Process for preparing a biological composition for use as a reference control in diagnostic analysis

Abstract

A process for making a biological composition for use as a blood serum reference composition in diagnostic analysis. The process comprises: (a) adding calcium to citrated plasma and mixing well to form decitrated plasma; (b) adding thrombin to the decitrated plasma and mixing well to form a clot of fibrin; (c) performing at least one freeze-thaw routine on the clot to cause the fibrin to contract; (d) removing the fibrin to thereby obtain serum; (e) molecular washing and ultrafiltering the serum and thereby obtaining concentrated serum; and (f) adding to the concentrated serum at least one alkylene polyol having from 2-5 carbon atoms in an amount such that said composition's non-biological component comprises from about 40 to about 85 weight percent water and from about 15 to about 60 weight percent of said alkylene polyol.

Dependencies are inferred from the claim text.