A multicentre evaluation of the Elecsys ® anti-Müllerian hormone immunoassay for prediction of antral follicle count

Michael H. Jacobs, Laura M. Reuter, Valerie Baker, La Tasha B. Craig, Denny Sakkas, Eric Surrey, Kevin J. Doody, Emily S. Jungheim, Aykut B. Bayrak, Martin Hund, Wilma D.J. Verhagen-Kamerbeek, Deborah Pardue, Katharina Buck, Barbara Timm

Research output: Contribution to journalArticle

Abstract

Research question: What concentration of anti-Müllerian hormone (AMH) corresponds to an antral follicle count (AFC) >15 for determination of ovarian reserve? Design: A prospective study conducted at 13 US fertility clinics in women aged 21–44 years who presented for AFC evaluation by transvaginal ultrasound. Serum samples were collected at the time of AFC evaluation (menstrual cycle day 2–4). AMH concentrations were measured by the Elecsys ® AMH immunoassay; oestradiol and follicle-stimulating hormone (FSH) concentrations were also measured. The serum AMH cut-off able to detect AFC >15 with high sensitivity was determined (derivation cohort). Clinical performance of the AMH assay at the derived cut-off was evaluated (validation cohort). Receiver operating characteristic (ROC) analyses were also performed. Results: In the derivation cohort (n = 306), an optimal serum AMH cut-off value of 1.77 ng/ml was determined to correspond to AFC >15 with 89.63% sensitivity and 69.01% specificity, using the Elecsys AMH assay. In the validation cohort (n = 856), this 1.77 ng/ml cut-off could identify women with an AFC >15 with a sensitivity of 88.34% and a specificity of 68.29%; corresponding positive predictive and negative predictive values were 75.19% and 84.34%, respectively. ROC analyses demonstrated that AMH performed better than oestradiol or FSH in predicting AFC, with area under the curves of 85.7%, 57.1% and 69.7%, respectively, in the validation cohort. Conclusion: The Elecsys AMH immunoassay provides a robust and fully automated method to measure serum AMH levels. Women with AMH values below the cut-off of 1.77 ng/ml are unlikely to have AFC >15.

Original languageEnglish (US)
Pages (from-to)845-852
Number of pages8
JournalReproductive BioMedicine Online
Volume38
Issue number5
DOIs
StatePublished - May 1 2019
Externally publishedYes

Fingerprint

Immunoassay
Hormones
Follicle Stimulating Hormone
Serum
ROC Curve
Estradiol
Antral
Menstrual Cycle
Area Under Curve
Fertility
Prospective Studies
Sensitivity and Specificity

Keywords

  • Anti-Müllerian hormone
  • Antral follicle count
  • Ommunoassay
  • Ovarian reserve

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Developmental Biology

Cite this

A multicentre evaluation of the Elecsys ® anti-Müllerian hormone immunoassay for prediction of antral follicle count . / Jacobs, Michael H.; Reuter, Laura M.; Baker, Valerie; Craig, La Tasha B.; Sakkas, Denny; Surrey, Eric; Doody, Kevin J.; Jungheim, Emily S.; Bayrak, Aykut B.; Hund, Martin; Verhagen-Kamerbeek, Wilma D.J.; Pardue, Deborah; Buck, Katharina; Timm, Barbara.

In: Reproductive BioMedicine Online, Vol. 38, No. 5, 01.05.2019, p. 845-852.

