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Validation of the OnSite® Gluten Test Kit for Detection of Gluten in Select Foods and Environmental Surfaces: AOAC
Meiting Wu1, Lora Benoit1, Cesar Nadala1
1IEH Laboratories & Consulting Group, 15300 Bothell Way NE, Lake Forest Park, WA 98155, USA.
Background:
The OnSite® Gluten Test Kit is a qualitative immunochromatographic assay designed for the detection of gluten in foods and on environmental surfaces.
Objective:
To validate the performance of the OnSite Gluten Test Kit in rice flour, oat flour, spice mix, and bread, and on stainless steel surfaces.
Methods:
The kit was assessed for cross-reactivity, interference, detection capability of spiked and incurred gluten, recovery from stainless steel surfaces, lot-to-lot consistency, robustness, and stability.
Results:
Testing revealed no cross-reactivity or interference from a panel of gluten-free (GF) food items, or susceptibility to high analyte concentration. Analysis of selected spiked or incurred test materials at various estimated concentrations of gluten supported claimed detection capabilities (CDC) ranging from 5 to 20 mg/kg gluten depending on the aliquot volume and food matrix. The method detected wheat gluten present on stainless steel at a contamination level of 11 µg gluten/100 cm2 (probability of detection [POD] 0.95, confidence interval [CI] 0.76-1.00). Testing results also indicated consistency, robustness, and kit stability. Independent laboratory testing of select food matrixes supported the findings of the candidate laboratory.
Conclusion:
The performance of the OnSite Gluten Test Kit was validated on gluten spiked or incurred into rice flour, oat flour, spice mix, and bread, and on stainless steel surfaces.
Highlights:
The OnSite Gluten Test Kit offers an easy-to-use assay method to detect gluten in select foods and on stainless steel surfaces. The testing format affords the user flexibility in their choice of gluten detection thresholds.
