Validation of the GlutenTox® ELISA Rapid G12 Test Kit for Determination of Gluten in Select Non-Heat-Processed Matrixes and Heat-Processed Matrixes: AOAC Performance Tested MethodSM 042301.

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL Journal of AOAC International Pub Date : 2023-11-02 DOI:10.1093/jaoacint/qsad081
Carlos Galera, Claudia Salagre, Ana López
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Abstract

Background: The GlutenTox® ELISA Rapid G12 test kit is a quantitative method designed for the determination of the immunotoxic fraction of gluten in food samples.

Objective: To obtain AOAC Performance-Tested MethodsSM certification for the method for the detection and quantification of gluten from wheat, barley, and rye flours in select foods (non-heat-processed) and incurred (heat-processed) matrixes.

Methods: The method was evaluated following the Guidelines for Validation of Quantitative Gluten Methods, with Specific Examples for ELISA Assays. The validation study was conducted at Hygiena Diagnóstica España using five food matrixes (soy flour, corn bread, seasoning mix, rolled oats, and evaporated milk) artificially contaminated with gluten from wheat, barley, or rye flour at different concentrations: 0, 5, 10, and 20 mg/kg. For each matrix and gluten contamination level, five or six individually extracted test portions were analyzed. A second bread matrix was prepared by baking a gluten-free bread mix spiked at 0, 20, and 30 mg/kg gluten from wheat, barley, or rye flour for incurred matrix testing. Ten individually extracted test portions were tested for each incurred bread and contamination level of gluten.

Results: The method met the AOAC performance requirements for detection and quantification of wheat gluten in the selected food matrixes, incurred bread sample, and spike levels of wheat gluten, showing an acceptable recovery. When tested with barley and rye flours, most of the results showed acceptable recoveries or a slight overestimation, depending on the matrix and gluten concentration. Method developer and independent laboratory results were comparable.

Conclusions: The validation study demonstrated that the test kit is a reliable, accurate, quick, and easy-to-use method for the detection and quantification of gluten concentration in food and incurred matrixes from wheat, barley, and rye flours.

Highlights: Most reagents provided in the kit are at ready-to-use concentrations.

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gltentox®ELISA快速G12检测试剂盒用于非热处理基质和热处理基质中麸质含量的验证:AOAC性能测试方法sm 042301
背景:谷蛋白毒素®ELISA快速G12检测试剂盒是一种用于测定食品样品中谷蛋白免疫毒性部分的定量方法。目的:获得AOAC性能测试方法SM认证,用于检测和定量选定食品(非热加工)和加工(热加工)基质中小麦、大麦和黑麦面粉中的面筋。方法:根据《定量谷蛋白方法验证指南》对该方法进行评估,并提供ELISA检测的具体实例。验证研究是在西班牙卫生研究所进行的,使用了五种食品基质(大豆粉、玉米面包、调味混合物、燕麦卷和炼乳),这些基质被不同浓度的小麦、大麦或黑麦面粉中的谷蛋白人工污染:0、5、10和20 mg/kg。对于每个基质和面筋污染水平,分析五到六个单独提取的测试部分。通过烘焙掺入0、20和30的无麸质面包混合物来制备第二面包基质 mg/kg来自小麦、大麦或黑麦面粉的面筋,用于进行基质测试。针对每个产生的面包和面筋的污染水平,测试了10份单独提取的测试份。结果:该方法满足AOAC对所选食品基质、面包样品中小麦面筋含量和小麦面筋峰值水平的检测和定量性能要求,显示出可接受的回收率。当用大麦和黑麦面粉进行测试时,根据基质和面筋浓度的不同,大多数结果显示出可接受的回收率或略有高估。方法开发人员和独立实验室的结果具有可比性。结论:验证研究表明,该检测试剂盒是一种可靠、准确、快速、易于使用的方法,可用于检测和定量小麦、大麦和黑麦面粉中食品和基质中的面筋浓度。亮点:试剂盒中提供的大多数试剂都是现成的浓度。
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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