Hemostasis measurement device quality control formulations
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Publication Number
US-11906532-B2
Publication Date
2024-02-20
Expiration Date
Abstract
Quality control formulations that do not require human donor-derived blood components for use in testing the efficacy of viscoelastic analysis reagents, and methods for preparing these formulations, are described.
Core Innovation
A donor-free quality control formulation is provided for viscoelastic analysis reagent efficacy testing. The formulation includes bovine citrated plasma, recombinant human tissue factor, and heparin, with target concentrations for the components and use on viscoelastic analysis cartridges.
The target concentrations are determined by preparing series dilutions of each component, measuring viscoelastic characteristics for each dilution member, and fitting linear regression to relate viscoelastic characteristic values to component concentration. Predicted component concentrations corresponding to target viscoelastic characteristic target values are extrapolated from the linear regression, including clot initiation time-related characteristics and amplitude-related characteristics.
The disclosure includes rationale connecting increased CK/CKH R times to degradation of CaCl2 or heparinase cartridge components and provides example QC formulations that detect simulated degradation on TEG Global Hemostasis cartridges. The formulation and preparation approach is integrated with viscoelastic testing such as using a TEG 6s Hemostasis Analyzer system and microfluidic cartridge testing workflow.
Claims Coverage
The independent claims cover three inventive features for preparing a donor-free QC formulation for viscoelastic analysis reagent efficacy testing: determining target concentrations of bovine citrated plasma, human tissue factor, and heparin using viscoelastic measurements with linear regression and extrapolation; a streamlined variant based on predicted concentrations from measured viscoelastic characteristics; and a formulation composition range. The claims center on matching target viscoelastic characteristics and combining the components at target concentrations.
Target bovine citrated plasma concentration determination via regression and extrapolation
Preparing a series of bovine citrated plasma dilutions having at least two members; measuring a first viscoelastic characteristic for each member of the series to obtain a first value for each member; calculating a first linear regression; and extrapolating a predicted bovine citrated plasma concentration corresponding to the first viscoelastic characteristic target value.
Target human tissue factor concentration determination via regression and extrapolation
Preparing a series of human tissue factor dilutions having at least two members; measuring a second viscoelastic characteristic for each member of the series to obtain a second value for each member; calculating a second linear regression; and extrapolating a predicted human tissue factor concentration corresponding to the second viscoelastic characteristic target value.
Target heparin concentration determination via regression and extrapolation
Preparing a series of heparin dilutions having at least two members; measuring a third viscoelastic characteristic for each member of the series to obtain a third value for each member; calculating a third linear regression; and extrapolating a predicted heparin concentration corresponding to the third viscoelastic characteristic target value.
Combining components at target concentrations
Preparing the formulation by combining the bovine citrated plasma, human tissue factor, and heparin together such that the formulation comprises each component at its target concentration.
Formulation composition ranges for donor-free efficacy testing
A formulation for testing an efficacy of at least one viscoelastic analysis reagent comprising 60-90% bovine citrated plasma, 0.05-0.20% human tissue factor, and 0.05-0.30 U/ml heparin.
The independent claims are directed to determining target concentrations of bovine citrated plasma, human tissue factor, and heparin from viscoelastic measurements and linear regression or predicted concentrations, then combining the components at those target concentrations; a composition range for the donor-free efficacy testing formulation is also claimed.
Stated Advantages
Not explicitly described in patent.
Documented Applications
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