	US 7,390,663 B2
	Process, composition and kit for providing a stable whole blood calibrator/control
Wayne L. Ryan, Omaha, Nebr. (US); and Bradford A. Hunsley, LaVista, Nebr. (US)
Assigned to Streck, Inc., LaVista, Nebr. (US)
Filed on Feb. 23, 2006, as Appl. No. 11/362,362.
Claims priority of provisional application 60/656154, filed on Feb. 23, 2005.
Prior Publication US 2006/0211072 A1, Sep. 21, 2006
Int. Cl. G01N 31/00 (2006.01); G01N 33/48 (2006.01)

U.S. Cl. 436—14 [436/8; 436/16; 436/18; 436/63; 436/95; 436/174; 436/176; 435/2; 435/14]

32 Claims

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.