Immunoassay for H. Pylori in fecal specimens

A process for the determination of H. pylori in a fecal specimen which comprises:

• (a) dispersing a fecal specimen suspected of carrying H. pylori in a sample diluent;
• (b) contacting the fecal specimen in the diluent with a first polyclonal antibody for H. pylori antigen bound to a solid carrier and a second labelled polyclonal antibody for H. pylori to form a complex of the antibodies and the antigen;
• (c) separating said specimen and said complex;
• (d) determining the amount of the labelled antibody and in turn determining the presence of H. pylori antigen in said fecal specimen.

A process for the determination of H. pylori in a fecal specimen which comprises:

• (a) dispersing a fecal specimen suspected of carrying H. pylori in a sample diluent;
• (b) contacting the fecal specimen in the diluent with a first polyclonal antibody for H. pylori antigen produced by a first antibody-producing species and bound to a solid carrier to form a complex of the antibody and the antigen;
• (c) separating said specimen and said complex;
• (d) contacting the antibody-antigen complex formed in step (b) with a primary polyclonal antibody for H. pylori antigen obtained from a second antibody-producing species to produce a antibody-antigen-antibody complex;
• (e) removing the primary antibody not present in the complex from step (d);
• (f) contacting the antibody-antigen-antibody complex formed in step (d) with a secondary antibody, said secondary antibody being an antibody for the second antibody-producing species, whereby said secondary antibody forms a complex with said antibody-antigen-antibody complex;
• and
• (g) determining the presence of H. pylori antigen in said fecal specimen.

A process for the determination of H. pylori in a fecal specimen which comprises:

• (a) dispersing a fecal specimen suspected of carrying H. pylori in a sample diluent;
• (b) contacting the fecal specimen in the diluent with a first polyclonal antibody for H. pylori antigen to form a complex of the first polyclonal antibody and the antigen;
• (c) separating said specimen and said complex;
• (d) exposing the complex to a second polyclonal antibody for said antigen and a portion of the second polyclonal antibody reacting with said complex, one of said first and second polyclonal antibody being bound to a solid carrier and the other being labeled with a detection agent;
• and
• (e) determining the presence in said complex of the antibody labeled with the detection agent and in turn determining the presence of H. pylori antigen in said fecal specimen.

A process for the determination of H. pylori in a fecal specimen which comprises:

• (a) dispersing a fecal specimen suspected of carrying H. pylori in a sample diluent;
• (b) contacting the fecal specimen in the diluent with a first polyclonal antibody for H. pylori antigen bound to a solid carrier and a second labeled polyclonal antibody for H. pylori antigen to form a complex of the first and second antibodies and the antigen;
• (c) separating said specimen and said complex;
• (d) determining the presence in said complex of the labeled antibody and in turn determining the presence of H. pylori antigen in said fecal specimen.