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Thromb Haemost. 2019 Mar 1. doi: 10.1055/s-0039-1679901. [Epub ahead of print]

Detection of Anti-Cardiolipin and Anti-β2glycoprotein I Antibodies Differs between Platforms without Influence on Association with Clinical Symptoms.

Author information

1
Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht University, Maastricht, The Netherlands.
2
Synapse Research Institute, Maastricht, The Netherlands.
3
Department of Haemostasis and Thrombosis, Viapath Analytics, Guy's & St. Thomas' Hospitals, London, United Kingdom.
4
Centre Hospitalier Universitaire de Nîmes et Université de Montpellier, Montpellier, France.
5
Ivan Sechenov First Moscow State Medical University, Moscow, Russia.
6
2nd Department of Internal Medicine, Jagiellonian University Medical College, Jagiellonian University, Krakow, Poland.
7
Vascular Medicine Division and Regional Competence Center for Rare Vascular and Systemic Autoimmune Diseases, Centre Hospitalier Regional Universitaire de Nancy, Université de Lorraine, Inserm, DCAC, Nancy, France.
8
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.
9
Division of Angiology and Haemostasis, University Hospital Geneva, University of Geneva, Geneva, Switzerland.
10
Department of Clinical Chemistry and Hematology, Gelre Hospitals, Apeldoorn, The Netherlands.
11
Department of Clinical Chemistry and Haematology, Center for Circulatory Health, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
12
Coagulation Laboratory, Department of Diagnostic Sciences, Ghent University Hospital, Ghent University, Ghent, Belgium.

Abstract

BACKGROUND:

 The anti-phospholipid syndrome (APS) is characterized by thrombosis and/or pregnancy morbidity with persistent presence of anti-phospholipid antibodies (aPL). Laboratory criteria include aPL detection by coagulation tests for lupus anticoagulant (LAC) or solid phase assays measuring anti-β2 glycoprotein I (aβ2GPI) or anti-cardiolipin (aCL) immunoglobulin (Ig) G/IgM antibodies. External quality control programs illustrate that commercially available aPL assays produce variable results.

OBJECTIVE:

 We aimed to investigate the agreement and diagnostic accuracy of solid phase assays.

MATERIALS AND METHODS:

 In this multi-centre study, 1,168 patient samples were tested on one site for aCL and aβ2GPI IgG/IgM antibodies by four solid phase test systems. Samples included APS patients, controls and monoclonal antibodies (MoAB) against different epitopes of β2GPI. LAC was determined by the local centre.

RESULTS:

 aCL IgM assays resulted in the most discrepancies (60%), while aCL IgG and aβ2GPI IgM assays resulted in lower discrepancies (36%), suggesting better agreement. Discrepant samples displayed lower median aPL titers. Dependent on the solid phase test system, odds ratios (ORs) for thrombosis and pregnancy morbidity ranged from 1.98 to 2.56 and 3.42 to 4.78, respectively. Three platforms showed lower sensitivity for MoAB directed against the glycine (Gly) 40-arginine (Arg) 43 epitope of domain I of β2GPI.

CONCLUSION:

 Poor agreement was observed between different commercially available aCL and aβ2GPI IgG/IgM assays, hampering uniformity in the identification of aPL-positive patients. Clinical association was globally concordant between solid phase test systems considering results of the four aPL together. An assay sensitive in detecting the MoAB against Gly40-Arg43 of domain I of β2GPI reached the highest OR for thrombosis.

PMID:
30822809
DOI:
10.1055/s-0039-1679901

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