Receiver operating characteristic analysis of the performance of basal serum hormone profiles for the diagnosis of polycystic ovary syndrome in epidemiological studies

Objective: We have used receiver operating characteristic (ROC) analysis to determine the diagnostic performance of several serum parameters, in order to evaluate their potential usefulness in establishing the diagnosis of po lycystic ovary syndrome (PCOS) in epidemiological studies. Design: Prospective study. Methods: One hundred and fourteen women reporting spontaneously for blood d onation were included in the study. Menopausal and oral contraceptive-treat ed women were excluded. Serum samples were obtained at the moment of donati on, independently of fasting, time of day or day of menstrual cycle. Measur ements included total testosterone, sex hormone-binding globulin (SHBG), de hydroepiandrosterone sulfate (DHEAS), LE, FSH and estradiol. The free testo sterone (FT) concentration and the free androgen index (FAI) were calculate d from testosterone and SHBG levels. ROC curves were calculated for all the se serum determinations. Results: Eight patients were diagnosed with PCOS, according to the presence of oligomenorrhea, hirsutism, acne and/or hyperandrogenemia, and exclusion of non-classic congenital adrenal hyperplasia, hypothyroidism and hyperpro lactinemia. Of the parameters studied SHBG, FAI, FT and DHEAS were consider ed adequate measures for the diagnosis of PCOS. For example, serum SUBG lev els showed an area under the ROC curve of 0.875 +/- (S.E.(W))0.045 (95% con fidence interval 0.800-0.929). A SHBG decision threshold < 37 nmol/l had a sensitivity of 87.5%, a specificity of 86.8%, a positive likelihood ratio o f 6.63, and a negative likelihood ratio of 0.14, for the diagnosis of PCOS. Conclusions: Our present results strongly suggest that decreased SHBG level s, and increased FAI, free testosterone concentration and DHEAS concentrati ons, are highly effective as single analytical procedures in epidemiologica l studies for the detection of PCOS in women of reproductive age.