title: Comparison of two different methods for measuring anti-mullerian hormone in a clinical series.
abstract: BACKGROUND
  Anti Mullerian hormone (AMH) has previously been measured using a manual method, but a fully automated assay from Roche Diagnostics was recently introduced. The aim of this study was to compare the results from the AMH gen II ELISA and Elecsys Cobas AMH methods in a clinical setting to evaluate whether the assays achieve the goals of analytical performance. A prospective observational study with 23 women seeking laparoscopic sterilization was conducted. Blood samples were collected preoperatively as well as 1 week and 1, 3 and 6 months postoperatively; they were evaluated with the AMH gen II ELISA and Elecsys Cobas AMH methods. The assays were validated according to the optimal performance of biochemical assays: CV Analytical < 0.25* CV Within Biological Variation.
  
  
  RESULTS
  We found a good correlation between the two methods; there was a bias of approximately 32 %. The total within-person biological variability ranged from approximately 21 to 32 %. The analytical variability of the AMH gen II ELISA and Elecsys Cobas methods ranged from 5.5 to 10.3 % and 2.8 to 3.3 %, respectively. Applying the goals for optimal assay performance, the Elecsys Cobas method achieved optimal performance throughout the measuring range, whereas the AMH Gen II only achieved optimal performance in the high end of the measuring range. Furthermore, the Elecsys Cobas assay had a low limit of quantitation of 0.5 pmol/l compared to 3.0 pmol/l for the AMH gen II ELISA.
  
  
  CONCLUSIONS
  In the clinical setting, the Elecsys Cobas AMH assay performs well according to the optimal standard for biochemical assays.
authors.affiliation: Department of Obstetrics and Gynecology, Regional Hospital of Randers, Randers, Denmark.|Department of Clinical Biochemistry, Aarhus University Hospital, Skejby Palle Juul-Jensens Boulevard 99, DK-8200, Aarhus, Denmark.
authors.forename: Josephine
authors.initials: J
authors.lastname: Hyldgaard
authors.affiliation: Department of Obstetrics and Gynecology, Regional Hospital of Randers, Randers, Denmark.
authors.forename: Pinar
authors.initials: P
authors.lastname: Bor
authors.affiliation: The Fertility Clinic, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Hans Jakob
authors.initials: HJ
authors.lastname: Ingerslev
authors.affiliation: Department of Clinical Biochemistry, Aarhus University Hospital, Skejby Palle Juul-Jensens Boulevard 99, DK-8200, Aarhus, Denmark. nieltoer@rm.dk.
authors.forename: Niels
authors.initials: N
authors.lastname: Tørring
mesh_terms: D000328:Adult; D054304:Anti-Mullerian Hormone / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D010535:Laparoscopy; D011446:Prospective Studies
chemical_list: D054304:Anti-Mullerian Hormone