Background: Anti-Müllerian hormone (AMH) inhibits the in utero growth of the Müllerian structures in female fetuses. In neonates with suspected disorders of sexual development (DSDs), the presence of testicular tissues and functioning Sertoli cells can be investigated by testing for serum AMH concentration.
Objective: To evaluate the performance of two new AMH assays in a hospital laboratory.
Method: The technical performance of two new assays for AMH (Beckman Coulter and Roche) was evaluated and compared with each other using standard laboratory protocols. Serum AMH concentrations were also measured in 44 neonates with no suspected DSDs.
Results: AMH results generated by the two assays are highly comparable (Pearson correlation coefficient=0.966). Both assays were linear within their reportable ranges. Precision studies showed that coefficients of variation (CVs) at the limits of quantitation (LOQ) were <7%. In the female neonates (n=24; aged 029 days; mean age=5.9 days), AMH concentrations (Beckman Coulter assay) ranged from 0.02 to 2.28 ng/ml (mean±S.D., 0.22±0.47 ng/ml). In comparison, in the male neonates (n=20; aged 030 days; mean age=11.7 days), AMH concentrations ranged from 15.5 to 157.6 ng/ml (mean±S.D., 70.5±48.7 ng/ml).
Conclusion: There is no overlap between serum AMH concentrations in the two gender groups of neonates. All AMH concentrations measured in the male and female neonates fall within their respective reference intervals provided by one of the manufacturers (males <60 days, 15.1266.6 ng/ml; females <60 days, 0.013.39 ng/ml). In conclusion, both AMH assays were analytically sensitive enough to be used in neonates, and differential AMH concentrations in male and female neonates render this test a useful tool for the investigation of DSDs.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology