The Development and Validation of a Lateral Flow Device for the Rapid Detection of Total Milk Proteins in CIP and Environmental Samples

Introduction: Allergy to bovine milk proteins represents one of the most common food-based allergies and cow’s milk is one of the most common ingredients in food and nutritional supplements.  Because of the widespread use of milk and milk proteins in food production, there is a need to screen for the presence of milk proteins in food handling areas and equipment.  Reveal™3D Total Milk is a rapid lateral flow device which provides rapid and accurate information regarding presence of milk proteins.

Purpose: The purpose of this study was to develop and validate a new device for detection of milk proteins in clean-in-place (CIP) solutions and environmental samples and to determine the limit of detection of this assay. 

Methods: A rapid lateral flow device for detection of total milk protein (including casein and whey) has been developed.  This is a sandwich-based assay utilizing 1 antibody for capture and a 2^nd antibody linked to a colored particle for detection.  An extraction process has been developed to allow for detection of milk protein in various sample types including CIP and environmental samples.

Results: The device is accurate, rapid and simple and does not require special tools or extensive training and yields results in less than ten minutes from sample collection. The lower limit of detection is 5 ppm in CIP solutions and 20 μg/100 cm² for total milk proteins.  This lateral flow device has a third line of detection, which is included to signal the presence of a grossly contaminated solution or surface and eliminate potential for false negative results in these samples.

Significance: This rapid lateral flow device provides rapid and accurate indication of the presence of milk proteins in CIP and environmental samples while providing confidence that highly contaminated samples are detected and not read as a false negative.