Reagent test strip for analyte determination having a hemolyzing agent

• US 6,998,248 B2
• Filed: 11/30/2004
• Issued: 02/14/2006
• Est. Priority Date: 02/02/2000
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Yani, Adva, Huang, Paing C.
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US11/001,490
• Publication Number:
  US 20050095659A1
• Time in Patent Office: 441 Days
• Field of Search: 435/14, 435/975, 422/56
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/975 Kit

Abstract

Reagent test strips and methods for their use in the determination of the concentration of an analyte, e.g. glucose, in a physiological sample, are provided. The subject reagent test strips include one or more members of an analyte oxidation signal producing system and at least one hemolyzing agent. The subject reagent test strips and methods are particularly suited for use in the detection of blood glucose concentrations. Also provided are kits that include the subject test strips for use in practicing the subject methods.

Claims

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

(a) a reagent test strip comprising;

(i) a porous matrix;

(ii) at least one member of an analyte oxidation signal producing system; and

(iii) at least one hemolyzing agent in an amount sufficient to produce 5–

20% by volume hemolysate in the sample; and

(b) at least one of;

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

(ii) an analyte standard.

2. The kit according to claim 1, wherein said analyte is glucose.

3. The kit according to claim 1, wherein said physiological sample is blood.

4. The kit according to claim 1, wherein said means for obtaining said physiological sample is a lance.

5. The kit according to claim 1, wherein said kit further comprises an automated instrument for detecting a signal produced by said signal producing system and relating said detected signal to the concentration of analyte in the sample.

6. The kit according to claim 1, wherein said at least one member of an analyte oxidation signal producing system comprises an enzyme that oxidizes an analyte to produce hydrogen peroxide.

7. The kit according to claim 6, wherein said signal producing system further comprises an enzyme that converts at least one substrate into a chromogenic product in the presence of hydrogen peroxide.

8. The kit according to claim 1, wherein said hemolyzing agent is present in an amount sufficient to produce hemolysis which is equivalent to hemolysate concentration in a physiological sample applied to said porous matrix in an amount ranging from about 10 to 20% by volume.