One-step lateral flow assays
AssigneeQuidel Corporation
InventorsAllan D. Pronovost, Hans Boehringer, Ya-Chen Hsu
Life of this patent
Estimating the term…
Abstract
The efficiency and accuracy of one-step lateral flow assays can be improved by employing more efficient binding between participants in labeling and capture. Thus, in addition to analyte/anti-analyte interactions, specific binding is achieved through members of an irrelevant specific binding pair. Also included within the invention is a format wherein unlabeled competitor for analyte serves as a gatekeeper in the capture zone, competing with analyte for labeled anti-analyte, which analyte will be captured in a detecting portion of a capture zone.
Claims6
A test strip suitable for a lateral flow assay, which test strip comprises a sample-receiving zone, a labeling zone and a capture zone,
- wherein said sample-receiving zone contains a single movably bound first anti-analyte coupled to a first member of a first specific binding pair irrelevant to analyte/anti-analyte interaction,
- wherein said labeling zone contains a movably bound counter member of said first specific binding pair irrelevant to analyte/anti-analyte interaction, said counter member is coupled to a label, and
- wherein said capture zone is separated into a gatekeeping zone proximal to said sample-receiving zone that contains a movably bound second anti-analyte coupled to a first member of a second specific binding pair irrelevant to analyte/anti-analyte interaction and a detecting zone distal to said sample-receiving zone that contains an immobilized counter member of said second specific binding pair irrelevant to analyte/anti-analyte interaction.
A method to determine the presence, absence or amount of an analyte in a sample in a one-step lateral flow assay conducted on a test strip, which method comprises:
- a) providing a test strip suitable for a one-step lateral flow assay, which test strip comprises a sample-receiving zone, a labeling zone and a capture zone, wherein said sample-receiving zone contains a single movably bound first anti-analyte coupled to a first member of a first specific binding pair irrelevant to analyte/anti-analyte interaction, said labeling zone contains a movably bound counter member of said first specific binding pair irrelevant to analyte/anti-analyte interaction, said counter member is coupled to a label, and said capture zone is separated into a gatekeeping zone proximal to said sample-receiving zone that contains a movably bound second anti-analyte coupled to a first member of a second specific binding pair irrelevant to analyte/anti-analyte interaction and a detecting zone distal to said sample-receiving zone that contains an immobilized counter member of said second specific binding pair irrelevant to analyte/anti-analyte interaction;
- b) applying a fluid sample containing or suspected of containing an analyte to said sample-receiving zone, and allowing said sample to flow through said labeling zone and into said capture zone and carrying said analyte, if present, said first anti-analyte, said movably bound counter member and said movably bound second anti-analyte into said detecting zone to form a first anti-analyte/analyte/second anti-analyte complex, wherein said label is linked to said complex through the interaction between said first member and counter member of said first specific binding pair and said second anti-analyte in said complex is bound to said test strip through the interaction between said first member and counter member of said second specific binding pair;
- and
- c) assessing the presence, absence or amount of label in said first anti-analyte/analyte/second anti-analyte complex to determine the presence, absence or amount of said analyte in said sample.
Dependencies are inferred from the claim text.