Patent ID: 9395365
Filing Date: 2016-07-19
CPC Classification: C12Q,G01N,Y02A

Claim Text:
1. A method for performing a target analyte assay of a thin film monolayer sample of anticoagulated viable whole blood to determine a presence or absence of a blood donor's recent exposure or active infection with a defined pathogenic agent, wherein the target analyte is the presence or absence of specific phagocytosis and/or binding of particles coated with a particular antigen or antigens by white blood cells contained in said blood sample, said method comprising the steps of: mixing and incubating said blood sample with first detectable particles which are coated with an antigen that is specific to said target analyte, and with second detectable particles which are not coated with said antigen in said incubated mixture, and which second particles are distinguishable from the first particles on the basis of color or fluorescence, or both, so as to create an incubated mixture of said blood sample, said first particles, and said second particles, wherein the first and second particles are distinguishable from one another within the mixture; providing a sample chamber having a through plane thickness of between 3 and 25 μm; filling said chamber with said blood sample mixture; optically imaging said blood sample mixture within said chamber using an electronic photometric microscope device to determine an amount of any of said first particles which have been phagocytosed by individual white blood cells, and to determine an amount of any of said second particles which have been have been phagocytosed by individual white blood cells; and determining the presence or absence of the blood donor's recent exposure or active infection with the defined pathogenic agent, based on the determined amount of said first particles phagocytosed by individual white blood cells, and the determined amount of said second particles phagocytosed by individual white blood cells.