Multiple component chromatographic assay device

A chromatographic assay device comprising:

• a first opposable component, including (1) a sample preparation means for receiving a liquid sample to be assayed and (2) a chromatographic medium which is not in communication with the sample preparation means and having at least one reagent binding specifically to an analyte to be detected, the reagent being bound at a detection zone on the chromatographic medium;
• and
• a second opposable component including a connecting member for transferring fluid from the sample preparation means to the chromatographic medium;
• wherein the first and second opposable components can be brought into opposition by direct manual closure from a position in which they are not into opposition so as to cause the connecting member to establish a communication between the sample preparation means and the chromatographic medium so as to result in the application of the liquid sample to the chromatographic medium through the connecting member and in flow of the sample through the chromatographic medium, the chromatographic assay being performed in the detection zone as a result of migration of the sample within the chromatographic medium so that the analyte is detected within the chromatographic medium as the result of migration, the analyte being detected at a position different than the position at which the sample is applied to the chromatographic medium, the analyte being detected on the chromatographic medium at the detection zone by binding of a labeled mobile reagent that binds specifically to the analyte to be detected.

A chromatographic assay device for detecting the presence of H. pylori antibodies in a sample comprising:

• a first opposable component including:
• (i) a chromatographic medium having first and second ends and a reagent that specifically binds H. pylori antibodies, the reagent being bound at a detection zone on the chromatographic medium and (ii) a first application means at the first end of the chromatographic medium, the detection zone being located between the first application means and the second end of the chromatographic medium;
• and
• a second opposable component including a second application means and an absorbing means;
• wherein addition of a first liquid sample to the first application means causes a first liquid sample to flow from the first end of the chromatographic medium toward the second end of the chromatographic medium;
• and wherein bringing the first and second opposable components into opposition:
• (1) causes the second application means to come into contact with the second end of the chromatographic medium so as to apply a second liquid to the second end of the chromatographic medium, said second liquid containing a labeled mobile reagent that specifically binds H. Pylori antibodies, and (2) causes the absorbing means to come into contact with the first application means so as to withdraw fluid from the chromatographic medium via the first application means, thus reversing the flow in the chromatographic medium, the chromatographic assay being performed as a result of migration of the sample within the chromatographic medium so that H. pylori antibodies are detected as the result of the migration of the sample in a first direction within the chromatographic medium and of the second liquid applied to the chromatographic medium in a second direction opposite to the first direction, the H. pylori antibodies being detected at a position different than the position at which the sample is applied to the chromatographic medium by binding of the labeled mobile reagent to the H. pylori antibodies bound to the detection zone.

A method for detecting an analyte in a liquid sample using a chromatographic medium having

• (a) a first end and second end with a detection zone located between said first end and said second end, said detection zone comprising an immobilized antigen for said analyte, and
• (b) a labeled antibody reagent that binds to said analyte impregnated on said second end of said chromatographic medium, said method comprising:
• applying said sample to said first end of said chromatographic medium whereby said sample migrates toward said second end of said chromatographic medium into said detection zone and said analyte binds to said immobilized antigen to form an immobilized analyte,
• applying a liquid migrating agent to said second end of said chromatographic medium whereby said liquid migrates, along with said labeled antibody reagent, toward said first end of said chromatographic medium into said detection zone and said labeled antibody reagent binds to said immobilized analyte, permitting detection of said analyte.

A chromatographic assay device comprising:

• a first opposable component including:
• (i) a chromatographic medium having first and second ends and a reagent that specifically binds an analyte to be detected, the reagent being bound at a detection zone on the chromatographic medium, (ii) a first application means impregnated with an inert dye adjacent to and in communication with the first end of the chromatographic medium, and (iii) a reagent pad impregnated with a labeled antibody reagent adjacent to and in communication with the second end of the chromatographic medium, the detection zone being located between the first application means and the reagent pad;
• and
• a second opposable component including a second application means containing a buffer solution and an absorbing means;
• wherein addition of a first liquid sample to the first application means causes the first liquid sample and the inert dye to flow from the first end of the chromatographic medium toward the second end of the chromatographic medium;
• and wherein bringing the first and second opposable components into opposition:
• (1) causes the second application means containing the buffer solution to come into contact with the reagent pad so as to apply the buffer solution and labeled antibody reagent to the second end of the chromatographic medium and
• (2) causes the absorbing means to come into contact with the first application means so as to withdraw fluid from the chromatographic medium via the first application means, thus reversing the flow in the chromatographic medium, the chromatographic assay being performed as a result of migration of the sample and inert dye within the chromatographic medium so that an analyte is detected as the result of the migration of the sample and inert dye in a first direction within the chromatographic medium and of the buffer solution and labeled antibody reagent applied to the chromatographic medium in a second direction opposite to the first direction, the analyte being detected at a position different than the position at which the sample and inert dye are applied to the chromatographic medium by binding of the labeled reagent to the analyte bound to the detection zone.