title: The clinical performance of a chemiluminescent immunoassay in detecting anti-cardiolipin and anti-β2 glycoprotein I antibodies. A comparison with a homemade ELISA method.
abstract: BACKGROUND
  Fully automated chemiluminescence immunoassays (CLIAs) are emerging technologies for the detection of anti-cardiolipin (aCL) and anti-β2 glycoprotein I (anti-β2GPI) antibodies for anti-phospholipid syndrome (APS) classification, which is commonly based on an enzyme-linked immunosorbent assay (ELISA) test result. CLIA and a homemade ELISA were used in this study to detect these antibodies, and their performances were compared.
  
  
  METHODS
  Sera were collected from 104 patients with primary APS, 88 seronegative subjects who met the clinical but not the laboratory criteria for APS, and 150 control subjects. IgG/IgM aCL and IgG/IgM anti-β2GPI antibodies were determined in the sera using a CLIA (HemosIL AcuStar®) and a homemade ELISA.
  
  
  RESULTS
  CLIA had a significantly lower comparative sensitivity for IgM aCL and IgG/IgM IgG anti-β2GPI antibodies; its comparative specificity was higher with respect to ELISA for IgM aCL and IgM anti-β2GPI antibodies. The two techniques showed a high, significant agreement (p<0.001) and a significant titer correlation (p<0.001). CLIA also detected IgG/IgM aCL and IgG anti-β2GPI antibodies in the seronegative patients. There was a significantly higher prevalence of IgG aCL and IgG anti-β2GPI antibodies (p<0.001 and p=0.01, respectively) in those patients with respect to that in the control population.
  
  
  CONCLUSIONS
  Despite a lower comparative sensitivity, CLIA showed a higher comparative specificity for some aPL and a good level of agreement and correlation with a homemade ELISA. CLIA also detected some aCL and anti-β2GPI antibodies in the seronegative patients not usually identified by homemade ELISA.
authors.forename: Lauro
authors.initials: L
authors.lastname: Meneghel
authors.forename: Amelia
authors.initials: A
authors.lastname: Ruffatti
authors.forename: Sabrina
authors.initials: S
authors.lastname: Gavasso
authors.forename: Marta
authors.initials: M
authors.lastname: Tonello
authors.forename: Elena
authors.initials: E
authors.lastname: Mattia
authors.forename: Luca
authors.initials: L
authors.lastname: Spiezia
authors.forename: Elena
authors.initials: E
authors.lastname: Campello
authors.forename: Ariela
authors.initials: A
authors.lastname: Hoxha
authors.forename: Marny
authors.initials: M
authors.lastname: Fedrigo
authors.forename: Leonardo
authors.initials: L
authors.lastname: Punzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Simioni
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017153:Antibodies, Anticardiolipin / Q000097:blood*; D016736:Antiphospholipid Syndrome / Q000097:blood; D015331:Cohort Studies; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D053482:beta 2-Glycoprotein I / Q000276:immunology*
chemical_list: D017153:Antibodies, Anticardiolipin; D053482:beta 2-Glycoprotein I