Single color reading method for determining fructosamine

• US 5,002,893 A
• Filed: 09/19/1985
• Issued: 03/26/1991
• Est. Priority Date: 09/19/1985
• Status: Expired due to Fees

• Current Assignee: Wallac, Inc.
• Original Assignee: Isolab Inc.
• Inventors: Rosenthal, Murray A.
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US06/937,107
• Time in Patent Office: 2,014 Days
• Field of Search: 436/175, 436/177, 436/34, 436/63, 436/67, 436/87, 436/88, 436/95, 436/111, 436/164, 436/903, 436/904, 436/178, 436/825, 435/25
• US Class Current: 436/87
• 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: Y10S 436/904 Oxidation - reduction indicators
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

A single color determination method of quantization of the amount of fructosamine in a sample such as serum by removing other interfering reducing agents and developing a color with a coloring agent such as tetrazolium salt.

Claims

1. A method of determining the level of fructosamine in a blood sample or a sample derived from blood, said method comprising the steps of eliminating any interfering substances from the sample, controlling the pH of the sample to a value between 10 and 14, adding a coloring agent to the sample and, after a delay, taking a color measurement and determining the fructosamine level in said sample by comparing a single color measurement with that of a single color measurement on a standard solution, wherein the coloring agent and pH conditions are selected such that a change of color in the coloring agent is caused by glucose in the sample that has reacted or associated with an amine group of protein and has undergone a molecular rearrangement to form fructosamine.

2. The method as in claim 1 wherein interfering substances are eliminated by treating the sample with a strong base.

3. The method as in claim 1 wherein the pH of the sample is controlled to a value between 10.5 and 10.8.

4. The method as in claim 1 wherein the pH of the sample is controlled by adding a buffer to the sample, said buffer comprising sodium carbonate and sodium bicarbonate in suitable proportions.

5. The method of claim 1 wherein the coloring agent is tetrazolium salt.

6. The method of claim 1 wherein the salt is 2-(4-iodophenyl)-3-(4-nitrophenyl)-5-phenyl tetrazolium choride.

7. A mehod of determining the fructosamine level in a sample, said method comprising the steps of eliminating any interfering substances from the sample and controlling the pH of the sample to a value between 10 and 14, adding a coloring agent to the sample capable of reacting with fructosamine to develop a color and, after a delay, taking a single color measurement and determining the fructosamine level in said sample by comparing single color measurement with a color developed with said coloring agent and standard fructosamine solution, wherein any reaction between the coloring agent and fructosamine in the sample is stopped by an acid.

8. The method of claim 7 wherein the pH is lowered to below 5.