IP Library › Granted Patent US 7,425,302
Granted Patent B2
US 7,425,302 · App. 10/784,155 · Granted Sep 16, 2008

Dry chemistry, lateral flow-reconstituted chromatographic enzyme-driven assays

Assignee: Binax, Inc.
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Quick Facts
Patent No.
US 7,425,302
App. No.
10/784,155
Granted
Sep 16, 2008
Kind
B2
Abstract

A lateral flow chromatographic assay format for the performance of rapid enzyme-driven assays is described. A combination of components necessary to elicit a specific enzyme reaction, which are either absent from the intended sample or insufficiently present therein to permit completion of the desired reaction, are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final “read zone” wherein the color developed is read against predetermined color standards for the desired reaction. Pretreatment pads for the sample, as needed, (e.g. a lysing pad for lysing red blood cells in whole blood) are placed in front of the sample pad in the flow path as appropriate. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays. Specific assays for glucose-6-phosphate dehydrogenase (“G-6PD”), total serum cholesterol, β-lactamase activity and peroxidase activity are disclosed.

Claims (7)

1. A chromatographic strip comprising at least a first and a second pad in fluid communication and positioned on an adhesive backing, wherein

(1) the first is a sample receiving pad adapted to receive a blood sample which flows laterally and chromatographically through the sample receiving pad, wherein the sample receiving pad allows said blood sample to flow chromatographically into a substrate pad; and

(2) the second pad is a substrate pad on which has been deposited within an area near its interface with the sample receiving pad a mobilizable dry mixture of components including a substrate for the enzyme glucose-6-phosphate dehydrogenase (G6PD), which components, when reconstituted by chromatographic lateral flow of the blood sample perform an enzyme-driven assay for G6PD activity on the blood sample.

2. The chromatographic strip according to claim 1 , wherein a region of the sample receiving pad has been pretreated to remove from, or reduce the concentration in the blood sample as it flows therethrough of a substance known to interfere with, obscure the result of or otherwise hinder the performance of the enzyme-driven assay for G6PD activity if present therein.

3. The chromatographic strip according to claim 1 , wherein a region of the sample receiving pad has been treated to concentrate the blood sample as it flows therethrough by removing a portion of its liquid content.

4. The chromatographic strip according to claim 1 , wherein an intermediate pad is interposed between the sample receiving pad and the substrate pad and said intermediate pad has been treated with an immovable deposit of at least one substance that removes and binds at least one sample component that would otherwise interfere with or obscure the result of the enzyme-driven assay for G6PD activity.

5. The chromatographic strip according to claim 1 , wherein the sample receiving pad is adapted to receive a lysing agent.

Assignments (11)
CHANGE OF NAME Recorded Jan 8, 2020
From: ALERE SCARBOROUGH, INC.
To: ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
Reel/Frame 051505/0794 →
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 036994, FRAME 0192 AND REEL 037115, FRAME 0498 Recorded Oct 5, 2017
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS COLLATERAL AGENT
To: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
Reel/Frame 044213/0258 →
ASSIGNMENT OF IP SECURITY AGREEMENT, PREVIOUSLY RECORDED AT REEL 036994, FRAME 0192 Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING ADMINISTRATIVE AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR ADMINISTRATIVE AGENT
Reel/Frame 037115/0498 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Oct 29, 2015
From: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 036994/0192 →
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 026557 FRAME 0287 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL, INC.; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; MATRIA HEALTHCARE, INC.; ZYCARE, INC.
Reel/Frame 036011/0581 →
CHANGE OF NAME Recorded Aug 26, 2011
From: BINAX, INC.
To: ALERE SCARBOROUGH, INC.
Reel/Frame 026817/0588 →
SECURITY AGREEMENT Recorded Jul 7, 2011
From: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL INCORPORATED; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; ZYCARE INC.; MARTIA HEALTHCARE, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026557/0287 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 27, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; WAMPOLE LABORATORIES, LLC, A DELAWARE LIMITED LIABILITY COMPANY
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019477/0808 →
FIRST LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 26, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019477/0268 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2007
From: PIASIO, ROGER N.; TURNER, NATHAN
To: BINAX, INC.
Reel/Frame 018912/0773 →
SECURITY AGREEMENT Recorded May 11, 2005
From: BINAX, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 016561/0835 →
Continuity (2)
Continuation In Part 1037057400 · Feb 24, 2003
Related Publication 20040203086A1 · Oct 14, 2004