title: Specificity and predictive value of circulating testosterone assessed by tandem mass spectrometry for the diagnosis of polycystic ovary syndrome by the National Institutes of Health 1990 criteria.
abstract: OBJECTIVE
  To determine whether liquid chromatography-tandem mass spectrometry (LC-MS/MS) determination of total (TT) and free (FT) testosterone is more specific than extraction chromatography-radioimmunoassay (RIA) for distinguishing women with polycystic ovary syndrome (PCOS) from controls and whether differing cutoff values should be used depending on the setting.
  
  
  METHODS
  Prospective case-control cohort study.
  
  
  METHODS
  Tertiary care center and reference laboratory.
  
  
  METHODS
  Blood sampling.
  
  
  METHODS
  One hundred patients with PCOS and 100 controls.
  
  
  METHODS
  Circulating TT measured by RIA and LC-MS/MS and FT measured by equilibrium dialysis using RIA or LC-MS/MS-generated TT values.
  
  
  RESULTS
  T measurement by RIA and LC-MS/MS similarly differentiated patients with PCOS from controls; detection of PCOS was higher for FT for both methods. TT values demonstrated greater overlap between patients with PCOS and controls than did FT for both RIA (80% vs. 42% overlap) and LC-MS/MS (52% vs. 67% overlap). A lower cutoff value by LC-MS/MS was better suited for the study of patients seen in the clinical (referred) setting (35 and 4.0 ng/dL for TT and FT, respectively) than in the screening of a general population (50 and 5.0 ng/dL for TT and FT, respectively).
  
  
  CONCLUSIONS
  Extraction chromatography-RIA and LC-MS/MS measurements of T have similar performance for differentiating patients with PCOS from healthy controls; LC-MS/MS may be preferable given its relative ease of automation. Compared with FT, measurement of TT has relatively limited value for distinguishing PCOS from normal. Finally, different cutoff values should be considered depending on the clinical/investigative setting, with higher values being used in the study of biased (e.g., clinical or referred) populations.
authors.affiliation: Quest Diagnostics Nichols Institute, San Juan Capistrano, California.
authors.forename: Wael A
authors.initials: WA
authors.lastname: Salameh
authors.affiliation: Quest Diagnostics Nichols Institute, San Juan Capistrano, California.
authors.forename: Mildred M
authors.initials: MM
authors.lastname: Redor-Goldman
authors.affiliation: Quest Diagnostics Nichols Institute, San Juan Capistrano, California.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Clarke
authors.affiliation: Department of Ob/Gyn and Center for Androgen Related Disorders, Cedars Sinai Medical Center, Los Angeles, California; Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Ruchi
authors.initials: R
authors.lastname: Mathur
authors.affiliation: Department of Ob/Gyn and Center for Androgen Related Disorders, Cedars Sinai Medical Center, Los Angeles, California. Electronic address: President@GRU.edu.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Azziz
authors.affiliation: Quest Diagnostics Nichols Institute, San Juan Capistrano, California.
authors.forename: Richard E
authors.initials: RE
authors.lastname: Reitz
mesh_terms: D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D002853:Chromatography, Liquid / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D008875:Middle Aged; D011085:Polycystic Ovary Syndrome / Q000097:blood* / Q000175:diagnosis*; D017410:Practice Guidelines as Topic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013739:Testosterone / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D013739:Testosterone
keywords: Polycystic ovary syndrome; androgens; mass spectrometry; radioimmunoassays; testosterone