| 摘要 |
<p>This invention relates generally to the preparation of coagulation control compositions suitable for measuring human coagulation characteristics. The coagulation controls provided herein include novel combinations of reagents and novel processing which provide superior performance characteristics including long term stability as a liquid formulation at 4 °C after freeze thaw or lyophilization and reconstitution. The control is based on mammalian plasma, of which the majority is primate plasma and a minority is non-primate plasma as well as a variety of other stabilizing materials such as a buffer, a fibrinolysis inhibitor, a coagulation factor stabilizer, a carbohydrate for stabilizing proteins upon freeze-thaw and a preservative to maintain sterility. The invention also includes a new method to prepare coagulation controls with abnormal clotting times by adding coagulation control inhibitors to the plasma.</p> |
