Improved heterogeneous immunoassay method and assembly.

摘要

A method and assembly (10) provided for the detection and determination of at least one ligand in a sample suspected of containing the ligand. The method includes providing in a hand-held assembly having a first chamber (14) and a second chamber (26) separated by a separation means (18) which permits the passage therethrough of materials of a relatively small size while preventing the passage therethrough of materials of a relatively larger size; a suspension (16) in the first chamber of an admixture of a binding partner for the ligand and a labeled component. The labeled component is selected from the group consisting of binding partner, compound which can bind to the binding partner, compound which can bind to the reaction product of the ligand and binding partner, and compound which can bind to the ligand. The sample suspected of containing the ligand is introduced to the first chamber. The mixture is incubated for a time sufficient to form a reaction mixture containing free labeled component and a complex of the labeled component, binding partner and ligand. The free labeled component is separated from the complex by creating pressure differential across the separation medium whereby the relatively larger size complex remains in the first chamber while the relatively smaller size free labeled component passes to the second chamber. The presence of either the labeled component present in the complex in the first chamber or the free labeled component in the second chamber is determined. The determination of such labeled component in either chamber provides a measure of the presence and quantity of the ligand in the sample.