CardioMet
Published January 16, 2023 | Version v1
Journal article Open

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

Creators

  • 1. European Commission, Joint Research Centre (JRC)
  • 2. Siemens Healthcare Diagnostics Products GmbH
  • 3. French Institute of Health and Medical Research (INSERM) Université Paris Cité
  • 4. Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig
  • 5. Institute of Genetic Epidemiology, Medical University of Innsbruck
  • 6. Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center
  • 7. Laboratoire National de Métrologie et d'Essais
  • 8. Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern
  • 9. DiaSys Diagnostic Systems GmbH
  • 10. Department of Laboratory Medicine and Pathology, University of Washington
  • 11. Division of Molecular Biology and Biochemistry, Medical University of Graz,
  • 12. Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC)
  • 13. Roche Diagnostics GmbH
  • 14. Division of Molecular Biology and Biochemistry, Medical University of Graz
  • 15. Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC

Description

Elevated concentrations of lipoprotein(
a) [Lp(a)] are directly related to an increased risk of
cardiovascular diseases, making it a relevant biomarker
for clinical risk assessment. However, the lack of global
standardization of current Lp(a) measurement procedures
(MPs) leads to inconsistent patient care. The
International Federation for Clinical Chemistry and
Laboratory Medicine working group on quantitating
apolipoproteins by mass spectrometry (MS) aims to develop
a next-generation SI (International system of
units)-traceable reference measurement system consisting
of a MS-based, peptide-calibrated reference measurement
procedure (RMP) and secondary serum-based
reference materials (RMs) certified for their apolipoprotein(
a) [apo(a)] content. To reach measurement standardization
through this new measurement system, 2
essential requirements need to be fulfilled: a sufficient
correlation among the MPs and appropriate commutability
of future serum-based RMs.
METHODS: The correlation among the candidate RMP
(cRMP) and immunoassay-based MPs was assessed
by measuring a panel of 39 clinical samples (CS).
In addition, the commutability of 14 different candidate
RMs was investigated.
RESULTS: Results of the immunoassay-based MPs and
the cRMPs demonstrated good linear correlations for
the CS but some significant sample-specific differences
were also observed. The results of the commutability
study show that RMs based on unspiked human serum
pools can be commutable with CS, whereas human
pools spiked with recombinant apo(a) show different
behavior compared to CS.
CONCLUSIONS: The results of this study show that unspiked
human serum pools are the preferred candidate
secondary RMs in the future SI-traceable Lp(a)
Reference Measurement System.

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