Toxins and antibodies of C. difficile

Claim 2

In an assay process for toxin A of C. difficile wherein an analyte containing toxin A is contacted with an antibody, the improvement comprising: contacting said analyte with monospecific antibody for toxin A of C. difficile to bind only toxin A to said mono-specific antibody.

Claim 3

The process of claim 1 wherein in the assay antibody to C. difficile is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind C. difficile antigen to the supported C. difficile antibody and subsequently the bound antigen is contacted with mono-specific antibody in a labelled form and the presence of said toxin is determined by detecting the presence of bound label.

Claim 4

The process of claim 2 wherein the label is an enzyme label.

Claim 5

The process of claim 3 wherein the enxyme label is alkaline phosphatase.

Claim 6

The process of claim 1 wherein in the assay antibody to C. difficile is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind the C. difficile antigen to the C. difficile antibody, the antigen is contacted with mono-specific antibody to bind mono-specific antibody to toxin A of the bound antigen, subsequently bound mono-specific antibody is contacted with a labelled form of antibody for the mono-specific antibody, and the presence of said toxin A is determined by detecting the presence of bound label.

Claim 7

The process of claim 5 wherein the label is an enzyme label.

Claim 8

The process of claim 6 wherein the enzyme label is alkaline phosphatase.

Claim 9

The process of claim 1 wherein the monospecific antibody is supported on solid particles, and the presence of toxin A is determined by agglutination of the solid particles.

Claim 10

The process of claim 1 wherein the antibody is supported on a solid support.

Claim 11

The process of claim 9 wherein the analyte is present in a feces sample.

Claim 12

In an assay process for toxin B of C. difficile wherein an analyte containing toxin B is contacted with an antibody, the improvement comprising: contacting said analyte with monospecific antibody for toxin B of C. difficile to bind only toxin B to said mono-specific antibody.

Claim 13

In an assay process for toxin B of C. difficile wherein an analyte containing toxin B is contacted with an antibody, the improvement comprising: contacting said analyte with monospecific antibody for toxin B of C. difficile to bind only toxin B to said mono-specific antibody.

Claim 14

The process of claim 11 wherein in the assay antibody to C. difficile is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind C. difficile antigen to the supported C. difficile antibody and subsequently the bound antigen is contacted with mono-specific antibody in a labeled form and the presence of said toxin is determined by detecting the presence of bound label.

Claim 15

The process of claim 12 wherein the label is an enzyme label.

Claim 16

The process of claim 13 wherein the enzyme label is alkaline phosphatase.

Claim 17

The process of claim 11 wherein in the assay antibody to C. difficile is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind the C. difficile antigen to the C. difficile antibody, the antigen is contacted with mono-specific antibody to bind mono-specific antibody to toxin B of the bound antigen, subsequently bound mono-specific antibody is contacted with a labelled form of antibody for the mono-specific antibody, and the presence of said toxin B is determined by detecting the presence of bound label.

Claim 18

The process of claim 15 wherein the label is an enzyme label.

Claim 19

The process of claim 16 wherein the enzyme label is alkaline phosphatase.

Claim 20

The process of claim 11 wherein the monospecific antibody is supported on solid particles and the presence of toxin B is determined by agglutination of the solid particles.

Claim 21

The process of claim 11 wherein the antibody is supported on a solid support.

Claim 22

The process of claim 19 wherein the analyte is present in a feces sample.

Claim 23

In an assay process for toxigenic C. difficile wherein an analyte containing toxigenic C. difficile is contacted with an antibody, the improvement comprising: contacting said analyte with antibody specific for toxins of C. difficile to bind only C. difficile toxins to the antibody.

Claim 24

In an assay process for toxigenic C. difficile wherein an analyte containing toxigenic C. difficile is contacted with an antibody, the improvement comprising: contacting said analyte with antibody specific for toxins of C. difficile to bind only C. difficile toxins to the antibody.

Claim 25

The process of claim 21 wherein in the assay antibody to C. difficle is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind C. difficile antigen to the supported C. difficile antibody and subsequently the bound antigen is contacted with mono-specific antibody in a labelled form and the presence of said toxin is determined by detecting the presence of bound label.

