Kit for fructosamine determination

• US 5,866,352 A
• Filed: 07/02/1997
• Issued: 02/02/1999
• Est. Priority Date: 07/27/1993
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Original Assignee: Roche Diagnostic Systems Incorporated (Roche Holding AG)
• Inventors: Vorberg, Ewald
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US08/886,799
• Time in Patent Office: 580 Days
• Field of Search: 435/4, 435/14, 435/25, 436/87, 436/175, 436/176, 436/825, 436/903
• US Class Current: 435/25
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

A kit of two liquid reagent components for determining the fructosamine content of a blood sample measured by color change, and methods of determining fructosamine content of a blood sample using these two liquid reagents are disclosed.

Claims

1. A kit of separate liquid reagent components for determining the fructosamine content in a blood sample comprising a first liquid reagent component which is at a substantially neutral pH and contains a neutral buffering agent, a tetrazolium salt at a concentration of 0.5 to 1.5 mmol/L, an enzyme with oxidizing activity which prevents non-specific reduction of the tetrazolium salt, and a detergent which removes turbidity;

and a second liquid reagent component which is at a basic pH and contains a basic buffering agent.

2. A kit of claim 1 wherein the tetrazolium salt is nitro-blue tetrazolium.

3. A kit of claim 1 wherein the pH of the second liquid reagent component is from about 9 to about 12.5.

4. A kit of claim 1 wherein the pH of the second liquid reagent component is from about 10 to about 11 and the basic buffering agent is a carbonate buffer.

5. A kit of claim 1 wherein the pH of the first liquid reagent component is from about 7 to about 8.

6. A kit of claim 1 wherein the enzyme is uricase.

7. A kit of claim 1 wherein the detergent which removes turbidity is selected from an ionic or non-ionic detergent or a combination of an ionic detergent and a non-ionic detergent.

8. A kit of claim 7 wherein the ionic detergent is sodium cholate.

9. A kit of claim 7 wherein the non-ionic detergent is isotridecylpoly(ethylene-glycolether)n, where n is 8 to 12.

10. A kit of claim 7 wherein the detergent which removes turbidity additionally comprises a salt of a strong acid.