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Process, composition and kit for providing a stable whole blood calibrator/control

  • US 7,390,663 B2
  • Filed: 02/23/2006
  • Issued: 06/24/2008
  • Est. Priority Date: 02/23/2005
  • Status: Expired due to Fees
First Claim
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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:

  • 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 and metabolizing said suspension to a glucose concentration of less than about 20 mg/dL;

    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 non-crosslinking glycolytic inhibitor solution, to form a treated cellular dilution;

    incubating said treated cellular dilution whereby a further reduction in glucose concentration is obtained;

    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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