Process, composition and kit for providing a stable whole blood calibrator/control
OwnerWayne Ryan, Bradford Hunsleyinventors
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Abstract
The present invention is directed toward a stable calibrator and/or control, kit and process for using in a glucose monitoring instrumentation. Principally, the instant invention teaches a glycolyzed red blood cell component, which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound. The glycolyzed red blood cell component may be added to fresh plasma along with an amount of glucose to form a simulated whole blood glucose control product, effective for maintaining a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.
Claims31
A process for preparing a whole blood calibrator/control for calibrating glucose measuring systems over an extended period of time comprising:
- supplying a whole blood sample including a cellular component and a plasma component;
- forming a whole blood suspension by addition of an anticoagulant to said whole blood sample;
- treating said suspension to separate said plasma from said cellular component to form a concentrated cellular component;
- combining said concentrated cellular component with a predetermined amount of a glycolytic inhibitor solution, to form a treated cellular dilution;
- washing said treated cellular dilution with at least one buffer solution effective to substantially remove said glycolytic inhibitor solution;
- preparing a stable whole blood suspension by intermixing said treated and washed cellular dilution and plasma in amounts effective to form a stable reconstituted whole blood sample;
- and
- formulating said stable reconstituted whole blood sample to contain a particular final glucose concentration;
- whereby said particular final glucose concentration remains substantially constant over time, thereby providing a stable glucose control/calibrator for use in glucose measuring systems.
The process of claim 19 wherein said incubation period provides incubation of said treated cellular dilution for from about 2 to about 120 hours.
A glucose control product for determining accuracy and reproducibility of operation of a glucose measuring instrument comprising:
- a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound;
- said red blood cell component present in an amount sufficient to provide a red blood cell count, when resuspended in fresh plasma, in a range of about 0.05×0×106/mm3 to about 10.0×106/mm3;
- and
- fresh plasma in an amount effective for resuspending said red blood cell component to a desired concentration, thereby forming a simulated whole blood glucose control product;
- whereby said simulated whole blood glucose control product is effective to maintain a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.
A composition suitable for producing a simulated whole blood glucose control product effective to maintain a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument comprising:
- a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound.
Dependencies are inferred from the claim text.