Diagnostic devices and apparatus for the controlled movement of reagents without membranes
First Claim
1. An assay device for determining the presence or amount of a plurality of different target ligands in a sample, the device comprising:
- a diagnostic element comprising a capillary space through which said sample flows, said capillary space comprising (i) a non-absorbent surface, and (ii) a plurality of discrete capture zones on said nonabsorbent surface, each discrete capture zone comprising a capture element that binds one target ligand in said plurality of different target ligands, wherein said nonabsorbent surface comprises a width dimension substantially perpendicular to the direction of fluid flow through the capillary space, and wherein each said discrete capture zone spans said width dimension.
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Abstract
The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.
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Citations
37 Claims
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1. An assay device for determining the presence or amount of a plurality of different target ligands in a sample, the device comprising:
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a diagnostic element comprising a capillary space through which said sample flows, said capillary space comprising (i) a non-absorbent surface, and (ii) a plurality of discrete capture zones on said nonabsorbent surface, each discrete capture zone comprising a capture element that binds one target ligand in said plurality of different target ligands, wherein said nonabsorbent surface comprises a width dimension substantially perpendicular to the direction of fluid flow through the capillary space, and wherein each said discrete capture zone spans said width dimension. - 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, 24)
contacting the diagnostic element of claim 1 with (i) a sample, and (ii) a labeled reagent that binds to said plurality of target ligands, whereby said sample and said labeled reagent flow through said capillary space for capture of each said different target ligand at its corresponding capture zone; and generating a plurality of detectable signals from label bound to each different target ligand at its corresponding capture zone, whereby said signals are related to the presence or amount of said plurality of different target ligands in said sample.
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16. The method of claim 15, wherein said diagnostic element comprises at least 50 said discrete capture zones, corresponding to at least 50 different target ligands.
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17. The method of claim 15, wherein said capture element is selected from the group consisting of an antibody or binding fragment thereof, a nucleotide sequence, an enzyme, a chelator, and a biosensor.
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18. The method of claim 15, wherein said discrete capture zones comprise particles immobilized thereon, wherein said particles comprise said capture element immobilized thereon.
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19. The method of claim 15, wherein said labeled reagent is a fluorescently labeled reagent.
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20. A method for determining the presence or amount of a plurality of different target ligands in a sample, the method comprising:
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contacting the diagnostic element of claim 1 with (i) a sample, and (ii) a plurality of ligand analogue conjugates, each ligand analogue conjugate corresponding to one of said plurality of different target ligands, whereby said sample and said plurality of ligand analogue conjugates flow through said capillary space, whereby each different target ligand competes with its corresponding ligand analogue conjugate for capture at its corresponding capture zone; and generating a plurality of detectable signals from ligand analogue conjugate bound at its corresponding capture zone, whereby said signals are related to the presence or amount of said plurality of different target ligands in said sample.
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21. The method of claim 20, wherein said diagnostic element comprises at least 50 said discrete capture zones, corresponding to at least 50 different target ligands.
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22. The method of claim 20, wherein said capture element is selected from the group consisting of an antibody or binding fragment thereof, a nucleotide sequence, an enzyme, a chelator, and a biosensor.
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23. The method of claim 20, wherein said discrete capture zones comprise particles immobilized thereon, wherein said particles comprise said capture element immobilized thereon.
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24. The method of claim 20, wherein said ligand analogue conjugate is a fluorescently labeled ligand analogue conjugate.
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25. An assay device for determining the presence or amount of a plurality of different target ligands in a sample, the device comprising:
a diagnostic element comprising a capillary space through which said sample flows, said capillary space comprising (i) a non-absorbent hydrophilic surface region and (ii) a plurality of discrete capture zones on said nonabsorbent hydrophilic surface region, each discrete capture zone comprising a capture element that binds one target ligand in said plurality of different target ligands, wherein said nonabsorbent hydrophilic surface region comprises a width dimension substantially perpendicular to the direction of fluid flow through the capillary space, and wherein each said discrete capture zone spans said width dimension. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
Specification