Table 1.

Information to be included in the documentation of an RM that is commutable for a stated number of MPs.

  • Selection criteria for individuals from whom CSs were obtained for the commutability assessment

  • Number of CSs used in the commutability assessment and their collection, processing, storage, and distribution conditions

  • Description of the experimental design used to assess commutability; state the reference MP if included in the experimental design

  • Criteria used to conclude that an RM was commutable with clinical samples

  • Summary of the results of the commutability assessment in sufficient detail that the conclusions can be verified; complete experimental results and data analysis must be available to a user on request

  • MPs for which commutability was demonstrated, including the specific models of instruments and the part numbers and lot numbers of reagents, calibrators, and calibration confirmation materials