Performance of the two new fully automated anti-Müllerian hormone immunoassays compared with the clinical standard assay.

STUDY QUESTION: How do the two new fully automated anti-Müllerian hormone (AMH) assays released in September 2014 by two different diagnostic companies perform compared with the clinical standard assay, namely the AMH Gen II enzyme-linked immunosorbent assay (ELISA)? SUMMARY ANSWER: Both fully automated AMH assays perform in a nearly identical fashion compared with the AMH Gen II assay, with a higher analytical sensitivity. WHAT IS KNOWN ALREADY: Owing to the lack of standardization, the results of AMH ELISA assays are sometimes difficult to compare. The BCI AMH Gen II assay became the clinical reference assay over the last few years. Two newly developed fully automated, highly sensitive AMH immunoassays, based on the AMH Gen II antibody composition have become available since September 2014. STUDY DESIGN, SIZE, DURATION: Previously characterized serum samples from 155 women were used to measure AMH with the three immunoassays, focusing on the aspect of predicting ovarian reserve. PARTICIPANTS/MATERIALS, SETTING,
METHODS: Samples from 94 women with an unfilled desire for a child diagnosed as infertile/subfertile, 29 samples women with polycystic ovary syndrome and 32 women approaching menopause were included to the study. The precision and the linearity in dilutions of the two new AMH assays were determined and the assay results were compared with the clinical reference (the modified version of the BCI AMH Gen II assay) and to the antral follicle counts of the study participants. Cutoff values for the discrimination between each of two predefined groups were calculated using receiver operating characteristic analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The performance evaluation of the fully automated AMH assays resulted in a within-run and intermediate precision of 0.9-1.9% and 2.5-6.5% with the one and 0.9-3.6% or 4.4-10.7% with the other immunoassay, respectively. Pearson's coefficient of correlation was 0.991 for the method comparison between both assays with a bias of 0.003 ng/ml and a slope of 0.97. The discrimination of the new immunoassays between subfertile women and women approaching menopause was significantly better compared with the BCI Gen II assay (87.5 versus 68.8%, P < 0.05). LIMITATIONS, REASONS FOR CAUTION: Owing to the low number of study subjects in each group, the results have to be confirmed in further studies. WIDER IMPLICATIONS OF THE
FINDINGS: The findings of the study are in good agreement with studies that used the Ultra Sensitivite AMH and the pico AMH ELISA assays. The application of AMH measurement onto an automated immunoassay platform is a major step forward, allowing health care providers rapid access to the AMH result and facilitating the adoption of AMH measurement into daily clinical practice. STUDY FUNDING/COMPETING INTERESTS: We declare no financial relationships or competing interests.