Commutability of Serum Protein Values: Persisting Bias among Manufacturers Using Values Assigned from the Certified Reference Material 470 (CRM 470) in the United States

Significant among-manufacturer differences in values for serum proteins persist 7 years after the introduction of the international reference material (Certified Reference Material 470; Reference Preparation for Proteins in Human Serum). In some cases, such as transthyretin and C4, the biases actually continue to increase. Further efforts at standardization are needed in order to improve commutability of results among laboratories and are essential if universal reference intervals are to be developed.