Method and device for chlamydia detection

A device for determining the presence or amount of Chlamydia in a solubilized sample, said device comprising:

• a matrix defining a flow path comprising at least a labelling zone and a capture zone;
• said labelling zone comprising a labelling complex, wherein the labelling complex comprises a visual label bound to an antibody that specifically binds an epitope of a Chlamydia lipopolysaccharide antigen, and wherein the labelling zone further comprises a zwitterionic buffer;
• and
• said capture zone comprising an immobilized antibody which specifically binds an epitope of the Chlamydia lipopolysaccharide antigen.

A kit for determining the presence or amount of Chlamydia in a swab sample, said kit comprising:

• a device comprising:
• a) a matrix defining a flow path comprising at least a labelling zone and a capture zone;
• b) said labelling zone comprising a labelling complex, wherein the labelling complex comprises a visual label bound to an antibody that specifically binds an epitope of a Chlamydia lipopolysaccharide antigen;
• and
• c) said capture zone comprising an immobilized antibody which specifically binds an epitope of the Chlamydia lipopolysaccharide antigen;
• a swab receptacle;
• a first reagent container holding an alkaline solution having a pH of at least 9.0 for extracting a swab sample in the receptacle;
• a second reagent container holding a solution of a zwitterionic detergent, a zwitterionic buffer, and an albumin for neutralizing the extract in the swab receptacle prior to application to the device;
• and
• packaging for holding the device, the swab receptacle, the first reagent container, and the second reagent container.