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US 12,553,907 B2Granted
Whole blood control sample systems and method of preparing and using the same
AssigneePerosphere Technologies Inc.
InventorsXuan Jiang, Lirong Chen, Yongchen Wang, Dardan Osmani, Stefan Zappe, Randy Byrd, Sasha H. Bakhru
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Abstract
The preparation and use of systems to provide surrogate whole blood controls using coagulation modifiers to simulate human whole blood in coagulation assays are disclosed.
Claims23
A whole blood control sample system comprising as separate components:
- a. at least one lyophilizate comprising:
- i. fixed red blood cells sourced from one or more mammalian species;
- ii. plasma sourced from one or more mammalian species;
- and
- iii. an anticoagulant selected from the group consisting of sodium citrate, acid-citrate-dextrose, and EDTA;
- b. at least one diluent;
- and
- c. at least one activation solution comprising a coagulation activator that is calcium chloride,
- wherein at least one of the at least one lyophilizate, the at least one diluent, and the at least one activation solution contains a coagulation modulator,
- wherein the at least one lyophilizate and the at least one diluent are substantially free of the coagulation activator, and
- wherein the coagulation modulator is a serine protease inhibitor and/or rabbit brain cephalin.
8 more elements
A method of preparing a whole blood control sample system comprising steps of:
- providing as separate components:
- a. at least one lyophilizate comprising:
- i. fixed red blood cells sourced from one or more mammalian species;
- ii. plasma sourced from one or more species;
- and
- iii. an anticoagulant selected from the group consisting of sodium citrate, acid-citrate-dextrose, and EDTA;
- b. at least one diluent;
- c. at least one activation solution comprising a coagulation activator that is calcium chloride;
- wherein at least one of the at least one lyophilizate, the at least one diluent, and the at least one activation solution contains a coagulation modulator,
- wherein the at least one lyophilizate and the at least one diluent are substantially free of the coagulation activator, and
- wherein the coagulation modulator is a serine protease inhibitor and/or rabbit brain cephalin;
- adjusting a concentration of the coagulation modulator to provide a whole blood control sample having a defined clotting time;
- and
- mixing an aliquot of the at least one lyophilizate with an aliquot of the at least one diluent to rehydrate the at least one lyophilizate and then adding an aliquot of the at least one activation solution to the rehydrated at least one lyophilizate to provide a whole blood control sample.
11 more elements
Dependencies are inferred from the claim text.