Glucose measurement control reagent and method of making the same

• US 5,028,542 A
• Filed: 02/07/1990
• Issued: 07/02/1991
• Est. Priority Date: 02/07/1990
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation
• Inventors: Usmani, Arthur, Storhoff, Diane, Bontrager, Roger, Tabb, David, Kennamer, Jim
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US07/476,085
• Time in Patent Office: 510 Days
• Field of Search: 436/8-18, 436/95, 252/408.1, 435/14
• US Class Current: 436/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2496/25 containing added polymers to stabilise biological material against degradation or mantain viscosity or density, e.g. gelatin, polyacrylamides, polyvinyl alcohol casein G01N2333/4731, albumins G01N2333/76, polysaccharides G01N2400/10
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The invention relates to a non-serum based control reagent for glucose determination. Rather than using modified serum, the control reagent contains water, glucose, and the viscosity agent polystyrene sulphonate. The control reagent may also contain a buffer, preservatives, surfactants or surface active agents. A method of making the control reagent is also disclosed.

Claims

1. Serum-free control reagent for glucose determination comprising a mixture of:

(i) a predetermined amount of glucose,

(ii) water, and

(iii) polystyrene sulphonate or a salt thereof.

2. Serum-free control reagent of claim 1, wherein said polystyrene sulphonate is present in an amount ranging from about 0.5 to about 60 weight percent of said control reagent.

3. Serum-free control reagent of claim 2, wherein said polystyrene sulphonate is present in an amount ranging from about 20 to about 30 weight percent of said control reagent.

4. Serum-free control reagent of claim 1, wherein said polystyrene sulphonate is present in an amount ranging from about 0.5 to about 40 weight percent of said control reagent.

5. Serum-free control reagent of claim 1, wherein said polystyrene sulphonate has an atomic weight of from about 5000 to about 6,000,000.

6. Serum-free control reagent of claim 5, wherein said polystyrene sulphonate has an atomic weight of from about 35,000 to about 750,000.

7. Serum-free control reagent of claim 6, wherein said polystyrene sulphonate has an atomic weight of from about 70,000 to about 500,000.

8. Serum-free control reagent of claim 1, further comprising a buffer.

9. Serum-free control reagent of claim 8, wherein said buffer is selected from the group consisting of 4-(2-hydroxy ethyl-1-piperazene-ethane sulphonic acid),

2-(N-cyclohexylamino)ethane sulphonic acid,

3-(N-morpholino)propane sulphonic acid,

2-(N-morpholino)ethane sulphonic acid, and

3-(cyclohexylamino)-1-1-propane-sulphonic acid.

10. Serum-free control reagent of claim 1, further comprising at least one preservative.

11. Serum-free control reagent of claim 10 wherein said preservative is imidazolidinyl urea, methylparaben, methanol(((2-(dihydro-5-methyl-3(2H)-oxazolyl)-1-methylethyloxy)methoxy) methoxy), phenoxyethanol, or gentamyacin sulphate.

12. Serum-free control reagent of claim 1, further comprising a surfactant.

13. Serum-free control reagent of claim 1, further comprising an ionic salt.

14. Serum-free control reagent of claim 1, further comprising a colored or color forming compound.

15. Serum-free control reagent for glucose determination consisting essentially of a mixture of:

(i) glucose,

(ii) water,

(iii) polystyrene sulphonate or a salt thereof,

(iv) a preservative, and

(v) a surfactant or surface active agent.

16. Lyophilized, serum-free control reagent comprising a mixture of a predetermined amount of glucose, and a polystyrene sulphonate or salt thereof.

17. Process for making a serum free glucose control reagent comprising mixing a predetermined amount of glucose with a polystyrene sulphonate or salt thereof.

18. Process of claim 17, further comprising mixing water with said glucose and polystyrene sulphonate.

19. Process of claim 17, further comprising mixing at least one material selected from the group consisting of a buffer, a preservative, a surfactant, an inorganic salt and a colored or color forming compound to said predetermined amount of glucose and polystyrene sulphonate or salt thereof.