Diagnostic test kits with improved detection accuracy

• US 7,829,347 B2
• Filed: 08/31/2005
• Issued: 11/09/2010
• Est. Priority Date: 08/31/2005
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Song, Xuedong
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/217,112
• Publication Number:
  US 20070048807A1
• Time in Patent Office: 1,896 Days
• Field of Search: 435/7.1, 435/7.92, 435/7.2, 435/2, 435/5, 435/7.21, 435/7.32, 435/239, 435/803, 435/805, 435/287.2, 435/287.9, 435/970, 436/512, 436/513, 436/518, 436/514, 436/531, 436/526, 436/533, 436/538, 436/806, 436/824, 422/56, 422/58, 422/61
• US Class Current: 436/518
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/803 Physical recovery methods, e.g. chromatography, grinding
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property
• CPC Class Codes: Y10S 436/824 Immunological separation techniques

Abstract

A diagnostic test kit that provides an integrated system for accurately detecting a test analyte over a broad range of possible concentrations is provided. One feature of the integrated system is that it is capable of indicating whether an analyte is within the “hook effect” region. Based on this indication, a technique may be selected for correlating a measured signal intensity to an analyte concentration or range of concentrations. For example, when it is determined that the test sample falls outside the “hook effect” region, the analyte concentration may be determined using one portion of a dose response curve. On the other hand, when it is determined that the test sample falls within the “hook effect” concentration, the analyte concentration may be determined using another portion of the dose response curve. Alternatively, the sample may simply be diluted for re-performing the assay. Regardless of whether the test sample is within or outside of the “hook effect” concentration, another feature of the integrated detection system of the present invention is that it is internally calibrated to provide a more accurate quantitative or semi-quantitative result to a user.

Claims

1. A diagnostic test kit for detecting the presence or quantity of a test analyte within a test sample, the diagnostic test kit comprising:

detection probes conjugated with a first specific binding member that is configured to preferentially bind to the test analyte;

calibration probes conjugated with a second specific binding member that is configured to preferentially bind to a calibration analyte; and

a lateral flow assay device on which the detection probes and calibration probes are disposed, the lateral flow assay device comprising a porous membrane, the porous membrane defining;

a detection zone in which is immobilized a first receptive material, the first receptive material being configured to preferentially bind to the test analyte;

an indicator zone in which is immobilized a second receptive material, the second receptive material being configured to preferentially bind to uncomplexed conjugated detection probes; and

a calibration zone in which is immobilized a third receptive material, the third receptive material being configured to preferentially bind to the calibration analyte;

wherein the lateral flow device further comprising a conjugate pad in fluid communication with the porous membrane and a sample pad that is positioned upstream from the conjugate pad, wherein the detection probes and calibration probes are disposed on the conjugate pad and wherein the calibration analyte is disposed on the sample pad.

2. The diagnostic test kit of claim 1, wherein the detection probes comprise a luminescent compound or visual label.

3. The diagnostic test kit of claim 1, wherein the test analyte is a pentraxin protein.

4. The diagnostic test kit of claim 3, wherein the test analyte is C-reactive protein.

5. The diagnostic test kit of claim 1, wherein the calibration analyte and the test analyte are members of the same protein family.

6. The diagnostic test kit of claim 1, wherein the calibration analyte and the test analyte are members of different protein families.

7. The diagnostic test kit of claim 1, wherein the first and second specific binding members are selected from the group consisting of antibodies, antigens, haptens, protein A, protein G, protein A/G, neutravidin, avidin, streptavidin, captavidin, and analogs thereof.

8. The diagnostic test kit of claim 1, wherein the first, second, and third receptive materials are selected from the group consisting of antibodies, antigens, haptens, protein A, protein G, protein A/G, neutravidin, avidin, streptavidin, captavidin, and analogs thereof.

9. The diagnostic test kit of claim 1, wherein the second receptive material has at least one epitope in common with the test analyte.

10. The diagnostic test kit of claim 9, wherein the second receptive material includes an antigen or an analog thereof.

11. The diagnostic test kit of claim 1, wherein the first receptive material includes an antibody or an analog thereof.

12. The diagnostic test kit of claim 1, wherein the detection zone is located upstream from the indicator zone.

13. The diagnostic test kit of claim 1, wherein the calibration zone is located downstream from the detection zone.

14. The diagnostic test kit of claim 1, wherein the calibration zone is located upstream from the detection zone.

15. The diagnostic test kit of claim 1, wherein the concentration of the analyte is determined by reference to an indicator signal produced by the indicator zone and a detection signal produced by the detection zone, one or both of which are calibrated by a calibration signal produced by the calibration zone.

16. The diagnostic test kit of claim 15, wherein the intensity of the indicator signal is indicative of whether the concentration of the analyte within the test sample is within the hook effect region.

17. The diagnostic test kit of claim 1, wherein the first specific binding member, the second specific binding member, the first receptive material, and the second receptive material are immunoreactive binding members.