Assay for anti-polyvinyl alcohol antibodies

Abstract

An assay kit for use in detecting an anti-polyvinyl alcohol antibody (anti-PVAL), comprises: polyvinyl alcohol (PVAL) attached to a support material; and an indicator reagent comprising a binding member that is specific for a human antibody; wherein the binding member is conjugated to a detectable label, and the binding member is capable of forming a complex with an anti-PVAL antibody. The kit can be used in a method for detecting antipolyvinyl alcohol (anti-PVAL) antibodies in test samples, such as serum, which comprises combining a test sample (e.g., serum) with the PVAL-bound support material to form a binary complex of the PVAL with an anti-PVAL antibody in the sample, followed by reacting the indicator reagent with the binary complex to form a labeled ternary complex, and then detecting the presence or absence of the ternary complex.

What is claimed is: 
     
         1 . A kit for use in detecting an anti-polyvinyl alcohol antibody (anti-PVAL), comprising:
 (a) polyvinyl alcohol (PVAL) attached to a support material; and   (b) an indicator reagent comprising a binding member that is specific for a human antibody;   wherein the binding member of the indicator reagent is conjugated to a detectable label, and the binding member is capable of forming a complex with an anti-PVAL antibody.   
     
     
         2 . The kit of  claim 1 , further comprising a wash composition for separating non-complexed materials from the support material when contacted therewith. 
     
     
         3 . The kit of  claim 2 , wherein the wash composition comprises a buffer solution. 
     
     
         4 . The kit of  claim 1 , wherein the detectable label comprises one or more material selected from the group consisting of a protein, an enzyme, a radioisotope, a nucleic acid segment, a fluorochrome, and a fluorescent protein. 
     
     
         5 . The kit of  claim 1 , wherein the detectable label is an enzyme 
     
     
         6 . The kit of  claim 5 , wherein the indicator reagent affords a colorimetric or chemiluminescent signal in the presence of the enzyme. 
     
     
         7 . The kit of  claim 5 , wherein the enzyme catalyzes the conversion of a non-colorimetric reagent to a colorimetric product. 
     
     
         8 . The kit of  claim 5 , wherein the enzyme is horseradish peroxidase, alkaline phosphatase, or beta-galactosidase. 
     
     
         9 . The kit of  claim 1 , wherein the solid support comprises one or more material selected from the group consisting of nitrocellulose, polyvinylidene difluoride (PVDF), and nylon. 
     
     
         10 . The kit of  claim 1 , wherein the solid support comprises one or more material selected from the group consisting of polypropylene, polystyrene, polyvinylchloride, polyamide, polycarbonate, polyether, polymethyl methacrylate, nitrocellulose, polyvinylidene difluoride, agarose, metal, and nylon. 
     
     
         11 . The kit of  claim 1 , wherein the solid support comprises a membrane, plastic beads, agarose beads, or magnetic beads. 
     
     
         12 . The kit of  claim 1 , wherein the solid support comprises a microtiter plate. 
     
     
         13 . The kit of  claim 1 , wherein the solid support is a microtiter plate and the PVAL is bound to specified wells of the microtiter plate. 
     
     
         14 . The kit of  claim 1 , wherein the solid support is in the form of a strip and the PVAL is bound to specified regions of the strip.