Diagnostic test kits employing an internal calibration system

• US 8,932,878 B2
• Filed: 03/31/2011
• Issued: 01/13/2015
• Est. Priority Date: 03/30/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Song, Xuedong, Chidebelu-Eze, Chibuese Obi, Kaylor, Rosann Marie Mathews
• Primary Examiner(s): Nguyen, Bao Thuy L
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US13/076,497
• Publication Number:
  US 20110177616A1
• Time in Patent Office: 1,384 Days
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]

Abstract

A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Claims

1. A method for quantitatively or semi-quantitatively detecting a test analyte within a test sample using a lateral flow device, the device comprising a porous membrane in communication with a calibration analyte, wherein the calibration analyte and the test analyte are distinct yet members of the same protein family, detection probes conjugated with a first specific binding member, and calibration probes conjugated with a second specific binding member, wherein the conjugated detection probes and conjugated calibration probes are applied to a conjugate pad, the porous membrane defining a detection zone on which is immobilized a first receptive material and a calibration zone on which is immobilized a second receptive material, the method comprising:

i) contacting the lateral flow device with the test sample, wherein the test analyte mixes with the calibration analyte;

ii) allowing the text analyte to bind to the detection probes to form test analyte/detection probe complexes and the calibration analyte to bind to the calibration probes to form calibration analyte/calibration probe complexes, wherein the test analyte/detection probe complexes travel to the detection zone and bind to the first receptive material and the calibration analyte calibration complexes travel to the calibration zone and bind to the second receptive material;

iii) measuring the intensity of a detection signal produced at the detection zone; and

iv) measuring the intensity of a calibration signal produced at the calibration zone, wherein the amount of the test analyte is directly proportional to the intensity of the detection signal as calibrated by the intensity of the calibration signal.

2. The method of claim 1, further comprising generating a calibration curve by plotting the ratio of the detection signal intensity to the calibration signal intensity for a plurality of predetermined analyte concentrations.

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

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

5. The method of claim 1, wherein the calibration analyte is pentraxin protein.

6. The method of claim 5, wherein the calibration analyte is a phosphocholine-binding pentraxin protein.

7. The method of claim 6, wherein the calibration analyte is pentraxin 3, neuronal pentraxin 1, or neuronal pentraxin 2.