Objective: Measuring testosterone in women is challenging due to decreased sensitivity and specificity at the lower concentrations seen in women. We compared the ability of liquid chromatography tandem mass spectrometry (LC-MS/MS) and chemiluminescent immunoassay (CLIA) to measure testosterone and differentiate between PCOS and non-PCOS women with infertility.
Design. Retrospective cross-sectional study from August 2013 to November 2014.
Patients. 26 Polycystic ovarian syndrome (PCOS) patients and 40 non-PCOS patients presenting to an infertility clinic with a stored follicular phase anti-mullerian hormone sample.
Measurements. Serum testosterone measured by CLIA (Immulite) and LCMSMS (Sciex 6500)
Results. Testosterone was significantly higher in women with PCOS than non-PCOS. Passing-Bablok regression showed CLIA = 0.22 + 0.98 LC-MS/MS (95% CI for intercept -0.08 to 0.51; slope 0.62 to 1.2. Bland-Altman analysis showed a mean percentage difference of 14% with limits of agreement of -59 and 86%. Diagnostic performance using receiver operating characteristic curves did not differ (AUC 0.77 for LC-MS/MS [95% CI; 0.66-0.89] and 0.788 for CLIA [95% CI; 0.67-0.91]
Conclusions. Measurement of testosterone by LC-MS/MS and CLIA show good agreement but a large degree of scatter at the low levels seen in women. There was minimal difference in the ability of either method to differentiate between PCOS and non-PCOS patients in this population.
Disclosure statement: The authors have nothing to disclose