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1
University of Washington, Department of Medicine, Northwest Lipid Research Laboratories, Seattle, WA 98103.
2
The University of Chicago, Department of Medicine,
Lipoprotein Study Unit, Chicago, IL 60637.
3
Institute of Medical Genetics, University of Oslo &
Ullevål University Hospital, N-0315 Oslo, Norway.
4
Service de Biochimie, Hospital Armand Trousseau, F-75571
Paris, France.
5
TUV Rheinland Product Safety GmbH, D-51105 Cologne,
Germany.
6
Department of Laboratory Medicine, Children’s Hospital
& Harvard Medical School, Boston, MA 02115.
7
Department of Clinical Laboratory, Omiya Medical Center,
Jichi Medical School, Saitama 3330-0834, Japan.
8
Department of Chemical Pathology, Princess Alexandra
Hospital, Brisbane, Queensland 4102, Australia.
9
St. Nikolaus Stiftshospital Teaching Hospital,
University of Bonn, D-56626 Andernach, Germany.
a Address correspondence to this author at: Northwest Lipid Research Laboratories, 2121 N. 35th Street, Seattle, WA 98103. Fax 206-685-3279; e-mail smm{at}u.washington.edu
Background: As part of the NIH/National Heart, Lung and Blood Institute Contract for the Standardization of Lipoprotein(a) [Lp(a)] Measurements, a study was performed in collaboration with the IFCC Working Group for the Standardization of Lp(a) Assays. The aims of the study, performed with the participation of 16 manufacturers and 6 research laboratories, were to evaluate the IFCC proposed reference material (PRM) for its ability to transfer an accuracy-based value to the immunoassay calibrators and to assess concordance in results among different methods.
Methods: Two different purified Lp(a) preparations with protein mass concentrations determined by amino acid analysis were used to calibrate the reference method. A Lp(a) value of 107 nmol/L was assigned to PRM. After uniformity of calibration was demonstrated in the 22 evaluated systems, Lp(a) was measured on 30 fresh-frozen sera covering a wide range of Lp(a) values and apolipoprotein(a) [apo(a)] sizes.
Results: The among-laboratory CVs for these samples (6–31%) were, in general, higher than those obtained for PRM (2.8%) and the quality-control samples (14%, 12%, and 9%, respectively), reflecting the broad range of apo(a) sizes in the 30 samples and the sensitivity of most methods to apo(a) size heterogeneity. Thus, although all of the assays were uniformly calibrated through the use of PRM, no uniformity in results was achieved for the isoform-sensitive methods.
Conclusions: Linear regression analyses indicated that to various degrees, apo(a) size heterogeneity affects the outcome of the immunochemical methods used to measure Lp(a). We have also shown that the inaccuracy of Lp(a) values determined by methods sensitive to apo(a) size significantly affects the assessment of individual risk status for coronary artery disease.
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