Methods for monitoring the status of assays and immunoassays

• US 6,194,222 B1
• Filed: 01/05/1998
• Issued: 02/27/2001
• Est. Priority Date: 01/05/1998
• Status: Expired due to Term

• Current Assignee: Quidel Cardiovascular, Inc. (Quidel Corporation)
• Original Assignee: Biosite Diagnostics Incorporated (Abbott Laboratories)
• Inventors: Buechler, Kenneth F., McPherson, Paul H., Anderberg, Joseph M
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Cook, Lisa V.
• Application Number:
  US09/003,065
• Time in Patent Office: 1,149 Days
• Field of Search: 436/514, 436/530, 436/810, 436/541, 436/162, 436/904, 436/166, 436/169, 436/170, 436/510, 435/7, 435/4, 435/25, 435/28, 435/805, 435/7.21, 435/7.94, 435/69.2, 435/184, 435/518, 435/14, 422/57, 422/101, 422/56, 422/58
• US Class Current: 436/518
• CPC Class Codes: G01N 11/04 through a restricted passage, e.g. tube, aperture
• CPC Class Codes: G01N 2011/008 optical properties
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 2035/00702 Curve-fitting; Parameter matching; Calibration constants
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 35/00693 Calibration
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/967 Standards, controls, materials, e.g. validation studies, buffer systems
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/971 Capture of complex after antigen-antibody reaction
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin

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

1. A method for determining a rate of flow of a solution through an assay device, wherein said assay device during an assay for a predetermined analyte comprises a reaction chamber and at least one diagnostic lane, the method comprising:

(a) providing a first member of a binding pair (MBP) in said reaction chamber and a second MBP bound to a solid phase on said diagnostic lane, wherein said first MBP comprises a label, wherein said first MBP and said second MBP do not bind to any analyte or to any reagents used for measuring the presence or amount of any analyte in said assay device during the assay for the predetermined analyte, and wherein said first MBP and said second MBP have specific binding affinity for one another;

(b) detecting a signal from said diagnostic lane, wherein said signal is generated from said label; and

(c) determining said rate of flow of liquid through said assay device during an assay for a predetermined analyte from said reaction chamber through said diagnostic lane from the amount of said signal in said diagnostic lane.

2. The method of claim 1, comprising the step of correcting an assay measurement by utilizing said signal.

3. The method of claim 1, wherein said first MBP and said second MBP are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

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

5. The method 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.

6. A method for determining the effect of a physical parameter in an assay device or of a fluid introduced into the assay device during an assay for a predetermined analyte, wherein said assay device comprises a reaction chamber and at least one diagnostic lane, the method comprising:

(a) providing a first MBP comprising a label and a second MBP comprising an affinity tag in said reaction chamber, said first MBP and said second MBP arranged to form a solution with a test sample, and providing an affinity tag partner on said diagnostic lane, wherein said affinity tag partner has specific binding affinity for said affinity tag, wherein said first MBP, said second MBP, said affinity tag partner, and said affinity tag do not bind to any analyte, or to any reagents used for measuring, the presence or amount of any analyte in said assay device, during an assay for a predetermined analyte and wherein said first MBP and said second MBP have specific binding affinity for one another;

(b) detecting a signal from said diagnostic lane, wherein said signal is generated from said label, wherein said signal is detected at a location [in a position] wherein said affinity tag partner is located; and

(c) determining the effect of the physical parameter in the assay device or of the fluid introduced into the assay device during the assay for the predetermined analyte, wherein said physical parameters is related to the amount of said signal in said diagnostic lane.

7. The method of claim 6, comprising the step of correcting an assay measurement by utilizing said signal.

8. The method of claim 6, wherein said first MBP and said second MBP are associated with at least one of a lid and base of said reaction chamber.

9. The method of claim 6, wherein said affinity tag partner is associated with a solid support in said diagnostic lane.

10. The method of claim 6, comprising the step of introducing said second MBP and said affinity tag partner to said reaction chamber, wherein said affinity tag partner comprises a second affinity tag, wherein said diagnostic lane comprises a second affinity tag partner, wherein said second affinity tag partner has specific binding affinity for said second affinity tag, and wherein said second affinity tag partner and said second affinity tag do not appreciably bind to said assay reagents.

11. The method of claim 6, wherein said first MBP and said second MBP are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

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

13. The method of claim 6, 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.

14. A method for measuring progress and time of completion for an assay in an assay device during an assay for a predetermined analyte, wherein said assay device comprises a reaction chamber and at least one diagnostic lane:

(a) providing a label in said reaction chamber, wherein said label does not bind to any reagents used for measuring the presence or amount of any analyte in said assay device during an assay for a predetermined analyte,

(b) detecting a signal from at least one discrete zone of said diagnostic lane, wherein said signal is generated from said label, and wherein said zone does not bind any analyte, or any reagents used for measuring the presence or amount of any analyte in said assay device during an assay for a predetermined analyte, and

(c) determining said progress and time of completion of said assay in said assay device from at least one of;

(i) a rate of change of the amount of said signal; and

(ii) an absolute amount of said signal.

15. The method of claim 14, comprising the step of correcting an assay measurement by utilizing said signal.

16. The method of claim 14, wherein said label is linked to a member of a binding pair (MBP).

17. The method of claim 14, wherein the derivative of said rate of change of the amount of said signal is determined.

18. The method of claim 14, wherein said rate of change is a negative rate of change of the amount of said signal.

19. The method of claim 14, wherein said absolute amount of said signal is averaged.

20. The method of claim 14, wherein said MBP is selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

21. The method of claim 14, wherein said reagents are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

22. The method of claim 14, 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.

23. A method for verifying a location of a detection zone in an assay device, wherein said assay device during an assay for a predetermined analyte, comprises a reaction chamber and at least one diagnostic lane, the method comprising:

(a) providing a label in said reaction chamber, wherein said label does not bind to any analyte or to any reagents used for measuring the presence or amount of any analyte in said assay device during an assay for a predetermined analyte,

(b) measuring a signal from at least one discrete zone of said diagnostic lane, wherein said signal is generated by said label; and

(c) verifying said location of said detection zone by a detection of said signal in said discrete zone of said diagnostic lane.

24. The method of claim 23, comprising the step of correcting an assay measurement by utilizing said signal.

25. The method of claim 23, wherein said label is linked to a member of a binding pair (MBP).

26. The method of claim 25, wherein said MBP is selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

27. The method of claim 23, wherein said reagents are selected from the group consisting of binding protein, antibody, antibody fragment, protein, peptide, and organic molecule.

28. The method of claim 23, 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.