IP Library › Granted Patent US 7,772,007
Granted Patent B2
US 7,772,007 · App. 11/096,761 · Granted Aug 10, 2010

Assay device for direct measurement of LDL cholesterol

Assignee: Cholestech Corporation
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Quick Facts
Patent No.
US 7,772,007
App. No.
11/096,761
Granted
Aug 10, 2010
Kind
B2
Abstract

An assay device and method for measuring the concentration of LDL-associated cholesterol in a blood-fluid sample are described. The method employs selective precipitation of VLDL and chylomicrons and immunoseparation of HDL from a blood fluid sample. The assay device allows the assay to be performed entirely in a flow strip format.

Claims (59)

1. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area;

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample; and

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed, wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other.

2. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area;

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex, wherein said antibody element contains, in soluble form, a binding agent;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample, wherein said capture zone contains an immobilized capture agent, effective to bind said binding agent; and

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed, wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other.

3. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area;

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a

(2) material effective to remove such precipitated VLDL and chylomicrons from said sample;

(3) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex, wherein said antibody element contains, in soluble form, a biotin;

(4) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample, wherein said capture zone contains an immobilized avidin or streptavidin, effective to bind said biotin; and

(5) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed, wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other.

4. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area;

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex, wherein said antibody element contains, in soluble form, a binding agent;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample, wherein said capture zone contains an immobilized capture agent, effective to bind said binding agent; and

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed; wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other, wherein said mounting element is effective to bring said antibody element into fluid communication with said capture zone.

5. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area;

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex, wherein said antibody element contains, in soluble form, a binding agent;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample, wherein said capture zone contains an immobilized capture agent, effective to bind said binding agent;

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed, wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(5) a porous bridging element which can be brought into simultaneous contact with said antibody element and said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other, wherein said mounting element is effective to bring said antibody element into fluid communication with said capture zone.

6. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area; and

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample; and

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed; wherein said precipitation element is upstream of said antibody element or downstream of said capture zone; and

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other, wherein said mounting element is effective to bring said LDL test pad into or out of fluid communication with either said capture zone or said precipitation element, whichever is further downstream.

7. An assay device for the direct measurement of low-density lipoproteins (LDL) in a blood fluid sample also containing high density lipoproteins (HDL), very low density lipoproteins (VLDL), and/or chylomicrons, the device comprising:

(a) a sample loading area; and

(b) a plurality of porous elements through which said blood fluid sample can flow in sequence by capillary action and/or gravity, wherein adjacent elements are or can be placed in fluid communication with each other, said plurality comprising:

(1) a VLDL/chylomicron precipitation element, containing reagents effective to selectively precipitate VLDL and chylomicrons in said sample, and composed of a material effective to remove such precipitated VLDL and chylomicrons from said sample;

(2) an antibody element, containing an antibody effective to specifically bind HDL, thereby forming an HDL-antibody complex;

(3) a capture zone, wherein said HDL-antibody complex can be bound and thereby removed from said fluid sample; and

(4) an LDL test pad, downstream of said capture zone and said precipitation element, in which LDL concentration can be assayed; wherein said precipitation element is upstream of said antibody element or downstream of said capture zone;

(c) a mounting element effective to adjust the relative positions of said porous elements in such a way as to bring elements into or out of fluid communication with each other, wherein said mounting element is effective to bring said LDL test pad into or out of fluid communication with either said capture zone or said precipitation element, whichever is further downstream; and

(d) a reaction bar to which said LDL test pad is attached.

Assignments (9)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 11, 2012
From: CHOLESTECH CORPORATION
To: ALERE SAN DIEGO, INC
Reel/Frame 028349/0077 →
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 →
SECURITY AGREEMENT Recorded Oct 18, 2007
From: CHOLESTECH CORPORATION
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019974/0530 →
SECURITY AGREEMENT Recorded Oct 17, 2007
From: CHOLESTECH CORPORATION
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019974/0270 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2005
From: SHINDELMAN, JEFFREY; WORTHY, THOMAS E.; JONES, RONALD M.; WITHERS III, GEORGE E.
To: CHOLESTECH CORPORATION
Reel/Frame 016667/0433 →
Continuity (2)
Provisional Application 6055938200 · Apr 2, 2004
Related Publication 20050221502A1 · Oct 6, 2005