Process, composition and kit for providing a stable whole blood calibrator/control
First Claim
1. 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.
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Accused Products
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 which 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.
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Citations
37 Claims
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1. A process for preparing a whole blood calibrator/control for calibrating glucose measuring systems over an extended period of time comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 32, 33)
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19. The process of claim 19 wherein said incubation period provides incubation of said treated cellular dilution for from about 2 to about 120 hours.
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21. A glucose control product for determining accuracy and reproducibility of operation of a glucose measuring instrument comprising:
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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. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 34, 35)
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31. 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. - View Dependent Claims (36, 37)
Specification