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Last Updated: March 28, 2024

Claims for Patent: 6,610,291


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Summary for Patent: 6,610,291
Title: Ready-to-use ristocetin cofactor test reagent possessing long-term stability
Abstract:The present invention relates to a ready-to-use ristocetin cofactor test reagent possessing long-term stability for use in coagulation tests.
Inventor(s): Patzke; Jurgen (Marburg, DE), Braun; Konrad (Ebsdorfergrund, DE)
Assignee: Dade Behring Marburg GmbH (Marburg, DE)
Application Number:09/739,649
Patent Claims:1. A liquid preparation comprising a suspension of fixed platelets, wherein the liquid preparation is not lyophilized prior to use and is capable of remaining stable for at least 10 months after storage in the liquid state, and wherein, during the process of making the liquid preparation, the platelets are treated with a serine protease inhibitor, fixed, and suspended in an aqueous solution which contains at least one neutral protein and does not contain any ristocetin or snake venom.

2. The preparation as claimed in claim 1 which exhibits a reactivity of at least 80% of the starting value as measured in a ristocetin cofactor test after storage in the liquid state for at least 12 months.

3. The preparation as claimed in claim 1 for measuring and quantifying von Willebrand factor.

4. The preparation as claimed in claim 1 in the form of a ready-to-use (approximately 50,000-2,000,000 platelets/.mu.l) preparation.

5. The preparation as claimed in claim 4 containing 200,000-1,000,000 platelets/.mu.l.

6. A test kit for a ristocetin cofactor test, which kit contains the preparation as claimed in any one of claims 1 to 4.

7. A test kit for a ristocetin cofactor test, which kit contains the preparation as claimed in claim 5.

8. A ristocetin cofactor test comprising the preparation as claimed in any one of claims 1 to 4 in which the concentration of ristocetin in the test mixture is from 1 to 2.4 mg/ml.

9. The ristocetin cofactor test according to claim 8 in which the concentration of ristocetin in the test mixture is from 1.25 to 2 mg/ml.

10. A ristocetin cofactor test comprising the preparation as claimed in claim 5 in which the concentration of ristocetin in the test mixture is from 1 to 2.4 mg/ml.

11. The ristocetin cofactor test according to claim 10 in which the concentration of ristocetin in the test mixture is from 1.25 to 2 mg/ml.

12. The preparation as claimed in claim 1, wherein the aqueous solution buffered.

13. The preparation as claimed in claim 1, wherein the liquid preparation of fixed platelets is capable of remaining stable for at least 12 months after storage in the liquid state.

14. The preparation as claimed in claim 5, containing approximately 600,000 platelets/.mu.l.

15. The preparation as claimed in claim 1 wherein said at least one neutral protein comprises an albumin.

16. The preparation as claimed in claim 15 wherein the albumin is bovine serum albumin.

17. The preparation as claimed in claim 15 wherein the albumin is human albumin.

18. The preparation as claimed in claim 1, wherein the preparation is suitable for commercial use.

Details for Patent 6,610,291

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2019-12-29
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2019-12-29
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2019-12-29
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2019-12-29
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 02/17/1995 ⤷  Try a Trial 2019-12-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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