Michael R Kepron

US Patent:

7442557, Oct 28, 2008

Filed:

Oct 22, 2004

Appl. No.:

10/971212

Inventors:

Scott Marshall Clark - Cape Elizabeth ME, US
Michael Raymond Kepron - Standish ME, US

Assignee:

IDEXX Laboratories, Inc. - Westbrook ME

International Classification:

G01N 33/558

US Classification:

436514, 422 55, 422 56, 422 58, 4352877, 435810, 436169, 436808

Abstract:

A device for conducting an assay to determine the presence or amount of an analyte in a fluid sample. The device includes a flow path that facilitates fluidic flow by capillary action. The flow path has a first fluid permeable region, a second fluid permeable region, a barrier that inhibits fluidic flow between the first and second regions, and a fluidic bridge. The bridge includes a fluid permeable material overlapping at least a portion of each of the first region, the barrier and the second region.

US Patent:

20030040021, Feb 27, 2003

Filed:

Apr 3, 2002

Appl. No.:

10/116208

Inventors:

Scott Clark - Cape Elizabeth ME, US
Robert Suva - Windham ME, US
Michael Kepron - Standish ME, US
Stanislaw Barski - Limerick ME, US
Erwin Workman - Cape Elizabeth ME, US

International Classification:

G01N033/53
G01N033/542
C12M001/34

US Classification:

435/007900, 435/287200

Abstract:

Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a “generic capture” format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.

US Patent:

6436722, Aug 20, 2002

Filed:

Apr 18, 2000

Appl. No.:

09/551496

Inventors:

Scott M. Clark - Cape Elizabeth ME
Robert H. Suva - Windham ME
Michael R. Kepron - Standish ME
Stanislaw Barski, Jr. - Limerick ME

Assignee:

Idexx Laboratories, Inc. - Westbrook ME

International Classification:

G01N 33543

US Classification:

436518, 436 43, 436 55, 436169, 436178, 436512, 436524, 436527, 436528, 436536, 436541, 435 6, 435 71, 435 792, 435174, 435176, 435177, 4352871, 4352872, 4352873, 4352877, 4352881, 4352887, 422 50, 422 55, 422 56, 422 58, 422 63, 422 681, 422 83, 422 88, 422102, 422119, 422255, 422256, 422261, 422283, 422919, 422947

Abstract:

Invention performs an assay to determine presence or quantity of specific analyte in fluid sample. Representative device has two separate flow paths established sequentially in device with a single user activation step. First flow path delivers sample, and conjugate soluble binding reagents to solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. Sample volume delivered by first path determined by absorbent capacity of solid phase, and not by amount of sample added to device. User need not measure sample volume. Sample/conjugate mixture is prevented from entering second flow path because capillary and surface energy of second flow path prevent it from being wetted by this mixture. Second flow path allows wash reagent to remove unbound conjugate and sample from solid phase to the absorbant, and optionally deliver detection reagents. Adaptable for many formats including, sandwich immunoassays, colloidal gold, sol particle, heterogeneous generic capture, and competitive assays.