title: Performance characteristics of the Access AMH assay for the quantitative determination of anti-Müllerian hormone (AMH) levels on the Access* family of automated immunoassay systems.
abstract: OBJECTIVE
  Anti-Müllerian hormone (AMH) measurement is useful as an aid in the evaluation of ovarian reserve. In the past, its conventional use was restricted by the low-throughput and variability of existing manual AMH assays. We developed the automated Access AMH assay for the quantitative determination of AMH levels on the Access family of immunoassay systems. The analytical performance of this new assay was evaluated.
  
  
  METHODS
  Sensitivity, dilution linearity, assay imprecision, AMH sample stability, lot-to-lot comparison and correlation with AMH Gen II assay (Beckman Coulter, Inc.) were evaluated. Reference intervals for Access AMH were established in healthy females, males, newborns (≤60days) and pediatric males classified by Tanner stages.
  
  
  RESULTS
  The limit of blank and limit of detection were below 0.0077 and 0.0098ng/mL, respectively. The limit of quantitation was 0.010ng/mL. The total imprecision ranged from 2.4 to 5.2%. Linearity was observed up to 24ng/mL. Sample storage at room temperature up to 48h, at 2-8°C up to 7days and at -20°C up to 15months had no impact on measured AMH. The correlation study gave a coefficient between 0.99 and 1 and a regression slope between 0.89 and 0.92. Excellent lot-to-lot comparability was observed on controls and patient samples with a maximum bias of 3.7% between 2.81 and 15.03ng/mL.
  
  
  CONCLUSIONS
  The fully automated Access AMH immunoassay demonstrates excellent analytical performance. As a consequence, the availability of this assay will represent a robust, fast and precise alternative to manual AMH assay testing.
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: gdemirdjian@beckman.com.
authors.forename: Gaiane
authors.initials: G
authors.lastname: Demirdjian
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: sbord@beckman.com.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Bord
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: clejeune@beckman.com.
authors.forename: Caroline
authors.initials: C
authors.lastname: Lejeune
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division, Chaska Campus 1000 Lake Hazeltine Drive, Chaska, MN 55318, United States. Electronic address: rjmasica@beckman.com.
authors.forename: Ryan
authors.initials: R
authors.lastname: Masica
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: driviere@beckman.com.
authors.forename: Dominique
authors.initials: D
authors.lastname: Rivière
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: lnicouleau@beckman.com.
authors.forename: Lucie
authors.initials: L
authors.lastname: Nicouleau
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: pdenizot@beckman.com.
authors.forename: Philippe
authors.initials: P
authors.lastname: Denizot
authors.affiliation: Beckman Coulter, Inc., Diagnostic Division 130, avenue de Lattre de Tassigny, Marseille 13009, France. Electronic address: pmarquet@beckman.com.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Marquet
mesh_terms: D054304:Anti-Mullerian Hormone / Q000097:blood*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D008297:Male; D065851:Ovarian Reserve; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D054304:Anti-Mullerian Hormone
keywords: Access AMH; Anti-Müllerian hormone (AMH); Automated AMH assay; Beckman Coulter; Lot-to-lot variability; Ovarian reserve; Tanner stage