Protein standardization V: value transfer. A practical protocol for the assignment of serum protein values from a Reference Material to a Target Material.

Abstract We present a practical protocol for the assignment of values to serum proteins in a Target Material using a Reference Material. This protocol is based on the model of Direct Value Transfer between serum matrices and is intended to improve the value assignment of commercial calibrators using the Reference Material CRM 470 (now labeled ERM-DA 470) or similar reference materials. The procedure describes the general as well as the practical principles involved in the value assignment (with examples). The practical transfer protocol is based on multiple assays of 6 dilutions of the Reference Material and 6 dilutions of the Target Material. The transfer protocol requires several measurements a day repeated on several days, an important prerequisite being that all reconstitutions and dilutions are controlled by weighing thus reducing uncertainty in the transfer. In open systems that allow the use of the Reference Material as calibrator and the Target Material as samples, the proportionality of the two materials (the presence or absence of matrix effects) can now be directly assessed by evaluating a single regression plot. If no matrix effects are found, the regression line will pass through zero with a slope equal to the ratio of the concentrations of the two materials. In closed systems, the dedicated commercial calibrator has to be used as such; the Reference Material and the Target Material are now assayed as samples against this calibrator. Two regression plots are therefore obtained; if no matrix effects are present among the two materials and the calibrator, both the Reference and Target Materials will show zero intercepts, and the ratio of the two slopes will equal the ratio of the concentrations. Clin Chem Lab Med 2008;46