title: Automated, semi-automated, and manual analyses of anti-cardiolipin and anti-β2-glycoprotein I antibodies in women with a history of miscarriage.
abstract: BACKGROUND
  Anti-cardiolipin and β2-glycoprotein I antibodies represent important diagnostic parameters in routine hematology. In this study, five different automated, semi-automated, and manual immunoassays detecting IgG/IgM anti-cardiolipin and anti-β2 -glycoprotein I antibodies were tested.
  
  
  METHODS
  A total of 162 samples from women with a history of miscarriage were recruited from 110 different G&O outpatient centers in Germany.
  
  
  RESULTS
  For both anti-cardiolipin and anti-β2 -glycoprotein I antibodies, considerable differences in the percentage of positive results were seen between all five methods, and itemization of all positive test results revealed a poor accordance. These findings were confirmed by Cohen's kappa coefficients.
  
  
  CONCLUSIONS
  Our study revealed a moderate to poor accordance between five different test systems for anti-cardiolipin and anti-β2 -glycoprotein I antibodies. Such deviations may result in clinical misinterpretation of data and may lead to wrong therapeutic consequences. Therefore, further standardization of all tests for anti-phospholipid antibodies should be achieved.
authors.affiliation: Institute for Transfusion Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany. email@kai-gutensohn.de
authors.forename: K
authors.initials: K
authors.lastname: Gutensohn
authors.forename: D
authors.initials: D
authors.lastname: Vossen
authors.forename: A
authors.initials: A
authors.lastname: Strate
authors.forename: J F
authors.initials: JF
authors.lastname: Kersten
authors.forename: M
authors.initials: M
authors.lastname: Hofbauer
authors.forename: T
authors.initials: T
authors.lastname: Krieger
mesh_terms: D000022:Abortion, Spontaneous / Q000276:immunology*; D000328:Adult; D017152:Antibodies, Antiphospholipid / Q000032:analysis* / Q000276:immunology; D001331:Automation; D019963:Clinical Chemistry Tests / Q000379:methods* / Q000592:standards; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006801:Humans; D011247:Pregnancy; D053482:beta 2-Glycoprotein I / Q000276:immunology*
chemical_list: D017152:Antibodies, Antiphospholipid; D053482:beta 2-Glycoprotein I