Manufacture of test strips

• US 6,130,100 A
• Filed: 09/23/1997
• Issued: 10/10/2000
• Est. Priority Date: 09/27/1996
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Prior, Michael E., Percival, David A., Jobling, Ian
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/935,720
• Time in Patent Office: 1,113 Days
• Field of Search: 422/56, 422/57, 422/58, 435/4, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/805, 435/810, 435/970, 436/169, 436/514, 436/518, 436/530, 436/810
• US Class Current: 436/518
• 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: 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 33/689 related to pregnancy or the gonads
• 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 435/81 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

Abstract

A process of manufacturing test strips of the type comprising a length of porous carrier material capable of acting as a liquid flow path for a sample liquid and having at least zone downstream from a first end of the strip which zone contains an immobilized specific binding agent to act as a capture means during an assay to reveal the presence of an analyte in applied sample liquid, and in which process the specific binding agent is deposited onto a sheet of the porous carrier material which is then blocked and subdivided into a plurality of individual identical test strips, wherein blocking of the porous carrier material is achieved by applying a solution of blocking agent to the sheet upstream from the zone in an amount sufficient to ensure that the solution permeates downstream to beyond the zone. Preferably there is a plurality of zones of immobilized agent arranged in series on the strip, and wherein blocking is achieved by applying a solution of blocking agent to the sheet upstream from the first of the plurality of zones in an amount sufficient to ensure that the solution permeats downstream to beyond the last of the plurality of zones.

Claims

1. In a process of manufacturing test strips of the type comprising a length of porous carrier material capable of acting as a liquid flow path for a sample liquid and having at least one zone downstream from a first end of said strip which zone contains an immobilised specific binding agent to act as a capture means during an assay to reveal the presence of an analyte in applied sample liquid, the improvement wherein the process comprises the steps of depositing said specific binding agent onto a sheet of said porous carrier material followed by blocking and then subdividing the blocked sheet into a plurality of individual identical test strips, the blocking of said porous carrier material being achieved by applying a solution of blocking agent to said sheet upstream from said zone in an amount sufficient to ensure that said solution permeates downstream to beyond said zone to effect said blocking.

2. A process according to claim 1, wherein said porous carrier material is nitrocellulose.

3. A process according to claim 2, wherein said nitrocellulose is backed with plastics sheet material.

4. A process according to claim 3, wherein said plastics sheet material is polyester.

5. A process according to claim 1, wherein said blocking agent solution is applied at or near the edge of the sheet which constitutes the first ends of said strips after subdivision.

6. A process according to claim 1, wherein said specific binding agent is deposited as a line of reagent across the width of said sheet.

7. A process according to claim 1, wherein said blocking agent is a non-specific protein.

8. A process according to claim 7, wherein said non-specific protein is an albumin.

9. A process according to claim 8, wherein said albumin is bovine serum albumin.

10. A process according to claim 1, where in said blocking agent is polyvinyl alcohol.

11. A process according to claim 1, wherein there is a plurality of zone of immobilised agent arranged in series on said strip, and wherein blocking is achieved by applying a solution of blocking agent to said sheet upstream from the first of said plurality of zones in an amount sufficient to ensure that said solution permeates downstream to beyond the last of said plurality of zones.

12. A process according to claim 11, wherein said zones include at least one test zone to reveal the presence of said analyte, and a control zone downstream from said test zone which control zone contains an immobilised specific binding agent to act as a capture means during the generation of a control signal during said assay, and said specific binding agent in said control zone does not bind said specific binding agent in said test zone.

13. A process according to claim 12, wherein said specific binding agent immobilised in said test zone is an antibody raised in a first species and said specific binding reagent immobilised in said control zone is an antibody raised against an antibody from a species different from said first species.