초록 ▼

Detection of bindable substances such as antibodies and antigens using enzyme linked immunosorbent assays having particular utility in home diagnostic applications. The preferred implementation of the invention is characterized by the steps of admixing a sample suspected of containing the bindable s

Detection of bindable substances such as antibodies and antigens using enzyme linked immunosorbent assays having particular utility in home diagnostic applications. The preferred implementation of the invention is characterized by the steps of admixing a sample suspected of containing the bindable substance to be detected with an antibody-enzyme conjugate, immersing an antibody coated solid support into the mixture and then exposing the coated support to an activated chromogenic solution. The conjugate for use in the home diagnostic assay is preferably contained within a lyophilized mixture. The lyophilized mixture contains components which preserve the antibody-conjugate\s reactivity and immunologic binding specificity even if the lyophilized mixture had been subjected to hot, humid environmental conditions. Active components in the lyophilized mixture include polyethylene glycol, sugars, and surfactant. The antibody coated support is treated with an improved blocking solution containing a blocking agent such as bovine serum albumin or milk protein in admixture with a sugar. The blocking solution prevents nonspecific binding of immunologic reagents to the support and protects the antibody on the support from loss of reactivity and immunologic binding specificity even if the antibody coated support had been subjected to hot, humid environmental conditions.

대표청구항 ▼

In a lyophilized mixture for use in an enzyme immunoassay, said mixture comprising an antibody-enzyme conjugate and buffer salts, wherein the improvement comprises that said enzyme in said antibody-enzyme conjugate comprises peroxidase and that said lyophilized mixture further comprises: (a) a bindi

In a lyophilized mixture for use in an enzyme immunoassay, said mixture comprising an antibody-enzyme conjugate and buffer salts, wherein the improvement comprises that said enzyme in said antibody-enzyme conjugate comprises peroxidase and that said lyophilized mixture further comprises: (a) a binding enhancing agent selected from the group consisting of polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone and dextran; (b) a water soluble non ionic surfactant, said surfactant being present in the mixture in an amount sufficient to provide an appropriate amount of detergency for said immunoassay without having a deleterious effect on the conjugate; and (c) a sugar selected from the group consisting of dextrin and trehalose, said sugar being present in the mixture in an amount sufficient to prevent discernible concentration gradients of the components in said mixture; said lyophilized mixture having the property of preserving the antibody reactivity and the immunologic binding specificity of the antibody-enzyme conjugate even if the mixture is exposed to temperatures between about 80°F. and 120°F. prior to its use in the immunoassay.