Two-site allergen immunoassay

Abstract

An allergen immunoassay method features the use of a combination of a) closely controlled 1) elevated temperatures for assay reactions, 2) low temperatures for reagents and samples, 3) times for assay steps and especially assay reaction times, 4) reagent concentrations, and 5) reagent amounts; b) the use of a fast and accurate method of sample preparation that removes dust and contaminants; c) the stabilization of samples to avoid auto- and antibody degradation and unwanted effects of sample contaminants; and d) the formation of a colored product to determine the amount of a specific allergen. This combination provides an assay that can be completed in a few hours while retaining the precision, accuracy, sensitivity and response curve of previous methods requiring much longer periods of time. The assay is especially suitable for computer control using a robotic liquid distribution system and allows for the determination of four different specific allergens in one hundred sixty samples in duplicate with standards and controls in an eight hour period with a significant reduction in the number of steps and attended technician time over previous assays.