Commutability Assessment of Candidate Reference Materials for Lipoprotein(a) by Comparison of a MS-based Candidate Reference Measurement Procedure with Immunoassays

Background: Elevated concentrations of lipoprotein(a) (Lp(a)) are directly related to an increased risk of cardiovascular diseases, making it a crucial biomarker for clinical risk assessment. However, the lack of global standardization of current Lp(a) measurement procedures (MPs) leads to inconsistent patient care. The IFCC working group on quantitating apolipoproteins by mass spectrometry (MS) has decided to develop a next-generation reference measurement system (RMS) with SI-traceability. This RMS will consist of a MS-based, peptide-calibrated candidate reference measurement procedure (cRMP) and secondary serum-based reference materials (RM) certified for their apolipoprotein(a) content. Methods: A correlation study was performed between the cRMP and immunoassay-based MPs using a panel of 39 clinical samples (CS). In addition, the commutability of 14 different candidate RM was investigated to select a suitable format for the development of future serum-based RM. Results/conclusion: Results of the immunoassay-based MPs (reporting in nmol/L) and the cRMP demonstrated good linear correlations for the CS but significant sample specific differences were also observed. The results of the commutability study show that RM based on unspiked human serum pools are good candidates for a future RM, whereas human pools spiked with recombinant apo(a) show different behavior compared to CS, making them unsuitable as matrix-based RM.

DIKAIOS Ioannis;  ALTHAUS Harald;  ANGLES-CANO Eduardo;  CEGLAREK U.;  COASSIN Stefan;  COBBAERT C.M.;  DELATOUR Vincent;  DIEPLINGER Benjamin;  GRIMMLER Matthias;  HOOFNAGLE A.;  KOSTNER G.M.;  KRONENBERG F.;  KUKLENYIK Z;  LYLE Alicia;  PRINZING U.;  RUHAAK L. R.;  SCHARNAGL Hubert;  VESPER Hubert;  DEPREZ Liesbet; 

2023-03-13

ELSEVIER

JRC128688

0009-8981 (online),   

https://academic.oup.com/clinchem/article/69/3/262/6987870,    https://publications.jrc.ec.europa.eu/repository/handle/JRC128688,   

10.1093/clinchem/hvac203 (online),