Inter-laboratory variability of anti-beta2-glycoprotein I measurement. A collaborative study in the frame of the European Forum on Antiphospholipid Antibodies Standardization Group

Thromb Haemost. 2002 Jul;88(1):66-73.

Abstract

Inter-laboratory variability of anti-beta2-glycoprotein I antibody measurements (IgG and IgM) was investigated in the frame of the European Forum on Antiphospholipid Antibodies and its Standardization Group. Twenty-eight samples from patients with autoimmune diseases, two samples from blood donors and a set of six calibrators obtained by dilution with normal plasma of a pool of patient samples were sent to 21 European centers. Six of them used commercial kits and the others home-made assays. Marked differences in the steepness of the calibration curves obtained with the calibrator provided were observed. The standard deviations of sample measurement were high. Cut-off of positivity varied from 7 to 90 Forum Units (FU) for IgG and from 10 to 138 FU for IgM, whereas the rate of positivity varied from 50 to 93% for IgG and from 13 to 70% for IgM. No clear relationship between cut-off values and positivity rate could be established for either isotype. Adopting a common cut-off did not markedly improve the overall agreement between centers in positive/negative sample classification. Because of the majority of low positive samples, excellent concordance between centers (as defined by kappa values from 0.8 and 1) occurred only in 13% of cases for IgG and in 6% of cases for IgM, because many selected samples were low-positive. Despite the large variability of anti-beta2-glycoprotein I measurements between centers, the agreement on results with high- and medium-positive samples was good.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Autoantibodies / blood*
  • Autoimmune Diseases / blood
  • Autoimmune Diseases / immunology
  • Calibration
  • Cooperative Behavior
  • Glycoproteins / immunology*
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Observer Variation
  • Reagent Kits, Diagnostic / standards
  • Reference Standards
  • Serologic Tests / methods
  • Serologic Tests / standards
  • beta 2-Glycoprotein I

Substances

  • Autoantibodies
  • Glycoproteins
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic
  • beta 2-Glycoprotein I