title: First fully automated immunoassay for anti-Müllerian hormone.
abstract: BACKGROUND
  The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.
  
  
  METHODS
  Development of a high sensitive, fast and fully automated AMH assay on the Elecsys®/cobas e electrochemiluminescence immunoassay platform.
  
  
  RESULTS
  Elecsys® AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys® AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20-25 °C or 2-8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at -20 °C and -80 °C for up to 9 months was without any effect on measured AMH.
  
  
  CONCLUSIONS
  Availability of an automated Elecsys® AMH assay offers an attractive alternative to the current manual AMH assays.
authors.forename: Dieter
authors.initials: D
authors.lastname: Gassner
authors.forename: Rebecca
authors.initials: R
authors.lastname: Jung
mesh_terms: D054304:Anti-Mullerian Hormone / Q000378:metabolism*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D054304:Anti-Mullerian Hormone