Diagnostic devices and apparatus for the controlled movement of reagents without membranes
First Claim
1. An assay device comprising:
- i. a sample addition reservoir positioned so that one side of said sample addition reservoir is adjacent to a sample reaction barrier (ii);
ii. a sample reaction barrier between said sample addition reservoir and said reaction chamber, said barrier having a capillarity greater than the capillarity of said reaction chamber, whereby absent an externally applied force, fluid flows from the sample reaction barrier to the reaction chamber pursuant to capillary force;
iii. a reaction chamber adapted for receiving fluid from said sample reaction barrier, said chamber comprising a wall which comprises at least two fingers;
iv. a time gate positioned immediately adjacent to the reaction chamber to receive fluid into said diagnostic element;
v. a diagnostic element capable of immobilizing at least one conjugate in at least one zone; and
.vi. a used reagent reservoir disposed a capillary space away from said diagnostic element, so that fluid flow is directed into said capillary space.
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Accused Products
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
50 Claims
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1. An assay device comprising:
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i. a sample addition reservoir positioned so that one side of said sample addition reservoir is adjacent to a sample reaction barrier (ii); ii. a sample reaction barrier between said sample addition reservoir and said reaction chamber, said barrier having a capillarity greater than the capillarity of said reaction chamber, whereby absent an externally applied force, fluid flows from the sample reaction barrier to the reaction chamber pursuant to capillary force; iii. a reaction chamber adapted for receiving fluid from said sample reaction barrier, said chamber comprising a wall which comprises at least two fingers; iv. a time gate positioned immediately adjacent to the reaction chamber to receive fluid into said diagnostic element; v. a diagnostic element capable of immobilizing at least one conjugate in at least one zone; and
.vi. a used reagent reservoir disposed a capillary space away from said diagnostic element, so that fluid flow is directed into said capillary space. - View Dependent Claims (2, 3)
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4. An assay device comprising:
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i. a sample addition reservoir; ii. a reaction chamber; iii. a sample reaction barrier between said sample addition reservoir and said reaction chamber, said sample reaction barrier having a greater capillarity than said reaction chamber, wherein said reaction chamber is adapted to receive fluid flow from said sample reaction barrier; iv. a wall perpendicular or substantially perpendicular to fluid flow in said sample reaction barrier, said wall located at the interface between said sample reaction barrier and said reaction chamber, said wall comprising grooves perpendicular or substantially perpendicular to fluid flow in said sample reaction barrier, said grooves having widths of between 0.5 mm to 2 mm wide and 0.1 mm to 1.5 mm in depth, whereby absent an externally applied force, fluid flows from the sample reaction barrier to the reaction chamber pursuant to capillary force; iv. a time gate for delaying fluid flow from said reaction chamber to a separation element (v), said time gate located between said reaction chamber and said separation element, said time gate comprising at least one hydrophobic surface which is capable of binding at least one component present in said fluid; and
whereby the delay of fluid flow is related to the rate of binding of the component to said hydrophobic surface whereby binding of the component to said hydrophobic surface changes said hydrophobic surface into a hydrophilic surface whereby fluid can flow into said separation element;v. a separation element capable of entrapping, or removing by binding at least one component from said fluid; vi. a time gate for delaying fluid flow from said separation element to a diagnostic element (vii) so as to maximize desired binding interactions in said diagnostic element, said time gate located between said separation element and said diagnostic element, said time gate comprising at least one hydrophobic surface which is capable of binding at least one component present in said fluid; and
whereby the delay of fluid flow is related to the rate of binding the component to said hydrophobic surface whereby binding of the component to said hydrophobic surface changes said hydrophobic surface into a hydrophilic surface whereby fluid can flow into said diagnostic element (vii);vii. a diagnostic element capable of immobilizing at least one conjugate in at least one zone; and
,viii. a used reagent reservoir. - View Dependent Claims (5, 6)
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7. Diagnostic assay device comprising:
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i. a sample addition reservoir; ii. a sample reaction barrier between said sample addition reservoir and a reaction chamber (iii), said sample reaction barrier comprising a first capillary; iii. the reaction chamber, said reaction chamber comprising a second capillary, said second capillary adapted to receive fluid flow from said first capillary, said first capillary having a greater capillarity than said second capillary; iv. a wall perpendicular or substantially perpendicular to fluid flow in said first capillary, said wall located at the interface between said first capillary and said second capillary, said wall comprising grooves substantially perpendicular to fluid flow in said first capillary, said grooves having widths of between 0.5 mm to 2 mm wide and 0.1 mm to 1.5 mm in depth, whereby absent an externally applied force, fluid flows from the sample reaction barrier to a reaction chamber pursuant to capillary force; v. a membrane comprising a time gate, said time gate for delaying fluid flow from said membrane to a diagnostic element (vi), said time gate immobilized in said membrane, with said time gate located next to, or a capillary distance from, said diagnostic element, said time gate comprising at least one hydrophobic surface which is capable of binding at least one component present in said fluid; and
whereby the delay of fluid flow is related to the rate of binding the component to said hydrophobic surface whereby binding of the component to said hydrophobic surface changes said hydrophobic surface into a hydrophilic surface whereby fluid can flow into said diagnostic element;vi. a diagnostic element capable of immobilizing at least one conjugate in at least one zone; and
,vii. a used reagent reservoir.
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8. An assay device comprising:
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i. a sample addition reservoir; ii. a reaction chamber; iii. a sample reaction barrier between said sample addition reservoir and said reaction chamber, said sample reaction barrier having a greater capillarity than said reaction chamber, wherein said reaction chamber is adapted to receive fluid flow from said sample reaction barrier; iv. a wall perpendicular or substantially perpendicular to a fluid flow direction in said sample reaction barrier, said wall located at the interface between said sample reaction barrier and said reaction chamber, said wall comprising grooves perpendicular or substantially perpendicular to the fluid flow direction in said sample reaction barrier, said grooves having widths of between 0.5 mm to 2 mm wide and 0.1 mm to 1.5 mm in depth, whereby absent an externally applied force, fluid flows from the sample reaction barrier to a reaction chamber pursuant to capillary force; and
.v. a diagnostic element capable of immobilizing at least one conjugate in at least one zone, said diagnostic element fluidly connected to said reaction chamber. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16)
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17. An assay device for detecting at least one target ligand in a fluid sample, the device comprising:
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a first capillary region and a second capillary region, said first capillary region having a greater capillarity than said second capillary region; and
,a wall perpendicular or substantially perpendicular to a fluid flow direction in said first capillary region, said wall located at an interface between said first capillary region and said second capillary region, said wall comprising grooves perpendicular or substantially perpendicular to the fluid flow direction in said first capillary region, wherein said grooves are between 0.5 mm to 2 mm wide and 0.1 mm to 1.5 mm deep, whereby absent an externally applied force, fluid flows from the first capillary region to the second capillary region pursuant to capillary force.
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18. An assay device for detecting at least one target ligand in a fluid sample, said assay device comprising:
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a. a sample addition reservoir; b. a time gate for delaying fluid flow; c. a diagnostic element;
wherein said assay device is configured and arranged such that said fluid sample flows from said sample addition reservoir to said time gate to said diagnostic element. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
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Specification