Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

See all formats and pricing
More options …
Volume 52, Issue 8


First fully automated immunoassay for anti-Müllerian hormone

Dieter Gassner / Rebecca Jung
Published Online: 2014-03-13 | DOI: https://doi.org/10.1515/cclm-2014-0022


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.

Keywords: anti-Müllerian hormone (AMH); AMH enzyme-linked immunosorbent assay (ELISA); automated AMH assay


  • 1.

    Durlinger AL, Visser JA, Themmen AP. Regulation of ovarian function: the role of Anti-Mullerian hormone. Reproduction 2002;124:601–9.PubMedCrossrefGoogle Scholar

  • 2.

    Hansen KR, Hodnett GM, Knowlton N, Craig LB. Correlation of ovarian reserve tests with histologically determined primordial follicle number. Fertil Steril 2011;95:170–5.CrossrefWeb of SciencePubMedGoogle Scholar

  • 3.

    Kevenaar ME, Meerasahib MF, Kramer P, van de Lang-Born BM, de Jong FH, Groome NP, et al. Serum anti-mullerian hormone levels reflect the size of the primordial follicle pool in mice. Endocrinology 2006;147:3228–34.Google Scholar

  • 4.

    Visser JA, de Jong FH, Laven JS, Themmen PN. Anti-müllerian hormone: a new marker for ovarian function. Reproduction 2006;131:1–9.Google Scholar

  • 5.

    La Marca A, Broekmans FJ, Volpe A, Fauser BC, Macklon NS. Anti-müllerian hormone (AMH): what do we still need to know? Hum Reprod 2009;24:2264–75.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 6.

    Anderson RA, Nelson SM, Wallace WH. Measuring anti-müllerian hormone for the assessment of ovarian reserve: when and for whom is it indicated? Maturitas 2012;71:28–33.Web of ScienceCrossrefPubMedGoogle Scholar

  • 7.

    van Rooij IA, Broekmans FJ, te Velde ER, Fauser BC, Bancsi LF, de Jong FH, et al. Serum anti-Mullerian hormone levels: a novel measure of ovarian reserve. Hum Reprod 2002;17:3065–71.CrossrefGoogle Scholar

  • 8.

    Nardo LG, Gelbaya TA, Wilkinson H, Roberts SA, Yates A, Pemberton P, et al. Circulating basal anti-Müllerian hormone levels as predictor of ovarian response in women undergoing ovarian stimulation for in vitro fertilization. Fertil Steril 2009;92:1586–93.CrossrefPubMedGoogle Scholar

  • 9.

    La Marca A, Sighinolfi G, Radi D, Argento C, Baraldi E, Artenisio AC et al. Anti-mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update 2010;16:113–30.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 10.

    Nelson SM. Biomarkers of ovarian response: current and future applications. Fertil Steril 2013;99:963–9.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 11.

    Pepinsky RB, Sinclair LK, Chow EP, Mattaliano RJ, Manganaro TF, Donahoe PK, et al. Proteolytic processing of mullerian inhibiting substance produces a transforming growth factor-β-like fragment. J Biol Chem 1988;263:18961–4.Google Scholar

  • 12.

    Lee MM, Donahoe PK. Mullerian inhibiting substance, a gonadal hormone with multiple functions. Endocr Rev 1993;14:152–64.PubMedGoogle Scholar

  • 13.

    Nachtigal MW, Ingraham HA. Bioactivation of müllerian inhibiting substance during gonadal development by a kex2/subtilisin-like endoprotease. Proc Natl Acad Sci USA 1996;93:7711–6.CrossrefGoogle Scholar

  • 14.

    Di Clemente N, Jamin SP, Lugovskoy A, Carmillo P, Ehrenfels C, Picard JY, et al. Processing of anti-müllerian hormone regulates receptor activation by a mechanism distinct from TGF-β. Mol Endocrinol 2010;24:2193–206.PubMedCrossrefGoogle Scholar

  • 15.

    Wilson C, di Clemente N, Ehrenfels C, Pepinsky RB, Josso N, Vigier B, et al. Mullerian inhibiting substance requires its N-terminal domain for maintenance of biological activity, a novel finding within the transforming growth factor-β superfamily. Mol Endocrinol 1993;7:247–57.Google Scholar

  • 16.

    Kumar A, Kalra B, Patel A, McDavid L, Roudebush WE. Development of a second generation anti-Müllerian hormone (AMH) ELISA. J Immunol Meth 2010;363:51–9.Google Scholar

  • 17.

