RESUMEN
Romer Labs , Inc. developed an immunochromatographic lateral flow assay for the qualitative detection of gluten in raw ingredients, processed foods, finished food products, and environmental surfaces, using the G12 antibody developed by Belén Morón. The G12 antibody targets a 33-mer peptide which is resistant to enzymatic digestion and heat denatiuration, as well as being the fragment of the gliadin protein.to which celiac disease sufferers react, making it a reliable analytical marker. This study was performed to validate the AgraStrip® GlutenG12 assay method under the guidance of the AOAC Peiformance Tested MethodsSM (PTM) program against AOAC Official Method of AnalysisSM 2012.01 in rice flour, bread, cookie, ice cream, and chocolate matrixes spiked with either purified gliadin or wheat gluten standard at 0, 3, 8, 15, and 25 ppm concentrations and tested at the 5, 10, and 20 ppm assay thresholds, as well as on, environmental surfaces. Stability, robustness, variation, and lot consistency studies were performed by spiking wheat gluten into a rice flour matrix at 0 and 15 ppm concentrations. The AgraStrip Gluten G12 assay was rigorously evaluated during this study and demonstrates its suitability as an AOAC PTM-certified gluten detection method.
Asunto(s)
Cromatografía de Afinidad/métodos , Análisis de los Alimentos/métodos , Glútenes/análisis , Anticuerpos Inmovilizados/química , Pan/análisis , Cacao/química , Harina/análisis , Gliadina/análisis , Helados/análisis , Oryza/químicaRESUMEN
The present interlaboratory comparison study involved nine laboratories located throughout the world that tested for 24 regulated and non-regulated mycotoxins by applying their in-house LC-MS/MS multi-toxin method to 10 individual lots of 4 matrix commodities, including complex chicken and swine feed, soy and corn gluten. In total, more than 6000 data points were collected and analyzed statistically by calculating a consensus value in combination with a target standard deviation following a modified Horwitz equation. The performance of each participant was evaluated by a z-score assessment with a satisfying range of ±2, leading to an overall success rate of 70% for all tested compounds. Equal performance for both regulated and emerging mycotoxins indicates that participating routine laboratories have successfully expanded their analytical portfolio in view of potentially new regulations. In addition, the study design proved to be fit for the purpose of providing future certified reference materials, which surpass current analyte matrix combinations and exceed the typical scope of the regulatory framework.