Assay device

• US 6,399,398 B1
• Filed: 09/22/1995
• Issued: 06/04/2002
• Est. Priority Date: 09/23/1994
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unipath Limited (Abbott Laboratories)
• Inventors: Cunningham, Carole R, Wilson, Stewart J
• Primary Examiner(s): Nguyen, Bao-Thuy L.
• Application Number:
  US08/533,075
• Time in Patent Office: 2,447 Days
• Field of Search: 424/446, 435/7.2, 435/4, 435/287.7, 435/287.9, 435/805, 435/970, 436/510, 436/534, 436/518, 436/530, 436/63, 436/65, 436/810, 436/814, 436/533, 422/56, 422/57, 422/58
• US Class Current: 436/534
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/805 Test papers
• 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

Abstract

An assay device comprises a sample-collecting wick made from non-woven fabric material laminated to plastics sheet. Preferably, the fabric is a 30:70 blend of viscose and polyester, and has a fibrous structure in which more than two thirds of the fibers run substantially parallel to the intended direction of liquid flow in the wick.

Claims

1. An assay device for assaying a liquid sample, said device consisting essentially of:

a) an assay strip including one or more detection zones within which a result of said assay is revealed by an accumulation therein of a detectable reagent; and

b) a sample receiving member to act as a reservoir of sample liquid which feeds progressively into an end of said strip, said sample receiving member incorporating said detectable reagent in a dry state and wherein said detectable reagent becomes mobile under influence of received sample liquid and is carried thereby from said sample receiving member to said one or more detection zones of said assay strip;

said sample receiving member consisting essentially of a single layer of hydrophilic non-woven fabric material which has a liquid capacity exceeding the capacity of the assay strip and any sink at the distal end of the strip and which permits the sample liquid to move said reagent to the detection zone, said non-woven fabric material having a weight of at least about 50 g/m³ and consisting essentially of fibres of which some lie parallel to a flow direction in which applied liquid sample must flow along said sample receiving member into said assay strip and others of said fibres lie orthogonal to said flow direction, in a numerical ratio of flow-parallel fibres to flow-orthogonal fibres of at least 2;

1;

wherein, release of said dried detectable reagent is enhanced by said sample receiving member, and said assay strip and receiving member overlapping at adjacent ends thereof to further facilitate flow of sample liquid from said receiving member through said strip.

2. The device according to claim 1, in which said non-woven fabric material is a blend of viscose and polyester.

3. The device according to claim 2, in which said non-woven fabric material consists essentially of about 30% viscose and about 70% polyester.

4. The device according to claim 1, in which said non-woven fabric material has a weight of at least about 70 g/m².

5. The device according to claim 1, wherein said non-woven fabric material is bonded to a supporting layer of non-water-absorbent material.

6. The device according to claim 5, wherein said supporting layer is polyester sheet.

7. The device according to claim 1 wherein said detectable reagent is a reagent labelled with a particulate direct label.

8. The device according to claim 7, wherein said particulate direct label is coloured latex.

9. The assay device according to claim 1 wherein said sample receiving member consists essentially of a single layer or sheet of non-woven fabric material bonded to a supporting layer of non-water-absorbent material, said non-woven fabric being a blend of viscose and polyester, and said non-woven fabric having a weight of at least 50 gm/m².

10. The device according to claim 9, wherein said detectable reagent is labelled with a particulate direct label.

11. The device according to claim 10 wherein said particulate direct label is selected from the group consisting of dye sols, metallic sols, non-metallic elemental particles and coloured latex particles.