Assays

• US 7,384,796 B2
• Filed: 12/23/2002
• Issued: 06/10/2008
• Est. Priority Date: 02/17/1989
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Davis, Paul James, May, Keith, Prior, Michael Evans
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): DiRamio; Jacqueline A.
• Application Number:
  US10/328,403
• Publication Number:
  US 20030219908A1
• Time in Patent Office: 1,996 Days
• Field of Search: 436/514, 435/805, 435/810, 435/970, 435/4, 435/7.1, 435/287.1, 435/287.7, 435/288.7, 422/50, 422/57, 422/58, 422/68.1, 422/99, 422/104
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54386 Analytical elements
• 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: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/806 Fertility tests
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/814 Pregnancy
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin

Abstract

An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.

Claims

1. An immunoassay method performed using an immunoassay test strip, the method comprising:

contacting a liquid sample with a porous receiving member of the test strip, the liquid sample comprising an analyte,

flowing the liquid sample along the porous receiving member and thereafter into a macroporous body of the test strip, the macroporous body comprising, in a dried state, a labeled binding reagent comprising a colored particle and a binding portion capable of binding the analyte,

flowing the liquid applied to the macroporous body therealong,

mobilizing, with the liquid flowing along the macroporous body, the labeled binding reagent from the dried state within the macroporous body,

flowing the liquid that comprises the mobilized labeled binding reagent into a location of a porous strip of the test strip, the porous strip comprising a detection zone,

flowing the liquid applied to the porous strip along the porous strip to the detection zone of the porous strip, and

immobilizing, in the detection zone, a colored complex, the colored complex comprising the labeled binding reagent, the analyte, and a first binding reagent immobilized in the detection zone, the labeled binding reagent and the first binding reagent bound to the analyte.

2. The immunoassay method of claim 1, wherein the porous strip is a nitrocellulose strip.

3. The immunoassay method of claim 2, wherein the analyte is a gonadotropin compound.

4. The immunoassay method of claim 3, wherein the colored particle is a latex particle.

5. The immunoassay method of claim 2, comprising specifically binding the first binding reagent and the analyte.

6. The immunoassay method of claim 5, wherein the device comprises a housing formed of impermeable material and flowing the liquid sample along the porous receiving member comprises flowing the liquid sample from an exterior of the housing to an interior of the housing.

7. The immunoassay method of claim 1, wherein the device comprises a housing formed of impermeable material and flowing the liquid sample along the porous receiving member comprises flowing the liquid sample from an exterior of the housing to an interior of the housing.

8. The immunoassay method of claim 2 further comprising detecting, with an instrument, the presence of the colored product in the detection zone.

9. The immunoassay method of claim 1, wherein contacting the liquid sample comprises receiving a urine stream with the porous receiving member exposed to the urine stream.

10. The immunoassay method of claim 1, wherein the porous receiving member and the macroporous body are offset and partially overlapping.

11. The immunoassay method of claim 1, wherein the porous receiving member and the macroporous body are partially overlapping.

12. The method of claim 11, wherein the porous strip is nitrocellulose.

13. The method of claim 7, wherein the porous strip is nitrocellulose.

14. The method of claim 8, wherein the porous strip is nitrocellulose.

15. An immunoassay method performed using an immunoassay test strip, the method comprising:

contacting a liquid sample with a porous receiving member of the immunoassay test strip, the liquid sample suspected of comprising human chronic gonadotrophin (hCG),

flowing the liquid sample along the porous receiving member and thereafter into a macroporous body of the test strip, the macroporous body comprising, in a dried state, a labeled binding reagent comprising a colored particle and a binding portion capable of hCG,

flowing the liquid applied to the macroporous body therealong,

mobilizing, with the liquid flowing along the macroporous body, the labeled binding reagent from the dried state within the macroporous body,

flowing the liquid that comprises the mobilized labeled binding reagent into a location of a porous strip of the test strip, the porous strip comprising a detection zone,

flowing the liquid applied to the porous strip along the porous strip to the detection zone of the porous strip, and

immobilizing, in the detection zone, a colored complex, the colored complex comprising the labeled binding reagent, hCG, and thea first binding reagent immobilized in the detection zone, the labeled binding reagent and the first binding reagent bound to the hCG.