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.
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: B Meczekalski; A Czyzyk; M Kunicki; A Podfigurna-Stopa; L Plociennik; G Jakiel; M Maciejewska-Jeske; K Lukaszuk Journal: J Endocrinol Invest Date: 2016-06-14 Impact factor: 4.256
Authors: Hang Wun Raymond Li; David Mark Robertson; Chris Burns; William Leigh Ledger Journal: Front Endocrinol (Lausanne) Date: 2021-05-24 Impact factor: 5.555
Authors: Kelly-Anne Phillips; Ian M Collins; Roger L Milne; Sue Anne McLachlan; Michael Friedlander; Martha Hickey; Catharyn Stern; John L Hopper; Richard Fisher; Gordon Kannemeyer; Sandra Picken; Charmaine D Smith; Thomas W Kelsey; Richard A Anderson Journal: Hum Reprod Date: 2016-05 Impact factor: 6.918