Abstract:

Objective To investigate the long-term biological variation of 7 serum sex hormones during female follicular phase in Shanghai，and to derive the performance specification based on biological variation. Methods A total of 64 volunteers（non-pregnant females aged 20-40 years old）were enrolled from the International Peace Maternal and Child Health Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Peripheral blood samples were collected on the 2nd or 3rd day of menstruation of each volunteer every month for 6 months. The 7 serum sex hormones [anti-Müllerian hormone（AMH），estradiol（E2），follicle-stimulating hormone（FSH），luteinizing hormone（LH），prolactin（PRL），progesterone（Prog）and testosterone（Testo）] were determined. The allowable imprecision，allowable deviation and allowable total error of the 3 levels of "best"，"appropriate" and "lowest" were derived according to the relevant formulas. Results Compared with European Federation of Clinical Chemistry and Laboratory Medicine（EFLM）database，Prog，Testo intra-individual coefficient of variation（CV_I）and inter-individual coefficient of variation（CV_G），FSH CV_I were compared with existing data，and there was no statistical significance（P>0.05）. CV_I and CV_G of E2 were higher than the existing data（P<0.01），CV_I and CV_G of PRL and LH，CV_G of FSH and CV_I of AMH were lower than the existing data（P<0.01），and no CV_G of AMH had ever been reported. Conclusions Long-term biological variation data of 7 serum sex hormones of females in Shanghai has been determined. It can provide a performance specification based on the biological variation of the population in Shanghai.

Key words: Sex hormone, Follicular phase, Biological variation, Performance specification, Shanghai