Process for producing immunological diagnostic reagents

Claim 2

A process for producing a water-insoluble immunological diagnostic reagent comprising: (a) providing an immunologically inert carboxylated latex polymer which is substantially free from any contaminating amino compounds; (b) mixing said immunologically inert carboxylated latex polymer with a water-soluble activating agent; and (c) adding an immunologically active material thereto to link the immunologically active material with the immunological inert carboxylated latex polymer, and thereby form the diagnostic reagent.

Claim 3

The process of claim 1 wherein step (a) comprises: (a) procuring an immunologically inert carboxylated latex polymer; and (b) pretreating said latex polymer to remove any amino compounds.

Claim 4

The process of claim 2 wherein the latex polymer is pretreated by: (a) washing said latex polymer with water; and (b) treating the washed latex polymer with a cationic ion exchange resin.

Claim 5

The process of claim 1 or 3 wherein the concentration of the water-soluble activating agent is about 0.005% to about 6% by weight.

Claim 6

The process of claim 1 or 3 wherein the water-soluble activating agent is a water-soluble carbodiimide.

Claim 7

The process of claim 5 wherein the water-soluble carbodiimide is 1-cyclohexyl-3-[2-morpholinyl-(4)-ethyl]-carbodiimide metho-p-toluenesulfonate.

Claim 8

The process of claim 1 or 3 wherein the immunologically inert carboxylated latex polymer approximately has the specific gravity of water and a particle size of about 0.01 to about 0.9 microns.

Claim 9

The process of claim 1 or 3 wherein the immunologically active material is linked to the immunologically inert latex polymer in an amount of about 0.01% to about 15.0% by weight.

Claim 10

The process of claim 1 or 3 wherein the immunologically inert carboxylated latex polymer is a water-insoluble carboxylated styrene butadiene copolymer.

Claim 11

The process of claim 1 or 3 wherein the immunologically active material is human chorionic gonadotropin.

Claim 12

The process of claim 1 or 3 wherein the immunologically active material is human albumin.

Claim 13

The process of claim 1 or 3 wherein the immunologically active material is denatured gamma globulin.

Claim 14

The process of claim 1 or 3 wherein the immunologically active material is human placental lactogen.

Claim 15

The process of claim 1 or 3 wherein the immunologically active material is an antibody against albumin.

Claim 16

The process of claim 1 or 3 wherein the immunologically active material is an antibody against IgA.

Claim 17

The process of claim 1 or 3 wherein the immunologically active material is an antibody against IgG.

Claim 18

The process of claim 1 or 3 wherein the immunologically active material is an antibody against IgM.

Claim 19

A process for manufacturing a water-insoluble immunological diagnostic reagent approximately having the specific gravity of water comprising: (a) providing discrete particles of carboxylated latex polymer which are immunologically inert; (b) pretreating said latex polymer to remove any amino compounds therefrom; (c) providing an activating agent which is water soluble; (d) mixing said pretreated latex polymer with said activating agent to activate the pretreated latex polymer; and (e) adding immunologically active material to the activated latex polymer to link the activated latex polymer to the active material by an amide link and thereby form the diagnostic reagent.

Claim 20

A process for manufacturing a water-insoluble immunological diagnostic reagent approximately having the specific gravity of water comprising: (a) providing discrete particles of carboxylated latex polymer which are immunologically inert; (b) pretreating said latex polymer to remove any amino compounds therefrom; (c) providing an activating agent which is water soluble; (d) mixing said pretreated latex polymer with said activating agent to activate the pretreated latex polymer; and (e) adding immunologically active material to the activated latex polymer to link the activated latex polymer to the active material by an amide link and thereby form the diagnostic reagent.

Claim 21

The process of claim 18 wherein the latex polymer is pretreated by: (a) washing the latex polymer with water; and (b) treating the washed latex polymer with a cationic ion exchange resin.

Claim 22

The process of claim 19 wherein the water-soluble activating agent is a water-soluble carbodiimide.

Claim 23

The process of claim 19 or 20 wherein the carboxylated latex polymer is a water-insoluble carboxylated styrene butadiene copolymer.