Antigens embedded in thermoplastic

• US 6,872,576 B1
• Filed: 03/17/2000
• Issued: 03/29/2005
• Est. Priority Date: 08/12/1997
• Status: Expired due to Fees

• Current Assignee: Embedded Concepts LLC
• Original Assignee: Embedded Concepts LLC
• Inventors: McIntyre, John A.
• Primary Examiner(s): Smith, Lynette R. F.
• Assistant Examiner(s): PORTNER, VIRGINIA ALLEN
• Application Number:
  US09/528,181
• Time in Patent Office: 1,838 Days
• Field of Search: 424/422, 424/93.2, 424/426, 424/78, 424/36, 424/485, 424/81, 424/27, 530/810, 530/815, 530/817, 433/4.1, 435/178, 435/174, 435/7, 435/177, 435/4, 435/7.1, 106/213, 106/127, 525/54.1, 195/63, 128/743, 526/201, 526/221
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: Y10S 530/81 Carrier - bound or immobilized peptides or proteins and the preparation thereof, e.g. biological cell or cell fragment as carrier
• CPC Class Codes: Y10S 530/815 Carrier is a synthetic polymer
• CPC Class Codes: Y10S 530/817 Entrapped within the carrier, e.g. gel, hollow fibre
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The invention relates to an immunoassays, binding assays, solid phase substrates (12) and other devices with an antigen or antibody or ligand or receptor (11) embedded into a solid phase substrate (12). The antigen or antibody is mixed with a molten thermoplastic and formed into the solid phase substrate (12).

Claims

1. A binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding and wherein the binding agent is selected from the group consisting of lipoproteins, glycoproteins, metalloproteins, lyophilized proteins, carbohydrates, lipids, phospholipids, polynucleotides, glucosaminoglycans, platelets, erythrocytes, cells, lyophilized platelets, lyophilized platelet fragments and combinations thereof.

2. The binding agent-containing monolithic solid material according to claim 1 wherein the solid material is a plastic material.

3. The binding agent-containing monolithic solid material according to claim 1 wherein the solid material is in a form of a bead, tube or well.

4. The binding agent-containing monolithic solid material according to claim 1 wherein the solid material is a component of an affinity separation device.

5. The binding agent-containing monolithic solid material according to claim 1 wherein the solid material is a component of an immunoassay device.

6. A binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding, wherein the binding agent is selected from the group consisting of lipoproteins, glycoproteins, metalloproteins, lyophilized proteins, carbohydrates, lipids, phospholipids, polynucleotides, glucosaminoglycans, platelets, erythrocytes, cells, lyophilized platelets, lyophilized platelet fragments and combinations thereof, and wherein the binding agent-containing monolithic solid material is formed by a process comprising the steps of

mixing the binding agent with a fluid material that is to become the monolithic solid material so that the binding agent becomes evenly distributed within the fluid material to form a mixture,

forming the mixture into a desired shape and allowing the mixture to solidify to form a monolithic solid material having the desired shape and wherein the binding agent is not a participant in a reaction of solidifying the mixture.

7. A method for preparing a binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding and wherein the binding agent is selected from the group consisting of lipoproteins, glycoproteins, metalloproteins, lyophilized proteins, carbohydrates, lipids, phospholipids, polynucleotides, glucosaminoglycans, platelets, erythrocytes, cells, lyophilized platelets, lyophilized platelet fragments and combinations thereof, the method comprising the steps of:

mixing the binding agent with a fluid material that is to become the monolithic solid material so that the binding agent becomes evenly distributed within the fluid material to form a mixture,

forming the mixture into a desired shape and allowing the mixture to solidify to form a monolithic solid material having the desired shape and wherein the binding agent is not a participant in a reaction of solidifying the mixture.

8. The method according to claim 7 wherein the solid phase substrate is a plastic.

9. The method according to claim 7 wherein the plastic is a thermoplastic material which forms the fluid material when heated.

10. The method according to claim 7 wherein the fluid material contains a monomer or oligomer which forms the monolithic solid material when polymerized or cross-linked.

11. The method according to claim 10 wherein the monomer or oligomer is polymerized or crosslinked by heat or the addition of a chemical.

12. The method according to claim 7 wherein the binding agent is an antigen or hapten.

13. A binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding and wherein the binding agent is a platelet, a lyophilized platelet, or a lyophilized platelet fragment.

14. The binding agent-containing monolithic solid material according to claim 13 wherein the solid material is a plastic material.

15. The binding agent-containing monolithic solid material according to claim 13 wherein the solid material is in a form of a bead, tube or well.

16. The binding agent-containing monolithic solid material according to claim 13 wherein the solid material is a component of an affinity separation device.

17. The binding agent-containing monolithic solid material according to claim 13 wherein the solid material is a component of an immunoassay device.

18. A binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding, wherein the binding agent is a platelet, a lyophilized platelet, or a lyophilized platelet fragment, and wherein the binding agent-containing monolithic solid material is formed by a process comprising the steps of

mixing the binding agent with a fluid material that is to become the monolithic solid material so that the binding agent becomes evenly distributed within the fluid material to form a mixture,

forming the mixture into a desired shape and allowing the mixture to solidify to form a monolithic solid material having the desired shape and wherein the binding agent is not a participant in a reaction of solidifying the mixture.

19. A method for preparing a binding agent-containing monolithic solid material wherein the binding agent is evenly dispersed throughout the monolithic solid material, wherein the binding agent is not chemically coupled to the monolithic solid material and wherein the binding agent is held in the monolithic solid material so that the binding agent does not leach or elute from the monolithic solid material, wherein at least a portion of the binding agent is exposed to a surface of the monolithic solid material in an orientation wherein the binding agent is bindable to a binding partner by specific binding and wherein the binding agent is a platelet, a lyophilized platelet, or a lyophilized platelet fragment, the method comprising the steps of:

mixing the binding agent with a fluid material that is to become the monolithic solid material so that the binding agent becomes evenly distributed within the fluid material to form a mixture,

forming the mixture into a desired shape and allowing the mixture to solidify to form a monolithic solid material having the desired shape and wherein the binding agent is not a participant in a reaction of solidifying the mixture.

20. The method according to claim 19 wherein the solid phase substrate is a plastic.

21. The method according to claim 19 wherein the plastic is a thermoplastic material which forms the fluid material when heated.

22. The method according to claim 19 wherein the fluid material contains a monomer or oligomer which forms the monolithic solid material when polymerized or cross-linked.

23. The method according to claim 22 wherein the monomer or oligomer is polymerized or crosslinked by heat or the addition of a chemical.