Quality Department, Hygiena Diagnóstica España, S.L.U, Calle Cañada Real 31-35, P.I. Parque Plata, Camas (Sevilla), 41900, España.
J AOAC Int. 2023 Nov 2;106(6):1478-1504. doi: 10.1093/jaoacint/qsad081.
The GlutenTox® ELISA Rapid G12 test kit is a quantitative method designed for the determination of the immunotoxic fraction of gluten in food samples.
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.
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.
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.
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.
Most reagents provided in the kit are at ready-to-use concentrations.
GlutenTox® ELISA Rapid G12 检测试剂盒是一种定量方法，旨在测定食品样品中面筋的免疫毒性部分。
获得 AOAC 经过性能测试的方法 SM 认证，用于检测和定量来自小麦、大麦和黑麦面粉的面筋，适用于选定的食品（未经热处理）和加工（热处理）基质。
该方法是按照定量面筋方法验证指南进行评估的，其中包括 ELISA 测定的具体示例。验证研究在 Hygiena Diagnóstica España 进行，使用五种食品基质（大豆粉、玉米面包、调味料混合物、燕麦片和蒸发牛奶），用不同浓度的来自小麦、大麦或黑麦面粉的面筋进行人工污染：0、5、10 和 20mg/kg。对于每个基质和面筋污染水平，分析了五个或六个单独提取的测试部分。第二个面包基质是通过烘烤一种无麸质面包混合物制备的，该混合物在 0、20 和 30mg/kg 来自小麦、大麦或黑麦面粉的面筋时受到污染，用于进行加工基质测试。对于每种加工面包和面筋污染水平，测试了十个单独提取的测试部分。
该方法满足了在选定食品基质、加工面包样本和小麦面筋添加水平下检测和定量小麦面筋的 AOAC 性能要求，回收率可接受。当用大麦和黑麦面粉进行测试时，大多数结果显示可接受的回收率或轻微的高估，这取决于基质和面筋浓度。方法开发者和独立实验室的结果具有可比性。
验证研究表明，该试剂盒是一种可靠、准确、快速且易于使用的方法，可用于检测和定量来自小麦、大麦和黑麦面粉的食品和加工基质中的面筋浓度。
试剂盒中提供的大多数试剂均为即用型浓度。
