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