gluten consumption, the U.S. Food and Drug Administration is attempting to establish a definition and testing protocol for gluten-free foods. Establishing this protocol depends on accurate tests that can detect and quantitate gluten. There are multiple immunoassays available for the quantitation of gluten, and most are based on one of two antibodies. These antibodies, known as the Skerritt and R5 antibodies, were examined through the use of four commercial test kits for their ability to detect the two main components of gluten, known as gliadin and glutenin, in wheat. Commercial tests based on the Skerritt and R5 antibodies demonstrated differing affinities for gliadin and glutenin, with the Skerritt-based tests recognizing glutenins more strongly, and the R5 tests recognizing gliadins more strongly. Analysis of 40 processed food samples of unknown gluten content revealed differences in gluten detection and quantitation between the Skerritt-based and R5-based assays. These discrepancies in test results may be the result of the antibody affinity differences between the Skerritt- and R5-based tests, the solubility differences between gliadins and glutenins, or a combination of these and other factors.


Allred L.K.,ELISA Technologies Inc. | Voyksner J.A.S.,Immunogenics | Voyksner R.D.,LCMS Ltd
Journal of AOAC International | Year: 2014

To meet the need for the detection and quantitation of barley gluten in beer qualitative screening and quantitative immunoassays based on the monoclonal antigluten antibody 401/21 (Skerritt) were validated in a single laboratory. Sample replicates were tested at each stage of beer production using multiple yeast strains and methods of end-stage protein removal. Quantitation was performed using barley-specific standards based on barley flour extracts. Immunoassay results were confirmed using LC/MS/MS for barley-specific peptides. The LOD for the qualitative screening test was 5 mg/L barley gluten. Recovery for the barley-spiked worts ranged from 81 to 128% in the quantitative ELISA assay; the LOD was <1 mg/L, and the LOQ was 5 mg/L. Both screening and confirmation methods were found to be fit for the purposes of detection of low levels of barley gluten in beer.


PubMed | ELISA Technologies Inc.
Type: Comparative Study | Journal: Journal of AOAC International | Year: 2010

Gluten sensitivity affects nearly 1% of the population in the United States and Europe. To help these consumers avoid the health issues that result from gluten consumption, the U.S. Food and Drug Administration is attempting to establish a definition and testing protocol for gluten-free foods. Establishing this protocol depends on accurate tests that can detect and quantitate gluten. There are multiple immunoassays available for the quantitation of gluten, and most are based on one of two antibodies. These antibodies, known as the Skerritt and R5 antibodies, were examined through the use of four commercial test kits for their ability to detect the two main components of gluten, known as gliadin and glutenin, in wheat. Commercial tests based on the Skerritt and R5 antibodies demonstrated differing affinities for gliadin and glutenin, with the Skerritt-based tests recognizing glutenins more strongly, and the R5 tests recognizing gliadins more strongly. Analysis of 40 processed food samples of unknown gluten content revealed differences in gluten detection and quantitation between the Skerritt-based and R5-based assays. These discrepancies in test results may be the result of the antibody affinity differences between the Skerritt- and R5-based tests, the solubility differences between gliadins and glutenins, or a combination of these and other factors.


PubMed | ELISA Technologies Inc.
Type: Journal Article | Journal: Journal of AOAC International | Year: 2012

The EZ Gluten assay is a rapid immunochromatographic screening method for qualitative detection of gluten in raw and cooked foods and beverages and on environmental surfaces. This AOAC Performance Tested Method study evaluated the EZ Gluten assay as an effective method for the detection of gluten in four selected matrixes: rice flour, cooked dough, beer, and dog food. In addition, the method was evaluated for its effectiveness in detecting gluten contamination of > or =1 microg/2 in.2 (25 cm2) stainless steel surface area. The EZ Gluten demonstrated 100% specificity [probability of detection (POD) 0.00, confidence interval (CI) 0.00-0.01] and 99% sensitivity (POD 0.99, CI 0.97-0.995) at the 10 ppm level for all four matrixes, and 100% specificity (POD 0.00, CI 0.00-0.11) and sensitivity (POD 1.00, CI 0.886-1.00) at the 1 microg level on the stainless steel surface. Independent laboratory testing confirmed the internal validation results in one matrix and on the stainless steel surface. Lot-to-lot, stability, and robustness studies provided evidence that the EZ Gluten is a rugged, consistent method for the detection of gluten at levels as low as 10 ppm.

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