Evaluation of biological variation data of Anti-Mullerian Hormone in men

Objective: This study aimed to determine within-subject (CVI) and between-subject (CVG) biological variation data for serum Anti-Müllerian Hormone (AMH) in healthy male subjects. These data were subsequently utilized to calculate individuality index (II), reference change values (RCV), and analytical performance specifications (APS). Materials and Methods: This study planned in accordance with the Standard for Reporting Biological Variation Data Studies (STARBIV) guideline determined by the Biological Variation Working Group (BV-WG) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Venous blood specimens were collected from 21 healthy male subjects aged 22–38 years once weekly for four consecutive weeks between 08:00-10:00 hours. Preanalytical sources of variation were minimized, and sera were stored at -80°C. To ensure analytical precision, analyses were performed on a Roche Cobas e601 analyzer using electrochemiluminescence immunoassay with reagents from a single lot, processed randomly in duplicate. Results: For AMH in males, CVI was 3.50% (95% CI: 2.93–4.30) and CVG was 34.72% (95% CI: 26.38–50.75). The individuality index was 0.1. Symmetric and asymmetric RCVs were ±10.23% and +10.8%/-9.7%, respectively. Desirable analytical performance specifications were imprecision <1.75%, bias <8.72%, and total allowable error <11.61%. Conclusion: The low CVI for AMH in males indicates stringent homeostatic regulation. The low II (II<0.6) signifies high individuality, suggesting RCV utilization is more appropriate than population-based reference intervals for clinical monitoring. To the best of our knowledge, this represents the first comprehensive study reporting AMH biological variation data in males within the existing literature.