Glucose reference control for glucose test strips

• US 4,729,959 A
• Filed: 02/24/1986
• Issued: 03/08/1988
• Est. Priority Date: 02/24/1986
• Status: Expired due to Term

• Current Assignee: Streck Laboratories Inc.
• Original Assignee: Streck Laboratories Inc.
• Inventors: Ryan, Wayne L.
• Primary Examiner(s): Kyle, Deborah L.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/832,068
• Time in Patent Office: 743 Days
• Field of Search: 436/11-18, 435/14
• US Class Current: 436/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

A stable glucose reference control has been found in which the true value and the measured value of glucose in blood, colorimetrically obtained with glucose test strips, is approximately the same. The glucose reference control comprises an aqueous suspension of:

(i) 40 to 500 mg/dL of glucose, and

(ii) about 0.1 to 0.3×10¹² /dL red blood cells fixed with a fixing agent to render the red blood cells incapable of metabolizing glucose.

Claims

1. A glucose reference control for glucose test strips consisting essentially of an aqueous suspension of:

(i) about 40 to 500 mg/dL of glucose, and

(ii) about 0.1 to 0.3×

10¹² /dL red blood cells fixed with a fixing agent to render said red blood cells incapable of metabolizing glucose, the number of said fixed red blood cells being sufficient to provide a glucose reference control for glucose test strips in which the true value of glucose and the measured value is approximately the same.

2. A glucose reference control according to claim 1 wherein the fixing agent is an aldehyde.

3. glucose reference control according to claim 2 wherein the aldehyde is glutaraldehyde.

4. A glucose reference control according to claim 1 wherein the fixing agent is an imidinating agent.

5. A glucose reference control according to claim 4 wherein the imidinating agent is dimethylsuberimidate.

6. A glucose reference control according to claim 1 including a phosphate buffer.

7. A glucose reference control according to claim 6 wherein the phosphate buffer is sodium phosphate.

8. A glucose reference control according to claim 1 wherein the fixed human red blood cell concentration is about 0.2 to 0.3×

10¹² /dL.

9. A glucose reference control according to claim 1 wherein the fixed red blood cell concentration is 0.3×

0.10¹² /dL.

10. A glucose reference control according to claim 1 wherein the glucose content is about 60 mg to 250 mg/dl.

11. A glucose reference control according to claim 1 wherein the red blood cells are human red blood cells.

12. A glucose reference control according to claim 1 wherein the red blood cells are bovine red blood cells.