US 4,786,471 A · Heterogeneous immunoassay method and assembly

Abstract

A method and assembly 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 and a second chamber separated by a separation means 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 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 a 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.

Claims23

Dependent claims

A hand-held assembly for the detection and determination of at least one ligand in a sample suspected of containing such ligand, the assembly comprising:

a vessel having a first chamber for receiving a sample suspected of containing the ligand, which first chamber includes an admixture of a binding partner for such ligand and a labeled component 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;
a second vessel having a second chamber separated from the first chamber by a separation means for permitting the passage therethrough of free labeled component of a relatively small size while preventing the passage therethrough of a complex formed from ligand, binding partner and labeled component of a relatively larger size than the free labeled component, when a pressure differential is created across such separation means;
means for creating a pressure differential across the separation means to separate the free labeled component from the complex and collect the free labeled component in the second chamber;
and
label detecting reagents in the second chamber.

2 more elements

A kit for the detection and determination of at least one ligand in a sample suspected of containing such ligand, the kit comprising:

a first vessel having a first chamber for receiving a sample suspected of containing the ligand, which first chamber includes an admixture of a binding partner for such ligand and a labeled component 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;
a separation means provided in the first vessel for permitting the passage therethrough of free labeled component of a relatively small size while preventing the passage therethrough of a complex formed from ligand, binding partner and labeled component of a relatively larger size than the free labeled component when a pressure differential is created across such separation means;
a second vessel having a second chamber having a reduced pressure therein;
label detecting reagent in the second chamber of the second vessel;
a puncturable top enclosing the second chamber of the second vessel;
an outlet port on the first vessel;
a needle hub attached to the outlet port of the first vessel;
and a needle cannula attached to the needle hub, which needle cannula is capable of piercing the top on the second vessel to expose the separation medium to the reduced pressure in the second vessel and create a pressure differential across the separation means for separating the free labeled component from the complex, which free labeled component flows through the needle cannula and is collected in the second chamber of the second vessel.

5 more elements

Dependencies are inferred from the claim text.

Heterogeneous immunoassay method and assembly

Life of this patent

Heterogeneous immunoassay method and assembly

Life of this patent

Abstract

Claims23