NDLI: Technical aspects in laboratory testing for antiphospholipid antibodies: is standardization an impossible dream?

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Technical aspects in laboratory testing for antiphospholipid antibodies: is standardization an impossible dream?

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Reber, Guido Boehlen, Françoise de Moerloose, Philippe
Description	Country affiliation: Switzerland Author Affiliation: Reber G ( Haemostasis Unit, Division of Angiology and Haemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland. guido.reber@hcuge.ch)
Abstract	Anticardiolipin (aCL) and anti-beta2 glycoprotein I (anti-beta2GPI) assays are widely performed because they are part of the laboratory criteria for the antiphospholipid syndrome (APS). Despite several standardization workshops and the availability of a worldwide accepted calibrator material for aCL, a high variability in numerical assay results and in sample classification is still observed in comparative studies and external quality control surveys. For anti-beta2GPI assays, comparison of numerical values is impeded by the absence of a common calibrator material, and external quality surveys similarly show a large overlap in sample classification. Numerous variables impact assay results, among them the source and integrity of beta2GPI, the secondary calibration process, and the assessment and derivation of cutoff values. For both assays, the vast majority of laboratories use commercial kits whose number has risen considerably in the past years. However, many problems persist, and there is a need to improve the comparability in assay results. The use of monoclonal antibodies as reference calibrators has to be especially considered, with their suitability evaluated by future collaborative studies and external quality controls surveys. Manufacturers should provide more precise information on results obtained when testing control groups for establishing reference ranges and cutoff values. From the customers' perspective, it is important that each laboratory, even if using commercial kits, assesses its local cutoff value whenever possible. In the field of autoimmunity, assay standardization is a difficult but nevertheless important task. Much more effort is needed to reduce the high interlaboratory variability in assay results even if absolute standardization cannot be feasibly achieved.
File Format	HTM / HTML
ISSN	00946176
Issue Number	4
Volume Number	34
e-ISSN	10989064
Journal	Seminars in Thrombosis and Hemostasis
Language	English
Publisher	Thieme
Publisher Date	2008-06-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Vascular Diseases Discipline Hematology Antibodies, Anticardiolipin Blood Antiphospholipid Syndrome Diagnosis Hematologic Tests Standards Reagent Kits, Diagnostic Beta 2-glycoprotein I Immunology Antibodies, Monoclonal Chemistry Calibration Methods Humans Quality Control Reference Standards Reproducibility Of Results Genetics Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Hematology Cardiology and Cardiovascular Medicine

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