Assay devices

• US 6,156,271 A
• Filed: 02/17/1998
• Issued: 12/05/2000
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: May, Keith
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/025,108
• Time in Patent Office: 1,022 Days
• Field of Search: 422/56, 422/58, 422/61, 436/169, 436/175, 436/177-178, 436/808, 436/814, 436/906
• US Class Current: 422/412
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

An assay device incorporates a composite strip comprising at least two bodies of porous liquid-conductive material in liquid-flow contact with each other via an interface and together defining at least part of a liquid flow path through which liquid must flow during the performance of an assay, wherein at said interface the lateral dimension, relative to the direction of the liquid flow path, of the contact area of the upstream body is narrowed such that liquid flow from the upstream body into the downstream body is focused towards the centre-line of the flow path in the downstream body, thereby reducing the likelihood that liquid will deviate from the intended flow path. The upstream body can be a sample-collecting wick, terminating at the interface as a point or prow (FIG. 7).

Claims

1. An assay device incorporating a composite strip comprising at least two bodies of porous liquid-conductive material so as to provide an upstream body and a downstream body in liquid-flow contact with each other via an interface and together defining at least part of a liquid flow path through which liquid must flow during the performance of an assay, wherein at said interface the lateral dimension, relative to the direction of said liquid flow path, of the contact area of the upstream body is narrowed such that liquid flow from said upstream body into the downstream body is focused towards the centre-line of said flow path in said downstream body, the upstream body being narrowed at said interface by at least 50% of its width to provide a narrowed point or prow on the centre-line of said flow path for contact with said downstream body, said narrowed point or prow of the upstream body overlapping with the downstream body to provide the interface for contact between the upstream body and said downstream body whereby deviation from the intended flow path is reduced.

2. An assay device according to claim 1, wherein said upstream body incorporates a mobilisable reagent upstream from said narrowed portion of said porous body.

3. An assay device according to claim 1, which can detect the presence or concentration of at least two different analytes in a single sample applied to said assay device.

4. An assay device according to claim 3, which can detect in a single applied urine sample both E3G and LH.

5. An assay device according to claim 1, wherein said bodies of porous material are contained at least partially within a hollow casing constructed of solid moisture-impervious material.

6. An assay device according to claim 1 or claim 5, wherein said bodies of porous material are physically separate components and are placed in contact with one another during assembly of said device.

7. An assay device according to claim 5, wherein said bodies of porous material are physically separate components and are held in contact with one another solely by being constrained within said hollow casing.

8. An assay device according to any claim 1, wherein said upstream body is a sample receiving member or wick.

9. An assay device according to claim 8, wherein said bodies of porous material are contained at least partially within a hollow casing constructed of solid moisture-impervious material, and said sample receiving member or wick protrudes from said casing but the portion of said sample receiving member or wick which is narrowed is within said casing.

10. An assay device according to claim 8 or claim 9, wherein said sample receiving member or wick is made from non-woven fabric.

11. An assay device according to claim 8 or claim 9, wherein said sample receiving member or wick is made from fibrous plastics material.

12. An assay device, according to claim 9 wherein said wick comprises a strip of porous material having at one end thereof a narrowed point or prow centred on the longitudinal axis of said strip.

13. An assay device according to claim 12, in which said narrowed portion extends over not more than 35% of the overall length of said wick.

14. An assay device incorporating a composite strip comprising at least two bodies of porous liquid-conductive material in liquid-flow contact with each other via an interface and together defining at least part of a liquid flow path through which liquid must flow during the performance of an assay, wherein at said interface the lateral dimension, relative to the direction of said liquid flow path, of the contact area of the upstream body is narrowed such that liquid flow from said upstream body into the downstream body is focused towards the centre-line of said flow path in said downstream body, both said upstream and downstream bodies including reagents for said assay, the upstream body incorporating a mobilizable reagent upstream from said narrowed portion, the narrowed area of the upstream body overlapping with the downstream body to provide the interface for contact between the upstream body and said downstream body whereby deviation from the intended flow path is reduced.