Method for manufacturing a tissue factor-based prothrombin time reagent
AssigneeLifeScan, Inc.
InventorsRichard Jenny, Paul E. Haley, Brian Earp
Life of this patent
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Abstract
A method for manufacturing a tissue factor-based prothrombin-time reagent includes combining predetermined quantities of tissue factor (TF), phospholipid and detergent-containing buffer to create a TF/phospholipid mixture. In this combining step, the quantity of TF is predetermined based upon its measured TF activity. Next, the detergent is removed from the TF/phospholipid mixture to produce an essentially detergent-free TF/phospholipid mixture that is useful as a tissue factor-based PT reagent. The method can include the use of hydrophobic resin that has been prescreened based on phospholipid recovery to accomplish the removal of the detergent.
Claims11
A method for manufacturing a tissue factor-based prothrombin time (PT) reagent, the method comprising:
- combining predetermined quantities of tissue factor (TF), phospholipids and detergent-containing buffer to create a TF/phospholipids mixture, wherein the predetermined quantity of TF is based on a measured activity of TF to function as a cofactor for factor VIIa;
- and
- removing the detergent from the TF/phospholipids mixture to create an essentially detergent-free TF/phospholipids vesicle mixture, thereby creating a tissue factor-based PT reagent.
Dependencies are inferred from the claim text.