Ormone anti-Mülleriano tra evidence-based medicine e medicina di laboratorio

Studies and articles have been devoted to automated methods that have replaced first-generation manual methods for measuring anti-Müllerian hormone (AMH) and its role in the management of polycystic ovary syndrome (PCOS). The vast majority of laboratories use automated analyzers, and three have received FDA clearance for a cutoff of 1.77 ng/ml to discriminate an antral follicle count >15, even though sensitivity, specificity, likelihood ratio (LR)+ and LR- were modest. The difficulty in measuring AMH stems from the synthesis of the molecule itself, which undergoes cleavages that produce, in addition to the AMHN/C complex, the most potent bioactive form for optimal binding to the AMH II receptor, the bioactive C-terminal fragment, intermediate molecules and inactive fragments such as the N-terminal. The methods and analyzers available measure both active and inactive molecules, which are present in varying proportions of isoforms in different subjects and clinical contexts. AMH has been proposed for assessing ovarian reserve before and after stimulation and as a diagnostic marker for PCOS to supplement the Rotterdam criteria, given that AMH increases two- to threefold. The Elecsys AMH Plus reagent has obtained FDA 510(k) clearance and CE marking for the PCOS cut-off of 3.2 ng/mL. The conclusions of the International Evidence-Based Guideline for the assessment and management of polycystic ovary syndrome 2023 appear to be a reference point; the section on AMH summarises in a few hundred words the recommendations that are codified as EBR, CR or PP depending on whether they are evidence-based, Consensus or Practical Points, respectively.