Methods of manufacturing reagent test strips

• US 6,800,488 B2
• Filed: 12/13/2000
• Issued: 10/05/2004
• Est. Priority Date: 12/13/2000
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Khan, Tahir Sadik, Rice, Edward G., Yu, Yeung Siu
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/737,179
• Publication Number:
  US 20020072124A1
• Time in Patent Office: 1,392 Days
• Field of Search: 422/56, 422/58, 422/61, 436/164, 436/169, 436/170, 436/95, 436/166
• US Class Current: 436/166
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Methods for making reagent test strips are provided. In the subject methods, a test strip precursor made up of an elongated support material having a planar surface and a narrow stripe of reagent material positioned along its central axis is cut according to an inter-digitating pattern to produce the plurality of reagent test strips. The initial precursor material may be a tape or in the form of a card. Also provided are the reagent test strips produced by the subject methods and kits that include the same. The subject reagent test strips and kits find use in analyte detection and/or concentration determination assays.

Claims

1. A method of manufacturing a plurality of reagent test strips, said method comprising:

(a) providing a test strip precursor comprising an elongated support material having a planar surface and a stripe of reagent material positioned along a central axis thereof; and

(b) cutting said test strip precursor into a plurality of reagent test strips according to an inter-digitating pattern comprising a series inter-laced, oppositely oriented projections positioned on said test strip precursor, wherein each of said strips produced includes a sample region and a handling region, where said reagent material is located in said sample region.

2. The method according to claim 1, wherein said test strip precursor is a continuous tape.

3. The method according to claim 1, wherein said test strip precursor is a card, wherein said card has a generally rectangular shape.

4. The method according to claim 1, wherein said method further comprises producing said test strip precursor.

5. The method according to claim 1, wherein said sample region includes a hole in said support material which is covered by said reagent material.

6. The method according to claim 1, wherein said sample region of said strip has an aspect ratio of about 0.5 relative to the handling region.

7. The method according to claim 1, wherein said test strips produced by said method can be used in a hand-held optical meter.

8. The reagent test strip according to claim 1, wherein said reagent test strip can be read by a hand held optical meter.

9. The method according to claim 1, wherein said reagent material comprises a signal producing system.

10. The method according to claim 9, wherein said signal producing system produces a color that can be related to the concentration of an analyte in a sample contacted with said reagent material.

11. The method according to claim 9, wherein said signal producing system produces an electrical current that can be related to the concentration of an analyte in a sample contacted with said reagent material.

12. A reagent test strip produced according to the method of claim 1, wherein said reagent test strip has a sample region and a handling region, wherein said reagent material is located in said sample region.

13. The reagent test strip according to claim 12, wherein said sample reagent of said test strip has an aspect ratio of that is about 0.5 relative to the handling region.

14. A method for determining the concentration of an analyte in a sample, said method comprising:

(a) applying a fluid sample to a reagent test strip of claim 12;

(b) detecting a signal from said reagent test strip; and

(c) relating said detected signal to the concentration of analyte in said sample to determine the concentration of said analyte in said fluid sample.

15. The method according to claim 14, wherein said fluid sample is a biological sample.

16. The method according to claim 14, wherein said analyte is glucose.

17. The method according to claim 14, wherein said detecting and relating steps are performed by a hand held optical meter.

18. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) a reagent test strip according to claim 12; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

(ii) an analyte standard.

19. The kit according to claim 18, wherein said means for obtaining said physiological sample is a lance.

20. The kit according to claim 18, wherein said analyte standard comprises a standardized concentration of a known reagent.

21. The kit according to claim 18, wherein said kit comprises said means for obtaining said physiological sample and said analyte standard.

22. The kit according to claim 18, wherein said kit further comprises a hand held optical meter.

23. A method of manufacturing a plurality of reagent test strips, said method comprising;

(a) providing a test strip precursor comprising an elongated support material having a planar surface and a stripe of reagent material positioned along a central axis thereof; and

(b) cutting said test strip precursor into a plurality of reagent test strips according to an inter-digitating pattern comprising a series of inter-laced projections positioned on said test strip precursor representing test strips, each test strip comprising a sample region and a handling region and wherein said handling regions of adjacent test strips are positioned on opposite sides of said test strip precursor,

wherein each of said strips produced includes a sample region and a handling region, where said reagent material is located in said sample region.