IP Library › Granted Patent US 7,713,703
Granted Patent B1
US 7,713,703 · App. 09/712,615 · Granted May 11, 2010

Methods for monitoring the status of assays and immunoassays

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Quick Facts
Patent No.
US 7,713,703
App. No.
09/712,615
Granted
May 11, 2010
Kind
B1
Abstract

The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.

Claims (35)

1. An apparatus for measuring progress and time of completion of an assay in an assay device, comprising:

(a) said assay device comprising

a reaction chamber and

at least one diagnostic lane, wherein a label is provided in said reaction chamber;

(b) an optical component for detecting a signal generated from said label in at least one discrete zone of said diagnostic lane; and

(c) a signal processor for determining said progress and time of completion of said assay in said assay device from at least one parameter selected from the group consisting of a rate of change of the amount of said signal and an absolute amount of said signal;

wherein the label does not appreciably bind to assay reagents in said assay device.

2. A kit for measuring progress and time of completion of an assay in an assay device, comprising:

(a) instructions comprising text or diagrams about the apparatus and/or kit; and

(b) an apparatus, comprising:

(i) said assay device comprising

a reaction chamber and

at least one diagnostic lane, wherein a label is provided in said reaction chamber;

(ii) an optical component for detecting a signal generated from said label in at least one discrete zone of said diagnostic lane; and

(iii) a signal processor for determining said progress and time of completion of said assay in said assay device from at least one parameter selected from the group consisting of a rate of change of the amount of said signal and an absolute amount of said signal;

wherein the label does not appreciably bind to assay reagents in said assay device.

3. An apparatus for measuring progress and time of completion of an assay in an assay device, comprising:

(a) said assay device comprising

a reaction chamber, and

at least one diagnostic lane, wherein said diagnostic lane is in fluid communication with said reaction chamber when fluid and a detectable label are added to said reaction chamber;

(b) an optical component for detecting a signal generated from said label in at least one discrete zone of said diagnostic lane; and

(c) a signal processor for determining said progress and time of completion of said assay in said assay device from at least one parameter selected from the group consisting of a rate of change of the amount of said signal and an absolute amount of said signal;

wherein the label does not appreciably bind to assay reagents in said assay device.

4. The apparatus of claim 1 , wherein said label is linked to a member of a binding pair.

5. The apparatus of claim 4 , wherein the member of a binding pair is selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

6. The apparatus of claim 1 , wherein said assay reagents are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

7. The apparatus of claim 1 , wherein said label is selected from the group of molecules consisting of dye, fluorescence emitting dye, chemiluminescence emitting dye, infrared emitting dye, colloidal sol, molecule that generates an electrical and/or magnetic signal, and enzyme.

8. The kit of claim 2 , wherein said label is linked to a member of a binding pair.

9. The kit of claim 8 , wherein the member of a binding pair is selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

10. The kit of claim 2 , wherein said label is selected from the group of molecules consisting of dye, fluorescence emitting dye, chemiluminescence emitting dye, infrared emitting dye, colloidal sol, molecule that generates an electrical and/or magnetic signal, and enzyme.

11. The kit of claim 2 , wherein said assay reagents are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

12. The apparatus of claim 3 , wherein said label is linked to a member of a binding pair.

13. The apparatus of claim 12 , wherein the member of a binding pair is selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

14. The apparatus of claim 3 , wherein said label is selected from the group of molecules consisting of dye, fluorescence emitting dye, chemiluminescence emitting dye, infrared emitting dye, colloidal sol, molecule that generates an electrical and/or magnetic signal, and enzyme.

15. The apparatus of claim 3 , wherein said assay reagents are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

Assignments (12)
RELEASE OF SECURITY INTEREST Recorded May 31, 2022
From: BANK OF AMERICA, N.A.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 060052/0786 →
TRIAGE ASSIGNMENT, ASSUMPTION AND BILL OF SALE Recorded Oct 24, 2017
From: ALERE SAN DIEGO, INC.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 044281/0152 →
SECURITY INTEREST Recorded Oct 6, 2017
From: QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 043803/0359 →
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 →
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 Jul 6, 2007
From: BIOSITE INCORPORATED
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019523/0276 →
SECURITY AGREEMENT Recorded Jul 5, 2007
From: BIOSITE INCORPORATED
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019519/0929 →
CHANGE OF NAME Recorded Jun 9, 2003
From: BIOSITE DIAGNOSTICS, INC.
To: BIOSITE, INC.
Reel/Frame 013718/0091 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2003
From: BIOSITE DIAGNOSTICS, INC.
To: BIOSITE, INC.
Reel/Frame 013718/0095 →