title: Clinical significance of a single test for anti-cardiolipin antibodies in patients with systemic lupus erythematosus.
abstract: OBJECTIVE
  Clinicians have difficulty interpreting results of tests for anti-cardiolipin antibodies (aCL) because of conflicting reports of the clinical associations of these antibodies in patients with systemic lupus erythematosus (SLE). We therefore decided to evaluate the clinical associations of aCL in an effort to facilitate interpretation of single reports of either positive or negative test results. We also assessed the role of estrogen on the development of aCL.
  
  
  METHODS
  The study population consisted of 85 consecutive outpatients with SLE and 40 control subjects. Serum samples and clinical and laboratory data were obtained from each patient and control. Testing for aCL was performed using a standardized enzyme-linked immunoabsorbent assay developed at an international workshop.
  
  
  RESULTS
  The presence of aCL was documented in 42.4 percent of patients with SLE and 7.5 percent of control subjects. In patients with SLE, these antibodies were significantly associated with thrombosis, fetal loss, and thrombocytopenia, but not with other manifestations. Measurement of all isotypes optimized clinical correlations. Titers did not add clinical utility. Fluctuations of levels of aCL occurred, making it difficult to interpret a single negative result. Among control subjects, the presence of aCL was not significantly more common in women who used oral contraceptives.
  
  
  CONCLUSIONS
  Our findings suggest that positive results of testing for aCL correlate with a predisposition for thrombosis, fetal loss, and thrombocytopenia in patients with SLE; however, the test is not predictive for other clinical manifestations of SLE, including activity and severity of disease. We believe that measurement of all isotypes of aCL should be performed in patients with SLE considering pregnancy, to identify those with a high risk of fetal loss, and in SLE patients with a thrombotic episode.
authors.affiliation: Department of Medicine, UCLA School of Medicine 90024.
authors.forename: K C
authors.initials: KC
authors.lastname: Kalunian
authors.forename: J B
authors.initials: JB
authors.lastname: Peter
authors.forename: H R
authors.initials: HR
authors.lastname: Middlekauff
authors.forename: J
authors.initials: J
authors.lastname: Sayre
authors.forename: D G
authors.initials: DG
authors.lastname: Ando
authors.forename: M
authors.initials: M
authors.lastname: Mangotich
authors.forename: B H
authors.initials: BH
authors.lastname: Hahn
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies / Q000032:analysis*; D002308:Cardiolipins / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005313:Fetal Death / Q000150:complications; D006801:Humans; D007132:Immunoglobulin Isotypes / Q000032:analysis; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy / Q000276:immunology* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D013927:Thrombosis / Q000150:complications
chemical_list: D000906:Antibodies; D002308:Cardiolipins; D007132:Immunoglobulin Isotypes