Hematology control product with increased closed vial stability

• US 6,569,682 B2
• Filed: 07/27/2001
• Issued: 05/27/2003
• Est. Priority Date: 07/27/2001
• Status: Expired due to Term

• Current Assignee: Coulter International Corp. (Danaher Corporation)
• Original Assignee: Coulter International Corp. (Danaher Corporation)
• Inventors: Elliott, Michael, Gerula, Theodore J., Ortiz, Nery, Jacobs, Dana B., Goldson, Wayne, Whitley, Penny
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/917,452
• Publication Number:
  US 20030044988A1
• Time in Patent Office: 669 Days
• Field of Search: 436/8, 436/10, 436/16, 436/18, 436/63, 252/408.1, 435/2, 435/4, 435/29
• US Class Current: 436/10
• 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 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

An improved blood suspension media for hematological compositions, having particular utility with a red blood cell component for devices using electronic and optical means for blood determinations, and processes for using the suspension media. The suspension media finds particular utility in providing the hematology control product with a stable and consistent MCV and RDW for an extended product shelf life.

Claims

1. A hematology control product comprising a closed vial of a lyseable red blood cell component and a xanthine compound in an isotonic suspension medium, wherein said xanthine compound is in an amount sufficient to provide a shelf life of greater than 60 days of the hematology control product and wherein said lyseable red blood cell component is present in an amount sufficient to be measurable with an automated hematology instrument and wherein said hematology control product has an reported mean cell volume which corresponds substantially with the mean cell volume of human whole blood.

2. The hematology control product of claim 1, wherein the hematology control product has an osmolality from about 200 to 400 milliosmoles.

3. The hematology control product of claim 2, which further comprises compatible preservative compositions in an amount sufficient to provide fungicidal and bactericidal activity.

4. The hematology control product of claim 3, which contains potassium, sodium chloride, phosphate and sulfate ions each in the amount from approximately 0.001 to 0.1 moles.

5. The hematology control product of claim 2, where the xanthine compound is from about 0.1 to 1.0% by weight/volume.

6. The hematology control product of claim 2, where the xanthine compound is present in an amount of from about 0.2 to 0.7% by weight/volume.

7. The hematology control product of claim 1, which further comprises a white blood cell component.

8. The hematology control product of claim 7, wherein the white blood cell component simulates at least three subpopulations of white blood cells.

9. The hematology control product of claim 8, wherein the white blood cell component simulates five subpopulations of white blood cells.

10. A hematology control product comprising a closed vial of a lyseable red blood cell component and caffeine in an isotonic suspension medium, wherein said caffeine is in an amount sufficient to provide a shelf life of greater than 60 days of the hematology control product and wherein said lyseable red blood cell component is present in an amount sufficient to be measurable with an automated hematology instrument and wherein said hematology control product has an reported mean cell volume which corresponds substantially with the mean cell volume of human whole blood.

11. The hematology control product of claim 10, which further comprises one or more pH adjusting agents to provide a pH in the range from approximately 5.8 to 6.8.

12. A method of using a hematology control product to determine the accuracy and reproducibility of the operation of a hematology instrument comprising the steps of:

a) providing the hematology control product comprising a lyseable red blood cell component and a xanthine compound in an isotonic suspension medium, wherein said xanthine compound is in an amount sufficient to provide a shelf life of greater than 60 days of the hematology control product and wherein said lyseable red blood cell component is present in an amount sufficient to be measurable with an automated hematology instrument and wherein said hematology control product has an reported mean cell volume which corresponds substantially with the mean cell volume of human whole blood, and wherein said hematology control product has a known reference value for each component type present in the product;

b) determining the reference value for each component type in the hematology control product with an automated hematology instrument; and

c) comparing the reference value for each component type obtained from step b) above with the known reference value for each component type from step a) above.

13. The method of claim 12, wherein the reference value comprises a mean cell volume value.

14. The method of claim 13, wherein the reference value further comprises a red blood cell distribution width value.

15. The method of claim 12, wherein the hematology control product has an osmolality from about 200 to 400 milliosmoles.

16. The method of claim 12, wherein the xanthine compound is from about 0.1 to 1.0% by weight/volume.

17. The method of claim 16, wherein the hematology control product further comprises a white blood cell component.

18. The method of claim 17, wherein the white blood cell component simulates at least three subpopulations of white blood cells.

19. The method of claim 17, wherein the white blood cell component simulates five subpopulations of white blood cells.

20. The method of claim 12, wherein the xanthine compound is present in an amount of from about 0.2 to 0.7% by weight/volume.

21. A method of using a hematology control product to determine the accuracy and reproducibility of the operation of a hematology instrument comprising the steps of:

a) providing said hematology control product comprising a lyseable red blood cell component and caffeine in an isotonic suspension medium, wherein said caffeine is in an amount sufficient to provide a shelf life of greater than 60 days of said hematology control product and wherein said lyseable red blood cell component is present in an amount sufficient to be measurable with an automated hematology instrument and wherein said hematology control product has an reported mean cell volume which corresponds substantially with the mean cell volume of human whole blood, and wherein said hematology control product has a known reference value for each component type present in the product;

b) determining the reference value for each component type in the hematology control product with an automated hematology instrument; and

c) comparing the reference value for each component type obtained from step b) above with the known reference value for each component type from step a) above.

22. The method of claim 21, wherein the hematology control product further comprises one or more pH adjusting agents to provide a pH in the range from approximately 5.8 to 6.8.