Quality/process control of a lateral flow assay device based on flow monitoring

  • US 10,509,031 B2
  • Filed: 09/23/2016
  • Issued: 12/17/2019
  • Est. Priority Date: 11/15/2012
  • Status: Active Grant
First Claim
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1. A method for processing a lateral flow assay device, the lateral flow assay device comprising a substrate having at least one sample addition zone, a first detection zone downstream of the at least one sample addition zone, at least one wash zone down stream of the at least one sample addition zone and up stream of the first detection zone, and at least one wicking zone disposed downstream of the first detection zone wherein the at least one wicking zone includes a second detection zone, each of the zones being fluidly connected along a flow path in which a sample flows from the at least one sample addition zone to the at least one wicking zone, said method comprising the steps of:

  • adding a quantity of a sample to the at least one sample addition zone of the lateral flow assay device;

    combining the sample and a reagent, wherein the sample and reagent may be combined prior to the adding of the sample to the at least one sample addition zone or on the assay device, the reagent including a detection material that produces a detectable signal that flows through the remainder of the lateral flow assay device along the flow path; and

    triggering a process-related wash event including a dispense of at least one wash fluid into the at least one wash zone based upon the detection of the detectable signal in at least the first detection zone and a second signal at the second detection zone.

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