Hemostasis measurement device quality control formulations

A method of preparing a formulation for testing an efficacy of at least one viscoelastic analysis reagent, the formulation having a target bovine citrated plasma concentration, a target human tissue factor concentration, and a target heparin concentration, the method comprising:

• a) determining the target concentration of bovine citrated plasma for the formulation by:
• i) preparing a series of bovine citrated plasma dilutions, the series of bovine citrated plasma dilutions having at least two members,
• ii) measuring a first viscoelastic characteristic for each member of the series of bovine citrated plasma dilutions to obtain a first value for each member of the series of bovine citrated plasma dilutions, said first viscoelastic characteristic having a target value,
• iii) calculating a first linear regression from the first value for each member of the series of bovine citrated plasma dilutions, and
• iv) extrapolating a predicted bovine citrated plasma concentration corresponding to the first viscoelastic characteristic target value from the first linear regression, the predicted bovine citrated plasma concentration being the target bovine citrated plasma concentration;
• b) determining the target concentration of human tissue factor for the formulation by:
• i) preparing a series of human tissue factor dilutions, the series of human tissue factor dilutions having at least two members,
• ii) measuring a second viscoelastic characteristic for each member of the series of human tissue factor dilutions to obtain a second value for each member of the series of human tissue factor dilutions, said second viscoelastic characteristic having a target value,
• iii) calculating a second linear regression from the second value for each member of the series of human tissue factor dilutions, and
• iv) extrapolating a predicted human tissue factor concentration corresponding to the second viscoelastic characteristic target value from the second linear regression, the predicted human tissue factor concentration being the target human tissue factor concentration;
• c) determining the target concentration of heparin for the formulation by:
• i) preparing a series of heparin dilutions, the series of heparin dilutions having at least two members,
• ii) measuring a third viscoelastic characteristic for each member of the series of heparin dilutions to obtain a third value for each member of the series of heparin dilutions, said third viscoelastic characteristic having a target value,
• iii) calculating a third linear regression from the third value for each member of the series of heparin dilutions, and
• iv) extrapolating a predicted heparin concentration corresponding to the third viscoelastic characteristic target value from the third linear regression, the predicted heparin concentration being the target heparin concentration;
• and
• d) preparing the formulation by combining the bovine citrated plasma, human tissue factor, and heparin together such that the formulation comprises the bovine citrated plasma at the target bovine citrated plasma concentration, the human tissue factor at the target human tissue factor concentration, and the heparin at the target heparin concentration.