Patent ID: 7803633

Claim:
A method of conducting and screening an agglutination test to identify the presence of an analyte in a sample, said test producing agglutination areas and background areas, said method comprising the steps of: mixing said sample with one or more agglutination reactants to form a sample and reactant mixture; flowing said sample and reactant mixture through a channel where an agglutination reaction or an agglutination pre-processing reaction occurs; receiving the mixture in a reaction chamber where the agglutination reaction occurs or is completed; illuminating said reaction chamber; detecting the intensity of light which is reflected from said agglutination areas and said background areas of said reaction chamber; representing the intensity of said detected light in a digitized data array; determining a threshold intensity by analyzing the distribution of pixel intensities across said data array to determine the intensity below or above which a pre-set percentage of pixels lie; thresholding said data array using the threshold intensity to distinguish between said background areas and said agglutination areas; identifying said agglutination areas; estimating the number of said agglutination areas; determining whether said agglutination areas exhibit a statistically significant result; and outputting said results.