LATERAL-FLOW IMMUNO-CHROMATOGRAPHIC ASSAY DEVICES
First Claim
1. A device, comprising:
- a migration membrane, having a test line configured for loading onto the test line of one or a plurality of capture antibodies having specific binding affinity for an assay target, the migration membrane being configured for allowing lateral flow of blood plasma or serum across the migration membrane to the test line;
a conjugate pad on the migration membrane, being configured for loading onto the conjugate pad of one or a plurality of detection antibodies having specific binding affinity for an assay target;
a plasma separation membrane on the conjugate pad, the plasma separation membrane being configured for allowing passage of blood plasma or serum through the plasma separation membrane and for trapping erythrocytes; and
a pre-filter on the plasma separation membrane, the pre-filter being configured for loading of an assay sample including erythrocytes and either or both of blood plasma and blood serum onto the pre-filter, the pre-filter being configured for allowing passage of blood plasma or serum through the pre-filter and configured for causing lateral flow of blood plasma or serum within the pre-filter.
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Abstract
Device including migration membrane, conjugate pad on migration membrane, plasma separation membrane on conjugate pad, pre-filter on plasma separation membrane. Migration membrane has test line configured for loading one or plurality of capture antibodies having specific binding affinity for assay target. Migration membrane configured for allowing lateral flow of blood plasma or serum across migration membrane to test line. Conjugate pad configured for loading one or plurality of detection antibodies having specific binding affinity for assay target. Plasma separation membrane configured for allowing passage of blood plasma or serum and trapping erythrocytes. Pre-filter configured for loading assay sample including erythrocytes and either or both blood plasma and blood serum. Pre-filter configured for allowing passage of blood plasma or serum through pre-filter and causing lateral flow of blood plasma or serum within pre-filter. Method includes providing device and carrying out diagnostic assay cycle.
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Citations
36 Claims
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1. A device, comprising:
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a migration membrane, having a test line configured for loading onto the test line of one or a plurality of capture antibodies having specific binding affinity for an assay target, the migration membrane being configured for allowing lateral flow of blood plasma or serum across the migration membrane to the test line; a conjugate pad on the migration membrane, being configured for loading onto the conjugate pad of one or a plurality of detection antibodies having specific binding affinity for an assay target; a plasma separation membrane on the conjugate pad, the plasma separation membrane being configured for allowing passage of blood plasma or serum through the plasma separation membrane and for trapping erythrocytes; and a pre-filter on the plasma separation membrane, the pre-filter being configured for loading of an assay sample including erythrocytes and either or both of blood plasma and blood serum onto the pre-filter, the pre-filter being configured for allowing passage of blood plasma or serum through the pre-filter and configured for causing lateral flow of blood plasma or serum within the pre-filter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method, comprising:
providing a lateral-flow immuno-chromatographic assay device including a migration membrane, a conjugate pad being on the migration membrane, a plasma separation membrane being on the conjugate pad, and a pre-filter being on the plasma separation membrane;
wherein the conjugate pad is loaded with one or a plurality of detection antibodies having specific binding affinity for an assay target; and
wherein the migration membrane has a test line loaded with one or a plurality of capture antibodies having specific binding affinity for the assay target; and
carrying out a diagnostic assay cycle, including;loading an assay sample including erythrocytes and either or both of blood plasma and blood serum onto the pre-filter; causing blood plasma or serum to laterally flow within the pre-filter and allowing blood plasma or serum to pass through the pre-filter to the plasma separation membrane; causing erythrocytes to be trapped in the plasma separation membrane and allowing blood plasma or serum to pass through the plasma separation membrane to the conjugate pad; and allowing blood plasma or serum to pass through the conjugate pad onto the migration membrane and allowing blood plasma or serum to laterally flow across the migration membrane to the test line. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
Specification