Anticardiolipin Antibody Assay: a Methodological Analysis for a better Consensus in Routine Determinations

Angela Tincani; Flavio Allegri; Marielle Sanmarco; Massimo Cinquini; Marco Taglietti; Genesio Balestrieri; Takao Koike; Kenji Ichikawa; Pierluigi Meroni; Marie Claire Boffa

doi:10.1055/s-0037-1616089

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2001; 86(02): 575-583
DOI: 10.1055/s-0037-1616089

Review Article

Schattauer GmbH

Anticardiolipin Antibody Assay: a Methodological Analysis for a better Consensus in Routine Determinations

A Cooperative Project of the European Antiphospholipid Forum

Angela Tincani

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Flavio Allegri

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Marielle Sanmarco

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Massimo Cinquini

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Marco Taglietti

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Genesio Balestrieri

¹Clinical Immunology Unit, Brescia Hospital, Italy, Laboratoire d’Immunologie, Hopital de la Conception, Marseille, France

,

Takao Koike

²Department of Medicine II, Hokkaido University School of Medicine, Sapporo, Japan

,

Kenji Ichikawa

²Department of Medicine II, Hokkaido University School of Medicine, Sapporo, Japan

,

Pierluigi Meroni

³IRCCS Istituto Auxologico Italiano, University of Milan, Italy

,

Marie Claire Boffa

⁴Department of Internal Medicine JC, Piette, Hôpital de la Pitié, Paris, France

› Author Affiliations

Abstract

Summary

Despite the widely recognized practical importance of anticardiolipin (aCL) ELISA, the reliability of this test has been recently discussed. In order to investigate this area on European scale, we sent to 30 experienced centers a questionnaire focusing on the diagnostic procedures applied to patients with antiphospholipid syndrome (APS) and on the detailed protocols used to perform aCL. Anticardiolipin ELISA was found to be the most frequently performed test in patients with suspected APS, but significant difference was shown among the various protocols. The cross-laboratory multiple examination of ten serum samples evaluated independently by the 24 centers pointed out the difficulty in getting comparable results. Therefore a “consensus” protocol was derived from the aCL methods giving the best performance. The materials and reagents necessary to perform the “consensus” method, including, as putative standards, one IgG and one IgM monoclonal antibody (HCAL and EY2C9) were distributed to 19 Centers. The results of one IgG and one IgM aCL high positive sera measured in serial dilutions were compared. A progressive decrease in the variability of the values obtained for a given sample appeared evident when all the laboratories used the same standard, in their own in-house ELISA and even more in the “consensus” ELISA.

Our data show that aCL ELISA standardization is necessary in order to obtain comparable results in different laboratories.

Keywords

Antiphospholipid syndrome - anticardiolipin antibodies - standardization

Full Text

References

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