Assay devices with mobile control reagents
AssigneeAbbott Laboratories
InventorsRichard T. Flanders, Vincent A. Varitek, Jr.
Life of this patent
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Abstract
The present invention relates to an improved immunoassay device for confirming the validity of a test result showing either the presence or absence of an analyte in a patient sample. In the improved device, control reagents are provided in the device which directly mimic the reaction of the sample analyte with the test reagents of the device. The device thus allows the user to verify the efficacy of the test reagents at all stages of interaction with the sample analyte.
Claims13
In an analytical device for determining the presence or amount of an analyte in a test sample, having a strip with a proximal end and a distal end, wherein the test sample can travel from said proximal end to about said distal end by capillary action, and wherein said strip contains an immobilized patient capture reagent which binds to a member selected from the group consisting of the analyte, an ancillary specific binding member and a labeled reagent,
- the improvement comprising:
- a) a mobile positive control reagent;
- b) an immobilized positive control capture reagent that is located at a site downstream from the mobile positive control reagent and is capable of binding the mobile positive control reagent.
A kit for use in specific binding assays, having an analytical device for determining the presence or amount of an analyte in a test sample, comprising a strip having a proximal end and a distal end, wherein the test sample can travel from said proximal end to about said distal end by capillary action, and wherein said strip contains an immobilized patient capture reagent which binds to a member selected from the group consisting of the analyte, an ancillary specific binding member and a labeled reagent,
- the improvement comprising:
- a) a mobile positive control reagent;
- b) an immobilized positive control capture reagent that is located at a site downstream from the mobile positive control reagent and is capable of binding the mobile positive control reagent.
Dependencies are inferred from the claim text.