Evaluation of Commercial Milk-Specific Lateral Flow Devices

Abstract

ABSTRACT The requirement for validation of allergen cleaning processes is increasing. The use of lateral flow devices (LFDs) to identify allergens has rapidly expanded, but the best practices for use of these devices are still developing. The goal of this study was to compare commercially available milk-specific LFDs and a general protein identification method. Five milk proteins and seven milk-derived ingredients were tested at several concentrations with eight milk-specific LFDs and a general protein identification kit. Nonfat dry milk (NFDM) was prepared at 100 to 10,000 ppm of milk protein and analyzed by the LFDs to determine the concentration at which a false-negative result (overload concentration or hook effect) was obtained. NFDM was also prepared in 0.025 M phosphate-buffered saline (pH 7.4, 0.85% NaCl) and applied to stainless steel panels (100, 30, 10, or 3 μg of NFDM protein) with various drying methods and sampled with various swab methods to determine the level of detectability. Several total milk LFD kits did not detect whey proteins or whey-derived ingredients. The overload concentration of the various kits ranged from 100 to 10,000 ppm of milk protein. The small dynamic range observed for some kits would necessitate multiple dilutions of a sample to ensure that the result would fall within the range of detection. For swab sampling of stainless steel for LFD analysis, milk protein residues from surfaces onto which the residues were dried with high heat were more difficult to detect than were residues dried with low heat. No differences in sensitivity were observed as a result of moistening the residue or the swab before sampling. These results highlight the importance of understanding the detection capabilities of LFDs as indicated by the variability in the performance of the milk-specific LFDs tested.