Biological variation of serum Anti-Müllerian Hormone in healthy adult men


Kılınçer R. B., CANİKLİOĞLU A., Ercan M.

Clinica Chimica Acta, cilt.590, 2026 (SCI-Expanded, Scopus) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 590
  • Basım Tarihi: 2026
  • Doi Numarası: 10.1016/j.cca.2026.121068
  • Dergi Adı: Clinica Chimica Acta
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Chemical Abstracts Core, Chimica, EMBASE
  • Anahtar Kelimeler: Analytical performance specifications, Anti-Müllerian hormone, Biological variation, Healthy men, Individuality index, Reference change value
  • Yozgat Bozok Üniversitesi Adresli: Evet

Özet

Objectives Anti-Müllerian hormone (AMH) is a dimeric glycoprotein essential for male sex differentiation during embryogenesis and a widely used biomarker of testicular function in adult men. This study aimed to determine within-subject (CVI) and between-subject (CVG) biological variation data for serum AMH in healthy adult men. Methods Between November 2024 and March 2025, this Turkey-based study enrolled 20 healthy adult male volunteers selected using predefined inclusion and exclusion criteria. Blood samples were collected over four consecutive weeks, resulting in four specimens per participant. The serum AMH concentration was analyzed on a Roche Cobas e601 analyzer. Statistical analyses included outlier detection; assessment of data distribution, steady-state conditions, and homogeneity; analysis of variance with a 95% confidence interval (CI); estimation of analytical performance specifications (APSs); and calculation of the individuality index (II) and reference change value (RCV). Results CVI was 3.5% (95% CI: 2.93–4.3), while CVG was 34.72% (95% CI: 26.38–50.75) in this study. The II value was 0.1, and the asymmetrical RCV was +9% for increases and − 8.2% for decreases. Desirable APSs were imprecision <1.75%, bias <8.72%, and total allowable error < 11.61%. Conclusions The low CVI for AMH in men indicates stringent homeostatic regulation. The low II signifies high individuality, suggesting that RCV utilization is more appropriate than population-based reference intervals for clinical monitoring. To the best of our knowledge, this is the first comprehensive study reporting biological variation data for AMH in men.