Determination of a chlamydial or gonococcal antigen using a positively-charged ionically binding support

Claim 1

A method for the determination of a chlamydial or gonococcal antigen comprising: A. contacting chlamydial or gonococcal antigen extracted from a specimen suspected of containing chlamydial or gonococcal organisms, respectively, with a polymeric solid support which is substantially free of any biological compound reactive with said antigen, and which has a multiplicity of positively charged groups on the surface thereof so as to ionically bind the chlamydial or gonococcal antigen directly to the solid support, B. within about 10 minutes of the contact, separating unbound materials from the ionically bound antigen and contacting the bound chlamydial or gonococcal antigen with chlamydial or gonococcal antibody, respectively, so as to form an immunological complex on the support, and C. within about 10 minutes of the antibody-antigen contact, separating the immunological complex from uncomplexed antibody and determining the presence of the complex on the support as a measure of the amount of chlamydial or gonococcal antigen, respectively, in the specimen, steps A through C being carried out within about 30 minutes.

Claim 2

A method for the determination of a chlamydial or gonococcal antigen comprising: A. contacting chlamydial or gonococcal antigen extracted from a specimen suspected of containing chlamydial or gonococcal organisms, respectively, with a polymeric solid support which is substantially free of any biological compound reactive with said antigen, and which has a multiplicity of positively charged groups on the surface thereof so as to ionically bind the chlamydial or gonococcal antigen directly to the solid support, B. within about 10 minutes of the contact, separating unbound materials from the ionically bound antigen and contacting the bound chlamydial or gonococcal antigen with chlamydial or gonococcal antibody, respectively, so as to form an immunological complex on the support, and C. within about 10 minutes of the antibody-antigen contact, separating the immunological complex from uncomplexed antibody and determining the presence of the complex on the support as a measure of the amount of chlamydial or gonococcal antigen, respectively, in the specimen, steps A through C being carried out within about 30 minutes.

Claim 9

A method for the determination of a chlamydial or gonococcal organisms comprising: A. extracting chlamydial or gonococcal antigen from chlamydial or gonococcal cells, respectively, in a biological specimen, B. contacting said chlamydial or gonococcal antigen with a polymeric solid support which is substantially free of any antibody for said antigen and which has a multiplicity of positively charged groups on the surface thereof so as to ionically bind said antigen directly to said solid support, C. within about 5 minutes of said contact, separating said unbound materials from said ionically bound antigen and contacting said bound antigen with unlabeled chlamydial or gonococcal antibody, respectively, so as to form an immunological complex on said support, D. separating said complex from uncomplexed materials, E. contacting said complex with a labeled anti-antibody to said chlamydial or gonococcal antibody so as to form a labeled antibody-antibody-antigen complex, F. within about 5 minutes of said contacting step E, separating said labeled complex from uncomplexed materials, and G. determining said labeled complex on said support as a measure of the amount of chlamydial or gonococcal organism in said specimen, steps A through G being carried out within about 30 minutes.

Claim 10

A method for the determination of a chlamydial or gonococcal organisms comprising: A. extracting chlamydial or gonococcal antigen from chlamydial or gonococcal cells, respectively, in a biological specimen, B. contacting said chlamydial or gonococcal antigen with a polymeric solid support which is substantially free of any antibody for said antigen and which has a multiplicity of positively charged groups on the surface thereof so as to ionically bind said antigen directly to said solid support, C. within about 5 minutes of said contact, separating said unbound materials from said ionically bound antigen and contacting said bound antigen with unlabeled chlamydial or gonococcal antibody, respectively, so as to form an immunological complex on said support, D. separating said complex from uncomplexed materials, E. contacting said complex with a labeled anti-antibody to said chlamydial or gonococcal antibody so as to form a labeled antibody-antibody-antigen complex, F. within about 5 minutes of said contacting step E, separating said labeled complex from uncomplexed materials, and G. determining said labeled complex on said support as a measure of the amount of chlamydial or gonococcal organism in said specimen, steps A through G being carried out within about 30 minutes.

Claim 19

A method for the determination of the lipopolysaccharide antigen of Chlamydia trachomatis comprising: A. extracting lipopolysaccharide antigen from Chlamydia trachomatis organisms in a biological specimen, B. contacting said extracted antigen with a polymeric solid support which is substantially free of any antibody for said antigen and which has a multiplicity of quaternary ammonium groups on the surface thereof so as to ionically bind said antigen directly to said support, C. within less than about 1 minute of said contact, separating uncomplexed materials from said ionically bound antigen and contacting said bound antigen with an unlabeled monoclonal chlamydial antibody to said antigen so as to form an immunological complex on said support, D. incubating for less than 5 minutes at room temperature, E. separating said complex from uncomplexed materials by washing, F. contacting said complex with a peroxidase-labeled antibody to said chlamydial antibody so as to form a peroxidase-labeled antibody-antibody-antigen complex, and incubating for up to about 5 minutes at room temperature, G. separating said labeled complex from uncomplexed materials by washing, H. adding a dye-providing composition comprising hydrogen peroxide and a triarylimidazole leuco dye which provides a dye in the presence of peroxidase and hydrogen peroxide, and I. determining the amount of said dye on said support as a measure of the amount of Chlamydia trachomatis in said specimen, steps B through I being carried out within about 30 minutes.

Claim 20

A method for the determination of the lipopolysaccharide antigen of Chlamydia trachomatis comprising: A. extracting lipopolysaccharide antigen from Chlamydia trachomatis organisms in a biological specimen, B. contacting said extracted antigen with a polymeric solid support which is substantially free of any antibody for said antigen and which has a multiplicity of quaternary ammonium groups on the surface thereof so as to ionically bind said antigen directly to said support, C. within less than about 1 minute of said contact, separating uncomplexed materials from said ionically bound antigen and contacting said bound antigen with an unlabeled monoclonal chlamydial antibody to said antigen so as to form an immunological complex on said support, D. incubating for less than 5 minutes at room temperature, E. separating said complex from uncomplexed materials by washing, F. contacting said complex with a peroxidase-labeled antibody to said chlamydial antibody so as to form a peroxidase-labeled antibody-antibody-antigen complex, and incubating for up to about 5 minutes at room temperature, G. separating said labeled complex from uncomplexed materials by washing, H. adding a dye-providing composition comprising hydrogen peroxide and a triarylimidazole leuco dye which provides a dye in the presence of peroxidase and hydrogen peroxide, and I. determining the amount of said dye on said support as a measure of the amount of Chlamydia trachomatis in said specimen, steps B through I being carried out within about 30 minutes.