Control compositions and methods of use for coagulation tests

• US 6,746,872 B2
• Filed: 01/16/2002
• Issued: 06/08/2004
• Est. Priority Date: 01/16/2002
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hartmann, Christa, Earp, Brian, Zheng, Xiang Yang, Chow, Herbert
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US10/055,788
• Publication Number:
  US 20030153084A1
• Time in Patent Office: 874 Days
• Field of Search: 436/8, 436/16, 436/63, 436/69, 436/79, 436/164, 436/165, 422/61, 422/73, 422/99, 422/102, 422/939, 435/2, 435/13, 600/368, 600/369, 73/644.1
• US Class Current: 436/16
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• 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 436/106664 Blood serum or blood plasma standard or control

Abstract

Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions include particles capable of aggregating in plasma and calcium ions which, when mixed with plasma, simulate the behavior of whole blood in a coagulation test. The methods include providing calcium ions and particles capable of aggregating in plasma, combining the particles and calcium ions with plasma to form a control composition, and applying the control composition to a coagulation test. The devices include a container having at least two compartments, with one compartment including particles that promote or induce aggregation of a protein or proteins in plasma, and the other compartment includes a solution of calcium ions. The kits include a control composition including a container of calcium ions, a container of particles capable of inducing aggregation of proteins in plasma, and one or more coagulation test devices.

Claims

1. A control composition for a coagulation test, comprising:

(a) plasma aggregatable particles; and

(b calcium ions and;

(c) hemoglobin.

2. The control composition of claim 1, further comprising at least one optical contrast enhancer.

3. The control composition of claim 1, wherein said particles comprise polymeric beads having charged functional groups on surfaces thereof.

4. The control composition of claim 1, wherein said calcium ions comprise a calcium halide.

5. The control composition of claim 1, further comprising plasma.

6. A control composition for a coagulation test, comprising:

(a) plasma aggregatable particles;

(b) a solution of calcium ions;

(c) plasma; and

(d) hemoglobin.

7. The control composition of claim 6, wherein said solution of calcium ions further comprises an optical contrast enhancer.

8. The control composition of claim 6, wherein said solution of calcium ions further comprises a dissolved dye.

9. The control composition of claim 6, wherein said particles are suspended in a solution comprising an antifreeze.

10. The control composition of claim 6, wherein said particles comprise polymeric beads having charged functional groups on surfaces thereof.

11. The control composition of claim 10, wherein said polymeric beads comprise polystyrene, and said charged functional groups comprise carboxylate groups.

12. The control composition of claim 10, wherein said polymeric beads contain a dye.

13. A control composition for a coagulation test, comprising:

(a) a suspension of polymeric beads having charged functional groups on surfaces of said beads;

(b) a solution of calcium ions;

(c) citrated plasma; and

(d) hemoglobin.

14. The control composition of claim 13, wherein said solution of calcium ions includes an optical contrast enhancer.

15. The control composition of claim 13, wherein said solution of calcium ions comprises a calcium halide solution.

16. The control composition of claim 13, wherein said polymeric beads comprise polystyrene.

17. The control composition of claim 13, wherein said charged functional groups comprise carboxylato groups.

18. The control composition of claim 13, wherein said polymeric beads contain a dye.

19. The control composition of claim 13, wherein said suspension of polymeric beads further comprises an antifreeze.

20. The control composition of claim 13, wherein said solution of calcium ion further comprises a dissolved dye.

21. A method for evaluating a coagulation test, comprising:

(a) providing a composition including calcium ions hemoglobin and plasma aggregatable particles;

(b) combining said calcium ions hemoglobin and said particles with plasma to form a control composition; and

(c) introducing said control composition and to said coagulation test.

27. The method of claim 21, wherein said coagulation test comprises a prothrombin time test.

28. The method of claim 21, wherein said providing said composition comprises:

(a) providing a suspension of said particles;

(b) providing a solution of said calcium ions; and

(c) providing a hemoglobin solution and

(d) combining said suspension of said particles, said hemoglobin solution and said solution of calcium ions.

29. The method of claim 28, wherein said particles comprise polymeric beads having charged functional groups on surfaces thereof.

30. The method of claim 21, wherein providing said composition comprises including at least one optical contrast enhancer in said composition.

22. The method of 21, further comprising monitoring coagulation of said control composition.

23. The method of claim 22, further comprising determining a coagulation time for said control composition.

24. The method of claim 23, further comprising determining a relationship between said coagulation time of said control composition and a coagulation time of whole blood associated with said plasma in said control composition.

25. The method of claim 24, further comprising determining a relationship between said coagulation time for said control composition, and a coagulation time using a reference test.

26. The method of claim 25, further comprising determining a calibration curve for said coagulation test.

31. A method for evaluating a coagulation test, comprising:

(a) providing plasma aggregatable particles;

(b) providing a solution of calcium ions and a solution containing hemoglobin;

(c) combining said particles with said solution of said calcium ions and said solution containing hemoglobin;

(d) adding citrated plasma to said combined said particles and said solutions of said calcium ions and hemoglobin to form a control composition; and

(e) introducing said control composition to a coagulation test.

32. The method of claim 31, further comprising monitoring coagulation of said control composition.

33. The method of claim 32, further comprising determining a coagulation time for said control composition.

34. The method of claim 33, further comprising determining a relationship between said coagulation time of said control composition, and a coagulation time of whole blood associated with said plasma in said control composition.

35. The method of claim 34, further comprising determining a relationship between said coagulation time for said control composition and a coagulation time using a reference test.

36. The method of claim 35, further comprising determining a calibration curve for said coagulation test.

37. The method of claim 31, wherein said solution of said calcium ions comprises an aggregation enhancer.

38. The method of claim 37, wherein said aggregation enhancer comprises hemoglobin.

39. The method of claim 31, wherein said particles comprise polymeric beads with charged functional groups on surfaces thereof.

40. The method of claim 31, wherein said solution of said calcium ions comprises a calcium halide solution.

41. The method of claim 31, wherein said providing said particles comprises suspending said particles in an antifreeze.

42. The method of claim 31, wherein said coagulation test comprises a prothrombin time test.