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 ERMDA470, 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. ERMDA470k/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
Authors: 
MACKENZIE Finlay, BEETHAM Robert, BULLOCK David, ZEGERS Ingrid, KELLER Thomas, SHELDON Joanna, SCHIMMEL Heinz, EMONS Hendrik, TRAPMANN Stefanie
Publication Year
Publication Year: 
2013
Type

Type:

Appears in Collections
Appears in Collections: 
Institute for Reference Materials and Measurements
Science Areas
JRC Institutes
Publisher
Publisher: 
AMER ASSOC CLINICAL CHEMISTRY
ISSN
ISSN: 
0009-9147
Citation
Citation: 
CLINICAL CHEMISTRY p. 1322-1329 no. 9 vol. 59