International Technidyne Corporation

Ted C K Lee

Frank M LaDuca

Amanda B McBride

Anne Jessica Gorman

Paul Michael D'Agostino

A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is &#x3b3;-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37&#xb0; C.

Assay for low molecular weight heparin

A prothrombin time reagent for determination of low molecular weight heparin in frsh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is &#x3b3;-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37&#xb0; C.

A reagent for determining prothrombin time (PT) including a recombinant protein tissue factor, a mixture of synthetic phospholipids, and a beta, gamma, or delta amino acid stabilizing compound is described for monitoring extrinsic blood coagulation activities. The source for the recombinant protein tissue factor is rabbit brain, and the phospholipids employed are palmitoyloleoylphosphatidylcholine (POPC) and palmitoyloleoylphosphatidylserine (POPS). The particular formulation buffer used to dilute the lipidated tissue factor provides a reagent that is optionally dried without lyophilization and remains stable for at least about 2 weeks at 37 C as either a liquid or a dried powder. A method for preparing the improved PT reagent and a method of using the reagent to analyze blood PT is also provided.

Preparation of stable liquid and dried synthetic prothrombin time reagents

A method for preparation of an air-dried prothrombin time (PT) reagent which uses a recombinant protein and synthetic phospholipids is described. The source for the recombinant protein is rabbit brain, and the phospholipids employed are palmitoyloleoylphosphatidylcholine (POPC) and palmitoyloleoylphosphatidylserine (POPS). The particular formulation buffer used to dilute the lipidated tissue factor provides a reagent that is dried without lyophilization and remains stable for at least 2 weeks at 37 C. A method for preparing the improved PT reagent and a method of using the reagent to analyze blood PT is also provided.

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Matawan, NJ, United States of America

Ted C K Lee