Control solution for a blood glucose monitor

• US 5,605,837 A
• Filed: 02/14/1996
• Issued: 02/25/1997
• Est. Priority Date: 02/14/1996
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: McGarraugh, Geoffrey, Karimi, Saker A., Yu, Yeung S.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US08/601,386
• Time in Patent Office: 377 Days
• Field of Search: 436/8, 436/14, 436/16, 436/18, 422/56, 422/61, 435/14, 252/408.1, 423/449.1
• US Class Current: 436/14
• 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 436/106664 Blood serum or blood plasma standard or control

Abstract

A control solution for use with a photometric blood glucose strip contains glucose in an aqueous suspension of carbon black. The control solution mimics blood when applied to a whole blood glucose test strip, which is then inserted into a meter. A meter reading within a predetermined range indicates that meter and strip are operating satisfactorily. Preferably the control solution is buffered to a neutral pH and includes chloride ion to provide a stable end point for the glucose reaction. Depending on the glucose concentration, the solution checks meter and strip operation at high, low, and normal blood glucose levels.

Claims

1. The control solution that mimics whole blood for use with a photometric blood glucose strip, which comprises a suspension of opaque iron oxide or carbon water, a dispersant to keep the particles in suspension, and a predetermined concentration of glucose.

2. The control solution of claim 1 in which the opaque particles comprise carbon particles.

3. The control solution of claim 2 in which the concentration of particles is at least about 0.015% w/v.

4. The control solution of claim 2 in which the particles are substantially spherical, with a diameter of about 40 nm.

5. The control solution of claim 1 further comprising an end point stablizer, which stablizes absorbance of 660 nm radiation by the control solution a predetermined time after contact with a photometric blood glucose strip.

6. The control solution of claim 5 in which the end point stabilizer is chloride ion.

7. The control solution of claim 6 in which the chloride ion concentration is in a range from about 0.1% to about 0.25% w/v.

8. The control solution of claim 7 in which the chloride ion concentration is about 0.20% w/v.

9. The control solution of claim 1 further comprising a buffer.

10. The control solution of claim 9 in which the buffer comprises EDTA.

11. The control solution of claim 9 in which the buffer maintains the solution at a pH in a range from about 6.5 to about 7.5.

12. The control solution of claim 1 further comprising an antifreeze.

13. The control solution of claim 12 in which the antifreeze comprises glycerol.

14. The control solution of claim 1 further comprising a preservative.

15. The control solution of claim 14 in which the preservative is imidazolidinyl urea.

16. The control solution of claim 15 in which the imidazolidinyl urea concentration is at least about 0.07% w/v.