Head-To-Head Assessment of Diagnostic Performance of Testosterone Immunoassays in Patients With Polycystic Ovary Syndrome

J Clin Lab Anal. 2016 Sep;30(5):479-84. doi: 10.1002/jcla.21882. Epub 2015 Oct 26.


Background: Determination of plasma testosterone is critical for the proper diagnosis of polycystic ovary syndrome (PCOS), but the interpretation of biochemical tests is hampered by inadequate specificity and precision of available immunoassays. We here compared the diagnostic performance of three testosterone immunoassays (Advia Centaur, Immulite 2000 XPi, Cobas e411) in PCOS patients using receiver operator characteristics curve analysis.

Methods and results: Plasma levels of testosterone, androstendione, dehydroepiandrosterone sulfate, 17-hydroxyprogesterone, estradiol, progesterone, steroid hormone binding globulin, luteinizing hormone, and follicular stimulating hormone were determined in 188 patients with PCOS and 202 controls. Free testosterone (fT) levels and free androgen index (FAI) were calculated. Testosterone levels measured on Advia Centaur, Immulite 2000 XPi, and Cobas e411 showed clear linear relationship to each other. Testosterone measured with Advia Centaur showed discriminatory performance superior to Immulite 2000 XPi and Cobas e411. Calculation of fT or FAI improved the performance of Advia Centaur and Immulite 2000 XPi, which nevertheless performed better than Cobas e411. The performance of other parameters was inferior to that of testosterone, fT, and FAI.

Conclusion: Present study documents striking differences between testosterone immunoassays with respect to their capacity to identify PCOS patients and favors the use of calculated parameters reflecting active testosterone in plasma.

Keywords: immunoassay; polycystic ovary syndrome; receiver operating characteristic curves; testosterone.

MeSH terms

  • Female
  • Gas Chromatography-Mass Spectrometry
  • Hormones / blood
  • Humans
  • Immunoassay / instrumentation
  • Immunoassay / methods*
  • Polycystic Ovary Syndrome / blood*
  • Polycystic Ovary Syndrome / diagnosis*
  • ROC Curve
  • Retrospective Studies
  • Testosterone / blood*


  • Hormones
  • Testosterone