Paediatric Anti‐Müllerian Hormone measurement: Male and female reference intervals established using the automated Beckman Coulter Access AMH assay

Abstract

Summary Objective Anti‐Müllerian Hormone (AMH) concentration is high at birth in males, demonstrating the presence of functional testicular tissue in the prepubertal period, and acting as a useful marker in the investigation of paediatric reproductive disorders. AMH also provides a tool in the investigation of female virilization, premature ovarian failure and polycystic ovarian syndrome in childhood. Robust, assay‐specific paediatric AMH reference intervals are therefore required for clinical interpretation of results. The aim of this study was to derive age‐specific AMH reference intervals for males and females aged 0‐18 years. Design and Patients Plasma samples were obtained from patients at Royal Manchester Children's Hospital and analysed for AMH using the automated Beckman Coulter Access AMH Assay. Patients under investigation for paediatric reproductive or endocrine disorders were excluded from the study. Measurements Seven hundred and 2 patient plasma samples (465 male, 237 female) were subject to AMH measurement, and results were analysed in order to derive continuous and discrete reference intervals for the paediatric age range. Results Clear discrimination between male and female AMH results was evident in the prepubertal age range, with some overlap between the genders following pubertal onset. Conclusions We have derived age‐related reference intervals for plasma AMH in the paediatric age range (0‐18 years) using the automated Beckman Coulter Access AMH assay which will aid in the investigation of paediatric endocrine disorders such as disorders of sexual development.

Paediatric reference intervals for plasma anti-Müllerian hormone: comparison of data from the Roche Elecsys assay and the Beckman Coulter Access assay using the same cohort of samples

“…The quantile regression model for the male cohort of samples analysed using the Roche Elecsys AMH assay was very similar to the model obtained previously 17 using the Beckman Coulter Access AMH data; there was a high concentration of AMH at birth, increasing to a peak within the first year of life before falling gradually, plateauing during infancy and then decreasing further from age 10 to 12 years. The model in females using the Roche Elecsys data was smoother than that previously modelled with the Beckman Coulter Access AMH values.…”

“…Chronological sample flow chart. Chronological flow chart showing the sample numbers collected in the paediatric cohort, how many were previously assayed using the Beckman Coulter Access AMH assay, 17 how many were available for the Roche Elecsys AMH assay and how many of these samples had both a valid (i.e. a reportable value above the LOQ) Roche Elecsys result and Beckman Coulter Access result to enable direct comparison.…”

“…A total of 1066 unselected lithium heparin plasma samples (623 phenotypically male and 443 phenotypically female) were collected from patients aged between 1 day and 18 years over a six-month period from surplus routine samples sent to the biochemistry department at MFT as described previously. 17 As this was a method development study utilizing anonymized surplus acellular plasma marked for disposal from routinely requested samples explicit consent was not required (further information is available at https://www.hta.gov.uk/). Samples were allocated a study number and frozen at −80°C for up to two years.…”

“…Following our validation of the Roche Elecsys AMH assay against our previous service assay the Beckman Coulter modified Gen II AMH assay using samples from adult females, the primary aim of this study was to derive full paediatric age- and gender-related reference ranges for AMH using the Roche Elecsys assay on the Cobas e602 autoanalyser and to compare these AMH values to those obtained previously on the same cohort of paediatric samples using the Beckman Coulter Access assay. 17 Finally, paediatric male and female AMH using values generated on samples which had both a valid Roche Elecsys and previously measured Beckman Coulter Access AMH value were directly compared.…”

“…16 reported partial paediatric reference intervals using the Beckman Coulter Access AMH assay and we have recently reported comprehensive reference range data on a paediatric cohort of samples using the Beckman Coulter Access AMH with the Beckman Coulter DxI 800 autoanalyser. 17…”