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Clinical Chemistry 44: 1629-1640, 1998;
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(Clinical Chemistry. 1998;44:1629-1640.)
© 1998 American Association for Clinical Chemistry, Inc.

Lipids and Lipoproteins

International Federation of Clinical Chemistry standardization project for the measurement of lipoprotein(a). Phase I. Evaluation of the analytical performance of lipoprotein(a) assay systems and commercial calibrators

Jillian R. Tate1,a, Nader Rifai2, Kåre Berg3, Rémy Couderc4, Francesco Dati5, Gert M. Kostner6, Ikunosuke Sakurabayashi7, and Armin Steinmetz8

1 Department of Chemical Pathology, Princess Alexandra Hospital, Ipswich Rd., Woolloongabba, Queensland 4102, Australia.

2 Department of Laboratory Medicine, Children's Hospital and Harvard Medical School, Boston, MA 02115.

3 Institute of Medical Genetics, University of Oslo and Ullevål University Hospital, N-0315 Oslo, Norway.

4 Service de Biochimie, Tenon Hospital, F-75970 Paris, France.

5 Scientific Affairs Chemistry, Dade Behring, Inc., D-35001 Marburg, Germany.

6 Institute for Medical Biochemistry, University of Graz, A-8010 Graz, Austria.

7 Department of Clinical Laboratory, Omiya Medical Center, Jichi Medical School, Saitama 330-0834, Japan.

8 Center for Internal Medicine, University of Marburg, D-35001 Marburg, Germany.
a Author for correspondence. Fax 61-7-3240-7070; e-mail tatej{at}health.qld.gov.au.

A secondary reference material for lipoprotein(a) is required to standardize the measurement of lipoprotein(a) in clinical laboratories worldwide. Towards this aim, the International Federation of Clinical Chemistry Working Group for the Standardization of Lipoprotein(a) Assays has initiated a standardization project involving a total of 33 diagnostic company and clinical chemistry laboratories from 12 countries. In Phase 1, the analytical performance of 40 lipoprotein(a) assay systems was evaluated by testing sera and manufactured lipoprotein(a) calibrator materials for precision, linearity, and parallelism. Twenty test systems were nonoptimized according to the results for a pooled serum, which tested nonlinear in 16 systems and imprecise in 4. Acceptable analytical properties and harmonization of lipoprotein(a) values were shown by some commercial calibrators, suggesting their possible use as reference materials. This study highlights the problems that currently occur for lipoprotein(a) measurement in existing assay systems.




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