Diagnostic detection device and method
AssigneeCarter-Wallace, Inc.
InventorsAlbert Nazareth, Mary Beth Boyle, Yea-Shun Cheng
Life of this patent
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Abstract
The invention provides an improved test cell for detecting the presence of an analyte in a liquid sample. The device has an elongate casing defining a liquid sample inlet, a reservoir volume, a test volume, and a window through the casing at the test volume. Disposed within the cell is a sample absorbent, a novel biphasic substrate and a reservoir, together capable of transporting an aqueous solution within the casing along a flow path extending from the sample inlet through the test volume and into the reservoir volume. The invention further comprises a method for detecting the presence of an analyte in a liquid sample using the device and a biphasic chromatographic material for carrying out the method.
Claims23
A device for determining the presence in a liquid sample of an analyte wherein liquid sample deposited on a proximal end of said device travels downstream along a liquid path to a distal end of said device, said device comprising:
- a. a biphasic substrate comprising (1) a release medium of a first material and, in fluid communication and downstream thereof, (2) a capture medium of a microporous, second, different material,
- wherein located at said release medium of said biphasic substrate for release therefrom is
- (i) a labeled conjugate comprising a binding member reactive with a first epitope of said analyte labeled with a detectable marker, and
- (ii) a capturable component reactive with a second epitope of said analyte, such that if said analyte is present in said sample, said analyte produces a complex comprising said labeled conjugate, said analyte and said capturable component, and
- located at said capture medium of said biphasic substrate is
- a capture site for capturing said complex, said capture site having immobilized thereon a capture component having a binding affinity for said capturable component;
- and
- b. a casing enclosing said biphasic substrate, said casing defining a sample inlet in fluid communication with said release medium of said biphasic substrate and a detection opening for viewing said capture site.
A device for determining the presence in a liquid sample of an analyte wherein liquid sample deposited on a proximal end of said device travels downstream along a liquid path to a distal end of said device, said device comprising:
- a. a biphasic substrate comprising (1) a release medium of a first material and in fluid communication and downstream thereof, (2) a capture medium of a second, different material of nylon or nitrocellulose, wherein said release medium and said capture medium are both immobilized on a single backing support,
- wherein located at said release medium of said biphasic substrate for release therefrom is
- (i) a labeled conjugate comprising a first antibody that binds a first epitope of said analyte labeled with a detectable marker, and
- (ii) a capturable component comprising a biotinylated second antibody that binds a second, different epitope of said analyte, such that if said analyte is present in said sample, said analyte produces a complex comprising said labeled conjugate, said analyte and said capturable component, and
- located at said capture medium of said biphasic substrate is
- a capture site for capturing said complex, said capture site having a capture component immobilized thereon for binding said capturable component;
- and
- b. a casing enclosing said biphasic substrate, said casing defining a sample inlet in fluid communication with said release medium of said biphasic substrate and a detection opening for viewing said capture site.
Dependencies are inferred from the claim text.