Assay device

A chromatographic assay device for detection or determination of an analyte comprising:

• (a) a first opposable component including a sample preparation means for receiving a sample to be assayed;
• and
• (b) a second opposable component including a chromatographic medium, the chromatographic medium further including a detection zone smaller than the chromatographic medium;
• wherein the first and second opposable components are brought into opposition so as to cause the sample preparation means to apply the sample to be tested to the chromatographic medium;
• wherein the detection zone contains a first specific binding partner to the analyte immobilized therein so that the analyte is detected by a labeled second specific binding partner to be bound to the analyte, the analyte being in turn directly bound to the first specific binding partner, the labeled second specific binding partner being indirectly bound to the first specific binding partner through the analyte, the labeled second specific binding partner either being present in either the first or second opposable component of the device prior to the initiation of an assay or being added to the assay device during the performance of the assay.

A chromatographic assay device for detection or determination of an analyte comprising:

• (a) a first opposable component including:
• (i) a chromatographic medium having first and second ends;
• (ii) a conducting means in operable contact with the first end of the chromatographic medium;
• and
• (iii) an absorbing means in operable contact with the second end of the chromatographic medium;
• and
• (b) a second opposable component including:
• (i) a first application means that is a sample application pad;
• and
• (ii) a second application means that is a detector application pad to which detecting reagent is applied;
• the first and second application means being positioned on the second opposable component such that they are not in operable contact when the first and second opposable components are not in opposition;
• wherein bringing the first and second opposable components into opposition places the conducting means in operable contact with the first application means and places the conducting means in operable contact with the second application means, thereby placing the first and second application means in operable contact with each other and applying the contents of the sample application pad and the detector application pad to the conducting means, and wherein the conducting means transfers the contents of the sample application pad and the detector application pad to the first end of the chromatographic medium of the first opposable component;
• wherein the detector application pad contains a first specific binding partner to the analyte in a form that is resolubilized by addition of an aqueous liquid to the detector application pad, the first specific binding partner being labeled with a detectable label, and the chromatographic medium further comprises a detection zone smaller in area than the chromatographic medium, the detection zone containing a second specific binding partner to the analyte immobilized thereto, such that a ternary complex comprising the first specific binding partner, the analyte, and the second specific binding partner forms at the detection zone if analyte is present in the sample, the second specific binding partner being bound directly to the analyte and the labeled first specific binding partner being bound indirectly to the second specific binding partner through the analyte.

A chromatographic assay device for the detection or determination of an analyte comprising:

• (a) a first opposable component including:
• (i) a chromatographic medium having first and second ends;
• (ii) a conducting means in operable contact with the first end of the chromatographic medium;
• (iii) an absorbing means in operable contact with the second end of the chromatographic medium;
• and
• (iv) a detector application pad in direct contact with the conducting means and positioned such that it is in indirect contact with the first end of the chromatographic medium;
• and
• (b) a second opposable component that is a sample application pad;
• wherein bringing the first and second opposable components into opposition causes the sample application pad to apply a sample to be tested to the detector application pad and thus to the first end of the chromatographic medium through the conducting means;
• wherein the detector application pad contains a first specific binding partner to the analyte in a form that is resolubilized by addition of an aqueous liquid to the detector application pad, the first binding partner being labeled with a detectable label, and the chromatographic medium further includes a detection zone smaller than the chromatographic medium, the detection zone containing a specific binding partner to the analyte immobilized thereto, such that a try complex comprising the first specific binding partner, the analyte, and the second specific binding partner forms at the detection zone if analyte is present in the sample, the labeled first specific binding partner being indirectly bound to the immobilized second specific binding partner through the analyte in the ternary complex.

A chromatographic assay device for the detection or determination of an analyte comprising:

• (a) a first opposable component including:
• (i) a chromatographic medium having first and second ends;
• (ii) an absorbing means in operable contact with the second end of the chromatographic medium;
• and
• (iii) a detector application pad in direct contact with the first end of the chromatographic medium;
• (b) a second opposable component including a sample application pad;
• wherein, where the first and second opposable components are brought into opposition, the detector application pad and the sample application pad are in contact except for a region of the sample application pad directly adjacent to the first end of the chromatographic medium, and whereby bringing the first and second opposable components into opposition causes the sample application pad to apply the sample to be tested to the detector application pad and thus the first end of the chromatographic medium;
• wherein the detector application pad contains a first specific binding partner to the analyte in a form that is resolubilized by addition of an aqueous liquid to the detector application, the first specific binding partner being labeled with a detectable label, and the detection zone is smaller in area than the chromatographic medium, the detection zone containing a second specific binding partner to the analyte immobilize thereto, such that a ternary complex comprising the first specific binding partner, the analyte, and the second specific binding partner forms at the detection zone if the analyte is present in the sample.