Diagnostic detection device and method
First Claim
1. A method for determining the presence of an analyte in a liquid sample, the method comprising:
- a. providing 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 the release medium of the biphasic substrate for release therefrom is (i) a labeled conjugate comprising a binding member reactive with a first epitope of the analyte labeled with a detectable marker, and (ii) a capturable component reactive with a second epitope of the analyte, such that if the analyte is present in the sample, the analyte produces a complex comprising the labeled conjugate, the analyte and the capturable component, and located at the capture medium of the biphasic substrate is a capture site for capturing the complex, the capture site having immobilized thereon a capture component having a binding affinity for the capturable component;
b. contacting the biphasic substrate with the liquid sample such that the liquid sample travels downstream from the release medium to the capture site; and
c. determining whether the analyte is present in the sample by observing the presence of the detectable marker at the capture site.
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Accused Products
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.
182 Citations
25 Claims
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1. A method for determining the presence of an analyte in a liquid sample, the method comprising:
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a. providing 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 the release medium of the biphasic substrate for release therefrom is (i) a labeled conjugate comprising a binding member reactive with a first epitope of the analyte labeled with a detectable marker, and (ii) a capturable component reactive with a second epitope of the analyte, such that if the analyte is present in the sample, the analyte produces a complex comprising the labeled conjugate, the analyte and the capturable component, and located at the capture medium of the biphasic substrate is a capture site for capturing the complex, the capture site having immobilized thereon a capture component having a binding affinity for the capturable component;
b. contacting the biphasic substrate with the liquid sample such that the liquid sample travels downstream from the release medium to the capture site; and
c. determining whether the analyte is present in the sample by observing the presence of the detectable marker at the capture site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method for determining the presence of an analyte in a liquid sample, the method comprising:
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a. providing 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 the release medium and the capture medium are both immobilized on a single backing support, wherein located at the release medium of the biphasic substrate for release therefrom is (i) a labeled conjugate comprising a first antibody that binds a first epitope of the analyte labeled with a detectable marker, and (ii) a capturable component comprising a biotinylated second antibody that binds a second, different epitope of the analyte, such that if the analyte is present in the sample, the analyte produces a complex comprising the labeled conjugate, the analyte and the capturable component, and located at the capture medium of the biphasic substrate is a capture site for capturing the complex, the capture site having a capture component immobilized thereon for binding the capturable component; and
b. contacting the biphasic substrate with the liquid sample such that the liquid sample travels downstream from the release medium to the capture site; and
c. determining whether the analyte is present in the sample by observing the presence of the detectable marker at the capture site. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
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Specification