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Lateral flow assay with test strip retainer

  • US 10,408,828 B2
  • Filed: 02/25/2014
  • Issued: 09/10/2019
  • Est. Priority Date: 02/26/2013
  • Status: Active Grant
First Claim
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1. A method of forming a lateral flow test device, comprising:

  • providing a first mold assembly which forms a test device base as a non-strippable article, the test device base comprising on a floor thereof a first vertical wall and a second vertical wall forming a recess having a defined width therebetween, the first vertical wall comprising one or more first compression structures and the second vertical wall comprising one or more second compression structures, wherein the first and second compression structures define an undercut portion between the first vertical wall and second vertical wall;

    introducing a moldable material into the first mold assembly to form the test device base;

    removing the test device base from the first mold assembly;

    providing a test strip comprisinga substantially uncompressible and nonabsorbent base layer,a first bibulous material disposed on the base layer at a proximal end thereof and forming a sample receiving region,a second bibulous material disposed on the base layer at a distal end thereof and forming an absorbent region, wherein the second bibulous material is compressible, anda porous membrane disposed on the base layer between the proximal and distal ends thereof and fluidly connected to the first bibulous material and the second bibulous material,the test strip defining a flow path wherein a sample applied to the sample receiving region flows through the porous membrane to the absorbent region, wherein the porous membrane comprises one or more test zones, each test zone comprising one or more reagents configured to bind for detection one or more analyte of interest; and

    inserting the test strip into the test device base such that the base layer inserts into the undercut portion and such that upon completing the insertion the second bibulous material is contacted by the first compression structures and the second compression structures.

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