Enzymatic high range glucose test

• US 4,621,049 A
• Filed: 11/19/1984
• Issued: 11/04/1986
• Est. Priority Date: 11/19/1984
• Status: Expired due to Fees

• Current Assignee: Miles Laboratories, Inc. (Bayer AG)
• Original Assignee: Miles Laboratories, Inc. (Bayer AG)
• Inventors: Wang, Joseph Y.
• Primary Examiner(s): Turk, Arnold
• Application Number:
  US06/673,183
• Time in Patent Office: 715 Days
• Field of Search: 435/14, 435/25, 435/805, 436/95, 422/56, 422/57, 427/2
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

A test composition comprising glucose oxidase, a peroxidatively active component, a chromogenic indicator system capable of providing a detectable response and a borate buffer capable of providing an initial pH above about pH 7 is particularly useful for the semiquantitative determination of high range glucose, (i.e. glucose concentrations of 1,000 mg/dL to 10,000 mg/dL). A preferred indicator system is a water soluble iodide salt and poly(vinylpyrrolidone). The use of a borate buffer capable of providing an initial pH above about pH 7 permits greatly improved resolution for the semiquantitative determination of high range glucose when the test composition is incorported onto a carrier matrix to prepare a solid state unitary test device.

Claims

1. A test composition for the semiquantitative determination of high range glucose in an aqueous test sample, comprising;

glucose oxidase, a peroxidatively active component, a chromogenic indicator system capable of providing a detectable colorimetric response and a borate buffer capable of providing an initial pH above about pH 7.

2. The test composition of claim 1 in which the borate buffer is a boric acid buffer or a phenylboronic acid buffer.

3. The test composition of claim 2 in which the borate buffer is a boric acid buffer and the chromogenic indicator system is a water soluble iodide salt and a poly(vinylpyrrolidone).

4. The test composition of claim 3 in which the boric acid buffer is capable of providing an initial pH between about pH 8.5 and about pH 9.5.

5. A test device for the semiquantitative determination of high range glucose in an aqueous fluid sample comprising:

(a) a carrier matrix, and

(b) a test composition incorporated therewith, the test composition including glucose oxidase, a peroxidatively active component, a chromogenic indicator system capable of providing a detectable response and a borate buffer capable of providing an initial pH above about pH 7.

6. The test device of claim 5 in which the borate buffer is a boric acid buffer or a phenylboronic acid buffer.

7. The test device of claim 6 in which the borate buffer is a boric acid buffer and the chromogenic indicator system is a water soluble iodide salt and poly(vinylpyrrolidone).

8. The test device of claim 7 in which the boric acid buffer is capable of providing an initial pH is between about pH 8.5 and about pH 9.5.

9. A method of preparing the test device for the semiquantitative determination of high range glucose in an aqueous test sample, comprising the steps of:

(a) incorporating with a carrier matrix with a test composition including glucose oxidase, a peroxidatively active component, a chromogenic indicator system capable of providing a detectable response and from about 0.2 M to about 0.8 M borate buffer capable of providing an initial pH above about 7; and

(b) drying.

10. The method of claim 9 in which the borate buffer is a boric acid buffer and the chromogenic indicator system is a water soluble iodide salt and a poly(vinylpyrrolidone).

11. The method of claim 10 in which the boric acid buffer is capable of providing an initial pH between about pH 8.5 and about pH 9.5.

12. The method of claim 9 in which the carrier matrix is paper and the method includes the additional step of pretreating the paper matrix with a borate buffer at an initial pH about 7 prior to incorporating the matrix with the test composition.