Stable D-dimer liquid preparation
View Patent ↗The invention is in the field of coagulation diagnosis and relates to a liquid, buffer-based D-dimer composition, which additionally contains fibrinogen and which is suitable as a standard material for control or calibration purposes for D-dimer test procedures.
1. A stable D-dimer composition comprising a mixture comprising a buffer, D-dimer, and fibrinogen, wherein the stable D-dimer composition comprises fibrinogen in a concentration of more than about 0.025 g/l to at most about 2.5 g/l, and wherein the stable D-dimer composition is obtained by incubating said mixture at about 30° C. to about 50° C.
2. The stable D-dimer composition of claim 1 , wherein the fibrinogen is human or animal fibrinogen.
3. The stable D-dimer composition of claim 1 , wherein the fibrinogen concentration is about 0.1 g/l to about 1 g/l.
4. The stable D-dimer composition of claim 1 , wherein the fibrinogen concentration is about 0.2 g/l to about 0.5 g/l.
5. The stable D-dimer composition of claim 1 , wherein the composition is liquid.
6. The stable D-dimer composition of claim 1 , wherein the composition comprises about 0.1 to about 100 mg/l fibrinogen equivalent unit (FEU) D-dimer.
7. The stable D-dimer composition of claim 1 , which additionally comprises an inert protein, and/or a protease inhibitor and/or a detergent and/or an additive having bactericidal and/or fungicidal action.
8. The stable D-dimer composition of claim 7 , wherein the inert protein comprises bovine serum albumin.
9. The stable D-dimer composition of claim 7 , wherein the additive having bactericidal and/or fungicidal action comprises sodium azide.
10. The stable D-dimer composition of claim 1 , wherein the composition comprises about 0 to at most about 10 percent by volume of clot lysis plasma.
11. The stable D-dimer composition of claim 10 , wherein the buffer comprises at most about 5 percent by volume of clot lysis plasma.
12. The stable D-dimer composition of claim 11 , wherein the buffer comprises at most about 1 percent by volume of clot lysis plasma.
13. The stable D-dimer composition of claim 12 , wherein the buffer comprises at most about 0.5 percent by volume of clot lysis plasma.
14. The stable D-dimer composition claim 1 , wherein the mixture is incubated at about 37° C.
15. The stable D-dimer composition claim 1 , wherein the mixture is incubated at about 30° C. to about 50° C. for 4 hours to 7 days.
16. The stable D-dimer composition claim 15 , wherein the mixture is incubated for 12 hours to 3 days.
17. The stable D-dimer composition claim 1 , wherein the stable D-dimer composition is a D-dimer calibrator and/or control composition.