Research output: Contribution to journalArticle

Jacobs, MH, Reuter, LM, Baker, V, Craig, LTB, Sakkas, D, Surrey, E, Doody, KJ, Jungheim, ES, Bayrak, AB, Hund, M, Verhagen-Kamerbeek, WDJ, Pardue, D, Buck, K & Timm, B 2019, ' A multicentre evaluation of the Elecsys ® anti-Müllerian hormone immunoassay for prediction of antral follicle count ', Reproductive BioMedicine Online, vol. 38, no. 5, pp. 845-852. https://doi.org/10.1016/j.rbmo.2018.12.041
Jacobs, Michael H. ; Reuter, Laura M. ; Baker, Valerie ; Craig, La Tasha B. ; Sakkas, Denny ; Surrey, Eric ; Doody, Kevin J. ; Jungheim, Emily S. ; Bayrak, Aykut B. ; Hund, Martin ; Verhagen-Kamerbeek, Wilma D.J. ; Pardue, Deborah ; Buck, Katharina ; Timm, Barbara. / A multicentre evaluation of the Elecsys ® anti-Müllerian hormone immunoassay for prediction of antral follicle count In: Reproductive BioMedicine Online. 2019 ; Vol. 38, No. 5. pp. 845-852.
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abstract = "Research question: What concentration of anti-M{\"u}llerian hormone (AMH) corresponds to an antral follicle count (AFC) >15 for determination of ovarian reserve? Design: A prospective study conducted at 13 US fertility clinics in women aged 21–44 years who presented for AFC evaluation by transvaginal ultrasound. Serum samples were collected at the time of AFC evaluation (menstrual cycle day 2–4). AMH concentrations were measured by the Elecsys {\circledR} AMH immunoassay; oestradiol and follicle-stimulating hormone (FSH) concentrations were also measured. The serum AMH cut-off able to detect AFC >15 with high sensitivity was determined (derivation cohort). Clinical performance of the AMH assay at the derived cut-off was evaluated (validation cohort). Receiver operating characteristic (ROC) analyses were also performed. Results: In the derivation cohort (n = 306), an optimal serum AMH cut-off value of 1.77 ng/ml was determined to correspond to AFC >15 with 89.63{\%} sensitivity and 69.01{\%} specificity, using the Elecsys AMH assay. In the validation cohort (n = 856), this 1.77 ng/ml cut-off could identify women with an AFC >15 with a sensitivity of 88.34{\%} and a specificity of 68.29{\%}; corresponding positive predictive and negative predictive values were 75.19{\%} and 84.34{\%}, respectively. ROC analyses demonstrated that AMH performed better than oestradiol or FSH in predicting AFC, with area under the curves of 85.7{\%}, 57.1{\%} and 69.7{\%}, respectively, in the validation cohort. Conclusion: The Elecsys AMH immunoassay provides a robust and fully automated method to measure serum AMH levels. Women with AMH values below the cut-off of 1.77 ng/ml are unlikely to have AFC >15.",
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AU - Jacobs, Michael H.

AU - Reuter, Laura M.

AU - Baker, Valerie

AU - Craig, La Tasha B.

AU - Sakkas, Denny

AU - Surrey, Eric

AU - Doody, Kevin J.

AU - Jungheim, Emily S.

AU - Bayrak, Aykut B.

AU - Hund, Martin

AU - Verhagen-Kamerbeek, Wilma D.J.

AU - Pardue, Deborah

AU - Buck, Katharina

AU - Timm, Barbara

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N2 - Research question: What concentration of anti-Müllerian hormone (AMH) corresponds to an antral follicle count (AFC) >15 for determination of ovarian reserve? Design: A prospective study conducted at 13 US fertility clinics in women aged 21–44 years who presented for AFC evaluation by transvaginal ultrasound. Serum samples were collected at the time of AFC evaluation (menstrual cycle day 2–4). AMH concentrations were measured by the Elecsys ® AMH immunoassay; oestradiol and follicle-stimulating hormone (FSH) concentrations were also measured. The serum AMH cut-off able to detect AFC >15 with high sensitivity was determined (derivation cohort). Clinical performance of the AMH assay at the derived cut-off was evaluated (validation cohort). Receiver operating characteristic (ROC) analyses were also performed. Results: In the derivation cohort (n = 306), an optimal serum AMH cut-off value of 1.77 ng/ml was determined to correspond to AFC >15 with 89.63% sensitivity and 69.01% specificity, using the Elecsys AMH assay. In the validation cohort (n = 856), this 1.77 ng/ml cut-off could identify women with an AFC >15 with a sensitivity of 88.34% and a specificity of 68.29%; corresponding positive predictive and negative predictive values were 75.19% and 84.34%, respectively. ROC analyses demonstrated that AMH performed better than oestradiol or FSH in predicting AFC, with area under the curves of 85.7%, 57.1% and 69.7%, respectively, in the validation cohort. Conclusion: The Elecsys AMH immunoassay provides a robust and fully automated method to measure serum AMH levels. Women with AMH values below the cut-off of 1.77 ng/ml are unlikely to have AFC >15.

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