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Antimüllerian hormone generation II assay nomogram

      We read with great interest the article entitled “Reference range for the antimüllerian hormone Generation II assay: a population study of 10,984 women, with comparison to the established Diagnostics Systems Laboratory nomogram” by Nelson et al. (
      • Nelson S.M.
      • Iliodromiti S.
      • Fleming R.
      • Anderson R.
      • McConnachie A.
      • Messow C.M.
      Reference range for the antimüllerian hormone Generation II assay: a population study of 10,984 women, with comparison to the established Diagnostics Systems Laboratory nomogram.
      ). This excellent multicenter study found that the anticipated 40% increase in age-specific population values, relative to the previously validated Diagnostic Systems Laboratory (DSL) assay nomogram, was not observed. They concluded that age-specific reference ranges for the antimüllerian (AMH) Gen II assay suggest a systematic shift in assay calibration with the initial evaluation and commercial release of the AMH Gen II assay. These data are in accordance with other laboratories where there have also been a systematic shift in the assay from the early release versions. For example, Rustamov et al. (
      • Rustamov O.
      • Smith A.
      • Roberts S.A.
      • Yates A.P.
      • Firzgearld C.
      • Krishnan M.
      • et al.
      Anti-Mullerian hormone: poor assay reproducibility in a large cohort of subjects suggests sample instability.
      ) demonstrated data in which there was a shift downward of 20%–40% in median values compared with a predicted 40% increase from the DSL assay.
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      References

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        • Iliodromiti S.
        • Fleming R.
        • Anderson R.
        • McConnachie A.
        • Messow C.M.
        Reference range for the antimüllerian hormone Generation II assay: a population study of 10,984 women, with comparison to the established Diagnostics Systems Laboratory nomogram.
        Fertil Steril. 2014; 101: 523-529
        • Rustamov O.
        • Smith A.
        • Roberts S.A.
        • Yates A.P.
        • Firzgearld C.
        • Krishnan M.
        • et al.
        Anti-Mullerian hormone: poor assay reproducibility in a large cohort of subjects suggests sample instability.
        Hum Reprod. 2012; 27: 3085-3091
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        Variation in antimüllerian hormone concentration during the menstrual cycle may change the clinical classification of the ovarian response.
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      Linked Article

      • Reply of the Authors
        Fertility and SterilityVol. 102Issue 1
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          We are grateful for the interest shown by Łukaszuk and colleagues in our article examining the discordance in values reported by the Generation II antimüllerian (AMH) assay compared with the anticipated performance (1). As they highlight, the values obtained were substantially lower than expected, in keeping with previous reports and may have placed patients at risk of iatrogenic ovarian hyperstimulation syndrome (OHSS). Concerns regarding the robustness of the AMH Gen II ELISA assay have been further fuelled by recent safety notices and technical bulletins from Beckman Coulter indicating that undiluted samples may give falsely low values due to interference from complement, but also that some samples diluted before addition to the plate may give falsely elevated values (2).
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