Recommendations for the selection and use of protocols for assignment of values to reference materials.

It is essential that testing of patient samples give values that are traceable to those in a recognized, authorizative reference material. In addition, samples used for laboratory proficiency testing must have values assigned from such a reference material if results are to be comparable among materials and laboratories. As a result, the assignment of values to secondary and tertiary reference materials, calibrants, controls, and proficiency samples should be performed as precisely as possible, within reasonable limits. The intent of this document is to give guidelines for assignment of values at three levels of transfer. 1) from primary to secondary reference, materials, such as international or national references; 2) from secondary to tertiary reference materials, such as manufacturers' in-house calibrants and controls; and 3) from tertiary reference materials, such as manufacturers' in-house calibrants and controls; and 3) from tertiary reference materials to working calibrants and controls. It is hoped that these guidelines will facilitate the selection and utilization of an appropriate value transfer protocol for each level of value assignment. Because of the wide variety and nature of analytes, however, the guidelines are intentionally broad and may require revision for specific analytes.