Immunoassay test strip for use in a diagnostic system
AssigneeHologic, Inc.
InventorLina Baydoun
Life of this patent
Estimating the term…
Abstract
An immunoassay test strip includes a sample pad for receiving a liquid patient sample; a conjugate pad fluidly coupled to the sample pad, wherein the conjugate pad contains a substantially uniform application of conjugate reagent; a contact pad fluidly coupled to the conjugate pad; a porous or bibulous member, e.g., made from nitrocellulose, fluidly coupled to the contact pad which is capable or transporting a liquid sample along the test strip, wherein the porous or bibulous member serves as the solid support upon which immunoreactions occur, and an absorbent pad fluidly coupled to the porous or bibulous member, which serves to draw sample fluid introduced onto the sample pad through the respective conjugate pad, contact pad and porous or bibulous member.
Claims12
An immunoassay test strip, wherein results of an immunoassay test of a patient sample are detectable by a change in color or other property of the resulting immunoassay test strip using a reflectance reader, and wherein the immunoassay test strip is manufactured by performing the steps of
- applying a porous or bibulous member to a substrate, wherein the porous or bibulous member is capable of transporting a liquid sample and serves as a solid support upon which immunoreactions may occur;
- adhering a contact pad to the substrate adjacent a first end of the porous or bibulous member, with an edge of the contact pad overlaying, so as to be fluidly coupled with, the porous or bibulous member;
- adhering a conjugate pad to the substrate adjacent the contact pad, with an edge of the conjugate pad overlaying, so as to be fluidly coupled with, the contact pad;
- applying a conjugate reagent to the conjugate pad through a striping process, so that the conjugate pad thereafter contains a substantially uniform application of conjugate reagent;
- attaching a sample pad to the substrate adjacent the conjugate pad, with an edge of the sample pad overlaying, so as to be fluidly coupled with, the conjugate pad, the sample pad comprising material suitable for receiving a liquid patient sample;
- and
- attaching an absorbent pad to the substrate adjacent a second end of the porous or bibulous member opposite the first end, with an edge of the absorbent pad overlaying, so as to be fluidly coupled with, the porous or bibulous member, wherein the absorbent pad serves to draw sample fluid introduced onto the sample pad through the respective conjugate pad, contact pad, and porous or bibulous member,
- wherein the presence of the contact pad during the striping process prevents excess liquid conjugate reagent from wicking from the conjugate pad into the porous or bibulous material, while still allowing for a combination of patient sample liquid and conjugate reagent to flow from the conjugate pad, through the contact pad, into the porous or bibulous material during a subsequent immunoassay test.
Dependencies are inferred from the claim text.