Extension of the dynamic detection range of assay devices

• US 7,943,395 B2
• Filed: 11/21/2003
• Issued: 05/17/2011
• Est. Priority Date: 11/21/2003
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Wei, Ning, Boga, Rameshbabu
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US10/718,997
• Publication Number:
  US 20050112779A1
• Time in Patent Office: 2,734 Days
• Field of Search: 422/55, 422/56, 422/61, 422/68.1, 422/82.05, 435/4, 435/7.1, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/288.7, 436/501, 436/518, 436/528, 436/164, 436/169, 436/172, 436/807
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• 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: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes multiple detection zones, one of which is premised on “competitive” binding of the analyte and the other is premised on “sandwich” binding of the analyte. The present inventors believe that the combination of these zones may enable the detection of an analyte over extended concentration ranges.

Claims

1. A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a porous membrane in communication with optical detection probes conjugated with a first antibody specific for the analyte, said porous membrane defining:

a competitive zone that contains a second antibody immobilized on said porous membrane that is complexed to an antigen containing an optically detectable substance prior to the application of a test sample to the device, said antigen being identical to or an analog of the analyte and said optically detectable substance being capable of producing a competitive signal when contained within said competitive zone; and

a detection zone within which a third antibody is immobilized that is configured to bind to complexes formed between the analyte and said conjugated optical detection probes to produce a first detection signal, said third antibody also being configured to bind to said antigen from said competitive zone to produce a second detection signal, wherein the amount of the analyte within the test sample is determined from said competitive signal, and at least one of said first detection signal and said second detection signal.

2. A flow-through assay device as defined in claim 1, wherein said optical detection probes and said optically detectable substance of said antigen each comprise a visual label.

3. A flow-through assay device as defined in claim 1, wherein said optical detection probes and said optically detectable substance of said antigen each comprise a luminescent compound.

4. A flow-through assay device as defined in claim 3, wherein said detection probes emit a signal at a different wavelength than said optically detectable substance of said antigen.

5. A flow-through assay device as defined in claim 1, wherein said porous membrane further defines a calibration zone that is configured to produce a calibration signal.

6. A flow-through assay device as defined in claim 1, wherein the amount of the analyte within the test sample is capable of being determined from one or both of the following formulae:

D₁+x,

when x>

0, D₁=D_1max

wherein,

x=C_1max−

C₁;

C_1max is a predetermined maximum intensity for said competitive signal;

C₁ is the intensity of said competitive signal;

D₁ is the intensity of said first detection signal; and

D_1max is a predetermined maximum intensity for said first detection signal;

or

D₁+D₂,

when D₂>

0, D₁=D_1max

wherein,

D₁ is the intensity of said first detection signal;

D_1max is a predetermined maximum intensity for said first detection signal; and

D₂ is the intensity of said second detection signal.

7. A flow-through assay device as defined in claim 1, wherein the intensity of the competitive signal is at a maximum value when no analyte is present within the test sample.

8. A flow-through assay device as defined in claim 1, wherein the conjugated detection probes bind to the antigen within the competitive zone to produce a second competitive signal when no analyte is present within the test sample.

9. A flow-through assay device as defined in claim 1, wherein the intensity of the first detection signal reaches a maximum value at or near the saturation concentration of the analyte within the test sample.