WHOLE BLOOD CONTROL SAMPLE SYSTEMS AND METHOD OF PREPARING AND USING THE SAME

1 . A whole blood control sample system comprising as separate components:

a. at least one lyophilizate comprising:

i. fixed red blood cells sourced from one or more mammalian species;

ii. plasma sourced from one or more mammalian species; and

iii. an anticoagulant selected from the group consisting of sodium citrate, acid-citrate-dextrose, and EDTA;

b. at least one diluent; and

c. at least one activation solution comprising a coagulation activator that is calcium chloride,

wherein the at least one activation solution contains a coagulation modulator that is a serine protease inhibitor,

wherein the at least one lyophilizate includes an effective amount of rabbit brain cephalin to further modulate clotting time of the whole blood control sample, and

wherein the at least one diluent and the at least one lyophilizate are substantially free of the coagulation activator.

2 . The whole blood control system of claim 1 , wherein the serine protease inhibitor is benzamidine.

3 . The whole blood control system of claim 2 , wherein the benzamidine is present in a range of about 0.11 mM to about 11 mM.

4 . The whole blood control system of claim 3 , wherein the rabbit brain cephalin is present in a range of about 0.048 mg/mL to about 0.96 mg/mL.

5 . The whole blood control system of claim 4 , wherein the system comprises two or more activation solutions, with each activation solution having a different concentration of benzamidine, a single lyophilizate, and a single diluent.

6 . The whole blood control system of claim 4 , wherein the system is provided as a kit having two or more aliquots of activation solution, with each activation solution having a different concentration of benzamidine, two or more aliquots of identical lyophilizate, and two or more aliquots of identical diluent.