Claim 26

The process of claim 2 wherein the label is an enzyme label.

Claim 27

The process of claim 23 wherein the enzyme label is alkaline phosphatase.

Claim 28

The process of claim 21 wherein in the assay antibody to C. difficile is supported on a solid support, the supported C. difficile antibody is contacted with analyte to bind the C. difficile antigen to the C. difficile antibody, the antigen is contacted with mono-specific antibody to bind mono-specific antibody to C. difficile toxins of the bound antigen, subsequently bound mono-specific antibody is contacted with a labelled form of antibody for the mono-specific antibody, and the presence of said C. difficile toxins is determined by detecting the presence of bound label.

Claim 29

The process of claim 25 wherein the label is an enzyme label.

Claim 30

The process of claim 26 wherein the enzyme label is alkaline phosphatase.

Claim 31

The process of claim 21 wherein the antibody is supported on solid particles and the presence of toxigenic C. difficile is determined by agglutination of the solid particles.

Claim 32

A process for providing antibodies specific for toxins of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the non-toxic heat stable antigen thereto; and recovering antibody specific for toxins of C. difficile.

Claim 33

A process for providing antibodies specific for toxins of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the non-toxic heat stable antigen thereto; and recovering antibody specific for toxins of C. difficile.

Claim 34

The process of claim 29 wherein the non-toxic C. difficile protein antigen is in the form of whole cells of a non-toxic strain of C. difficile.

Claim 35

The process of claim 30 wherein the non-toxic heat stable antigen of C. difficile is supported on a solid support.

Claim 36

The process of claim 29 wherein the antibody is supported on a solid support.

Claim 37

A process for providing mono-specific antibody for toxin A of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the non-toxic heat stable antigen thereto; recovering antibody specific for toxins of C. difficile; contacting antibody specific for toxins of C. difficile with toxin A of C. difficile supported on a solid support to bind mono-specific antibody for toxin A thereto; and subsequently eluting mono-specific antibody for toxin A therefrom.

Claim 38

A process for providing mono-specific antibody for toxin A of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the non-toxic heat stable antigen thereto; recovering antibody specific for toxins of C. difficile; contacting antibody specific for toxins of C. difficile with toxin A of C. difficile supported on a solid support to bind mono-specific antibody for toxin A thereto; and subsequently eluting mono-specific antibody for toxin A therefrom.

Claim 39

The process of claim 33 wherein the non-toxic C. difficile protein antigen is in the form of whole cells of a non-toxic strain of C. difficille.

Claim 40

The process of claim 34 wherein the non-toxic heat stable antigen of C. difficile is supported on a solid support.

Claim 41

A process for providing mono-specific antibody for toxin B of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the nontoxic heat stable antigen thereto; recovering antibody specific for toxins of C. difficile; contacting antibody specific for toxins of C. difficile with toxin B of C. difficile supported on a solid support to bind mono-specific antibody for toxin B thereto; and subsequently eluting mono-specific antibody for toxin B therefrom.

Claim 42

A process for providing mono-specific antibody for toxin B of C. difficile, comprising: contacting C. difficile antibody, which includes antibodies specific for toxins of C. difficile, antibody to non-toxic protein antigen and antibody to non-toxic heat stable antigen with non-toxic C. difficile protein antigen to bind antibody to non-toxic protein antigen thereto; contacting said C. difficile antibody free of antibody to non-toxic protein antigen with a non-toxic heat stable antigen of C. difficile to bind the antibody for the nontoxic heat stable antigen thereto; recovering antibody specific for toxins of C. difficile; contacting antibody specific for toxins of C. difficile with toxin B of C. difficile supported on a solid support to bind mono-specific antibody for toxin B thereto; and subsequently eluting mono-specific antibody for toxin B therefrom.

Claim 43

The process of claim 36 wherein the non-toxic C. difficile protein antigen is in the form of whole cells of a non-toxic strain of C. difficile.

Claim 44

The process of claim 37 wherein the non-toxic heat stable antigen of C. difficile is supported on a solid support.