Immuno-gold lateral flow assay
First Claim
1. A chromatographic specific binding assay strip device, comprising:
- a laminate strip having a first side and a second side;
a sample receiving pad, a fibrous reservoir pad disposed on said first side of said laminate strip; and
a fibrous detection pad disposed between said fibrous sample pad, wherein said fibrous reservoir pad is disposed at the distal end of said device facilitating unidirectional capillary migration through the detection pad or membrane;
a fibrous conjugate pad disposed on said second side of said laminate;
wherein said laminate strip is configured to fold back at a hinge point, such that laminate strip and conjugate pad on the second side are positioned on top of the sample receiving pad;
wherein said laminating strip separates the conjugate pad from the sample pad such that the flow path of liquid migration is slowed.
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Accused Products
Abstract
A chromatographic lateral-flow assay system for rapid, high sensitivity method of detecting low levels of ligands in body fluids, with few false positives and few false negatives. The lateral-flow assay may have a membrane strip in ribbon form, which increases detection on the order of 2 to 10 fold over the conventional chromatographic specific binding assay techniques by placing a dried or lyophilized conjugate in colloidal spheres opposite side of the lateral flow membrane strip. A chromatographic specific binding assay strip device, comprising: a laminate strip having a first side and an second side; a conjugate pad or membrane disposed on said first side of said laminate; a hinge region connecting sample receiving pad or membrane strip and reservoir pad or membrane disposed on said second side of said laminate; wherein said laminating material isolates the conjugate pad from the sample pad such as to slow the fluid path into the fibrous sample pad, and a detection pad or membrane strip disposed between the sample pad or membrane and the reservoir pad or membrane on said first side of said laminate. The more complete mixing permitted by this temporary obstruction provides an important feature of the invention that gives this 2-step test its superior performance. The assay system comprises a housing device, such as a test tube or cassettes to facilitate the mixing of a sample solution with the dried or lyophilized conjugate, and kits.
43 Citations
20 Claims
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1. A chromatographic specific binding assay strip device, comprising:
a laminate strip having a first side and a second side;
a sample receiving pad, a fibrous reservoir pad disposed on said first side of said laminate strip; and
a fibrous detection pad disposed between said fibrous sample pad, wherein said fibrous reservoir pad is disposed at the distal end of said device facilitating unidirectional capillary migration through the detection pad or membrane;
a fibrous conjugate pad disposed on said second side of said laminate;
wherein said laminate strip is configured to fold back at a hinge point, such that laminate strip and conjugate pad on the second side are positioned on top of the sample receiving pad;
wherein said laminating strip separates the conjugate pad from the sample pad such that the flow path of liquid migration is slowed. - View Dependent Claims (2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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3. A chromatographic specific binding assay strip device, comprising:
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two laminate strips;
a sample receiving pad, a fibrous reservoir pad disposed on said first laminate strip; and
a fibrous detection pad disposed between said fibrous sample pad, wherein said fibrous reservoir pad is disposed at the distal end of said device facilitating unidirectional capillary migration through the detection pad or membrane;
a fibrous conjugate pad disposed on said second laminate strip;
wherein said conjugate pad on the second laminate strip is positioned on top of the sample receiving pad;
wherein said second laminating strip separates the conjugate pad from the sample pad such that the flow path of liquid migration is slowed. - View Dependent Claims (4)
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Specification