Analytical test device for imuno assays and methods of using same

• US 6,352,862 B1
• Filed: 06/09/1997
• Issued: 03/05/2002
• Est. Priority Date: 02/17/1989
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Davis, Paul James, May, Keith, Prior, Michael Evans
• Primary Examiner(s): NGUYEN, BAO THUY L
• Assistant Examiner(s): Portner, Ginny Allen
• Application Number:
  US08/871,641
• Time in Patent Office: 1,730 Days
• Field of Search: 435/7-2-, 435/805, 435/806, 435/810, 435/970, 435/6, 436/518, 436/525, 436/528, 436/530, 436/541, 436/810, 436/814, 436/818, 422/101, 422/55
• US Class Current: 436/510
• 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 analytical test device suitable for analyzing a liquid sample suspected of containing an analyte, said device comprising the following separate components in sequential fluid communication:

(1) a liquid sample application member;

(2) a macroporous body positioned to receive liquid sample from said sample application member, said macroporous body including a mobilizable labeled specific binding reagent for binding to analyte in said sample; and

(3) a dry porous carrier strip downstream of said macroporous body, said carrier strip including a detection zone comprising an unlabeled immobilized specific binding reagent for binding to said analyte, said mobilizable labeled reagent being freely soluble or dispersible in liquid sample applied to the liquid application member and free to move therewith through the pores of said macroporous body whereby it is transported by said liquid sample from said macroporous body to said detection zone, said macroporous body and carrier strip comprising separate and different materials which overlap at their adjacent ends to provide effective contact between these components to ensure that liquid sample applied to said application member can permeate sequentially through the macroporous body and the carrier strip.

2. The analytical test device according to claim 1, wherein the dry porous carrier strip comprises a chromatographic strip.

3. The analytical test device according to claim 2, wherein the labelled specific binding reagent comprises a specific binding reagent attached to a particulate label.

4. The analytical test device according to claim 3, wherein the particulate label is latex.

5. The analytical test device according to claim 4, wherein the latex comprises particles having a maximum dimension of not greater than about 0.5 micron.

6. The analytical test device according to claim 4, wherein the latex is coloured.

7. The analytical test device according to claim 4, wherein the latex is fluorescent.

8. The analytical test device according to claim 1, wherein the macroporous body comprises plastics material.

9. The analytical test device according to claim 1, wherein the macroporous body has an average pore size of not less than 10 microns.

10. The analytical test device according to claim 3, wherein the macroporous body has a pore size not less than 10 times greater than the maximum particle size of the particulate label.

11. The analytical test device according to claim 1, wherein the porous dry carrier is nitrocellulose.

12. The analytical test device according to claim 11, wherein the nitrocellulose has a pore size of greater than about 1 micron.

13. The analytical test device according to claim 1, wherein the macroporous body is capable of absorbing at least as much of the liquid sample as can be absorbed by the dry porous carrier linking the macroporous body and the detection zone.

14. The analytical test device according to claim 1 wherein the macroporous body and porous carrier are contained within a casing constructed of moisture-impermeable material and the means for applying sample to said macroporous body comprises a sample entry port communicating with the macroporous body, the casing or housing also incorporating means to enable the detection zone to be observable from outside the casing or housing.

15. The analytical device according to claim 1, wherein the porous carrier is linked via the macroporous body to a porous receiving member to which the liquid sample can be applied and from which the sample can permeate into the porous carrier.

16. The analytical device according to claim 15, wherein the porous carrier and the macroporous body are contained within a casing or housing constructed of moisture-impermeable material and the porous receiving member extends out of the casing or housing and can act as a means for permitting a liquid sample to enter the housing and reach the porous carrier, the casing or housing being provided with means which enable the detection zone of the porous carrier to be observable from outside the casing or housing so that the result of the assay can be observed.

17. The analytical device according to claim 16, wherein the casing is provided with means which enable a further zone of the porous carrier to be observed from outside the housing and which further zone incorporates mean which enable an indication to be given as to whether an assay procedure has been completed.

18. The analytical device according to claim 16, comprising a removable cap or shroud which can protect the protruding porous receiving member during storage before use.

19. The analytical test device of claim 1 which comprises a further zone downstream of said detection zone to indicate completion of the assay procedure.

20. A pregnancy testing device for detecting hCG antigen in a urine sample comprising a hollow elongated casing containing a dry porous nitrocellulose carrier which communicates indirectly with the exterior of the casing via a bibulous urine receiving member which protrudes from the casing, the porous nitrocellulose carrier and the sample receiving member being linked via a macroporous body which is different from the dry porous carrier such that any urine sample reaching the porous carrier must first pass through the macroporous body, the sample receiving member and the macroporous body together acting as a reservoir from which urine is released into the porous carrier, the macroporous body containing a specific anti-hCG antibody bearing a coloured particulate label, the labelled antibody being freely mobile within the macroporous body and the porous carrier when in the moist state, and in a detection zone on the carrier spatially distant from the macroporous body a specific unlabelled anti-hCG antibody which is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the labelled and unlabelled antibodies having specificities for different hCG epitopes, the casing being constructed of opaque or translucent material incorporating at least one aperture through which the analytical result may be observed, together with a removable and replaceable cover for the protruding bibulous urine receiving member, said nitrocellulose carrier and macroporous body overlapping at their adjacent ends to provide effective contact between these components to ensure that liquid sample applied to said application member can permeate sequentially through the macroporous body and the carrier strip.

21. A testing device for detecting LH antigen in a urine sample comprising a hollow elongated casing containing a dry porous nitrocellulose carrier which communicates indirectly with the exterior of the casing via a bibulous urine receiving member which protrudes from the casing, the porous nitrocellulose carrier and the sample receiving member being linked via a macroporous body which is different from the dry porous carrier such that any urine sample reaching the porous carrier must first pass through the macroporous body, the sample receiving member and the macroporous body together acting as a reservoir from which urine is released into the porous carrier, the macroporous body containing a specific anti-LH antibody bearing a coloured particulate label, the labelled antibody being freely mobile within the macroporous body and the porous carrier when in the moist state, and in a detection zone on the carrier spatially distant from the macroporous body a specific unlabelled anti-LH antibody which is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the labelled and unlabelled antibodies having specificities for different LH epitopes, the casing being constructed of opaque or translucent material incorporating at least one aperture through which the analytical result may be observed, together with a removable and replaceable cover for the protruding bibulous urine receiving member, said nitrocellulose carrier and macroporous body overlapping at their adjacent ends to provide effective contact between these components to ensure that liquid sample applied to said application member can permeate sequentially through the macroporous body and the carrier strip.