Phadia Ab

Kimberly-clark Worldwide, Inc.

Paul Christopher

Gerd Rundström

Per Matsson

Xuedong Song

Gerd Rundstrom

A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, and to travel to a second location downstream of the first location where the mobilized labeled reagent causes a visible change to occur at the second location.

Two step lateral flow assay methods and devices

Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations. In one embodiment, a method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location, allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location and allowing sample to dissolve a water-soluble mark, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample delivery location, and allowing labeled reagent to bind any IgE antibody bound to the immobilized IgE antigen species therein.

A lateral flow assay device for detecting the presence or quantity of an analyte within a test sample is provided. The device utilizes multiple zones, one of which serves as an indicator of whether or not the analyte in the test sample is within the 'hook effect' region. Based on this indication, a technique may be selected for correlating a measured signal intensity to an analyte concentration or range of concentrations. For example, when it is determined that the test sample falls outside the 'hook effect' region, the analyte concentration may be determined using one portion of a dose response curve. On the other hand, when it is determined that the test sample falls within the &#x201c;hook effect&#x201d; concentration, the analyte concentration may be determined using another portion of the dose response curve. Alternatively, the sample may simply be diluted for re-performing the assay. The present inventor has discovered that such a detection technique may simply, quickly and accurately detect an analyte present at any concentration.

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Rhondda Cynon Taf, United Kingdom

Paul Christopher