title: The importance of commutability of reference materials used as calibrators: the example of ceruloplasmin.
abstract: BACKGROUND
  Different methods for ceruloplasmin tend to give different results in external quality assessment schemes. During the production of the certified reference material ERM-DA470k/IFCC discrepant measurement results were also found for ceruloplasmin measured with different methods, and consequently the protein could not be certified in the material.
  
  
  METHODS
  We performed a commutability study with 30 serum samples and the reference materials ERM-DA470, ERM-DA470k/IFCC, and ERM-DA472/IFCC, using 6 different methods. Data were analyzed according to the CLSI Guideline C53-A to assess whether the reference materials had the same behavior as the serum samples with respect to measurement results obtained with combinations of the methods used.
  
  
  RESULTS
  Measurement results from different methods showed a good linear correlation for the serum samples. ERM-DA470 showed marked noncommutability for certain combinations of methods. ERM-DA470k/IFCC and ERM-DA472/IFCC were commutable for more combinations of methods. The lack of commutability of ERM-DA470 for certain combinations of methods correlates with results from the UK National External Quality Assessment Service showing discrepancies between results from these methods. For serum stored in the presence of sodium azide the results from different methods are essentially equivalent.
  
  
  CONCLUSIONS
  Ceruloplasmin in ERM-DA470 is a fully documented example of a situation in which, due to lack of commutability, the use of a common material for calibration did not lead to harmonization .
authors: Institute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, Belgium. ingrid.zegers@ec.europa.eu
authors: Ingrid
authors: I
authors: Zegers
authors: Robert
authors: R
authors: Beetham
authors: Thomas
authors: T
authors: Keller
authors: Joanna
authors: J
authors: Sheldon
authors: David
authors: D
authors: Bullock
authors: Finlay
authors: F
authors: MacKenzie
authors: Stefanie
authors: S
authors: Trapmann
authors: Hendrik
authors: H
authors: Emons
authors: Heinz
authors: H
authors: Schimmel
mesh_terms: D002138:Calibration; D002570:Ceruloplasmin / Q000032:analysis*; D057075:Enzyme Assays / Q000592:standards*; D006801:Humans; D012015:Reference Standards; D044967:Serum / Q000201:enzymology*
chemical_list: D002570:Ceruloplasmin