    Nelson SM, La Marca A. The journey from the old to the new AMH assay: how to avoid getting lost in the values. Reprod BioMed Online 2011;23:411–20.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 18.

    Rustamov O, Smith A, Roberts SA, Yates AP, Fitzgerald C, Krishnan M, et al. Anti-Müllerian hormone: poor assay reproducibility in a large cohort of subjects suggests sample instability. Hum Reprod 2012;27:3085–91.Web of ScienceCrossrefGoogle Scholar

  • 19.

    Zuvela E, Walls M, Matson P. Within-laboratory and between-laboratory variability in the measurement of anti-müllerian hormone determined within an external quality assurance scheme. Reprod Biology 2013;13:255–7.CrossrefWeb of ScienceGoogle Scholar

  • 20.

    Groome NP, Cranfield M, Themmen AP, Savjani GV, Mehta K, editors. Immunological assay and antibodies for anti-Mullerian hormone. United States Patent 7,897,350. Filed: 24 May, 2006.Google Scholar

  • 21.

    Pankhurst MW, McLennan IS. Human blood contains both the uncleaved precursor of anti-Müllerian hormone and a complex of the NH2-and COOH-terminal peptides. Am J Physiol Endocrinol Metab 2013;305:1241–7.Web of ScienceGoogle Scholar

  • 22.

    Clark CA, Laskin CA, Cadesky K. Anti-Mullerian hormone: reality check. Hum Reprod 2014;29:184–5.CrossrefPubMedGoogle Scholar

  • 23.

    Fleming R, Fairbairn C, Blaney C, Lucas D, Gaudoin M. Stability of AMH measurement in blood and avoidance of proteolytic changes. Reprod BioMed Online 2012;26:130–2.PubMedWeb of ScienceGoogle Scholar

About the article

Corresponding author: Dr. Dieter Gassner, Roche Diagnostics GmbH DXR-IF Nonnenwald 2 82377 Penzberg, Germany, Phone: +49 8856 603318, Fax: +49 8856 603176, E-mail:

Received: 2013-11-30

Accepted: 2014-02-14

Published Online: 2014-03-13

Published in Print: 2014-08-01

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 52, Issue 8, Pages 1143–1152, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0022.

Export Citation

©2014 by Walter de Gruyter Berlin/Boston.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

Laura Melado, Barbara Lawrenz, Junard Sibal, Emmanuel Abu, Carol Coughlan, Alfredo T. Navarro, and Human Mousavi Fatemi
Frontiers in Endocrinology, 2018, Volume 9
Leif Bungum, Julia Tagevi, Ligita Jokubkiene, Mona Bungum, Aleksander Giwercman, Nick Macklon, Claus Yding Andersen, Tobias Wirenfeldt Klausen, Niels Tørring, Ajay Kumar, and Sven Olaf Skouby
Frontiers in Endocrinology, 2018, Volume 9
Annelien C. de Kat, W. Monique Verschuren, Marinus J.C. Eijkemans, Frank J.M. Broekmans, and Yvonne T. van der Schouw
Circulation, 2017, Volume 135, Number 6, Page 556
Jackie MC Ferguson, David Pépin, Chinwe Duru, Paul Matejtschuk, Patricia K Donahoe, and Chris J Burns
Reproductive BioMedicine Online, 2018
Marleen van den Berg, Marloes van Dijk, Julianne Byrne, Helen Campbell, Claire Berger, Anja Borgmann-Staudt, Gabriele Calaminus, Uta Dirksen, Jeanette F. Winther, Sophie D. Fossa, Desiree Grabow, Victoria L. Grandage, Marry M. van den Heuvel-Eibrink, Melanie Kaiser, Tomas Kepak, Leontien C. Kremer, Jarmila Kruseova, Claudia E. Kuehni, Cornelis B. Lambalk, Flora E. van Leeuwen, Alison Leiper, Dalit Modan-Moses, Vera Morsellino, Claudia Spix, Peter Kaatsch, and Eline van Dulmen-den Broeder
JMIR Research Protocols, 2018
Gail Whiting, Jackie Ferguson, Min Fang, David Pepin, Patricia Donahoe, Paul Matejtschuk, Chris Burns, and Jun X. Wheeler
Analytical Biochemistry, 2018
Stamatina Iliodromiti, Barbara Salje, Didier Dewailly, Craig Fairburn, Renato Fanchin, Richard Fleming, Hang Wun Raymond Li, Krzysztof Lukaszuk, Ernest Hung Yu Ng, Pascal Pigny, Teddy Tadros, Joseph van Helden, Ralf Weiskirchen, and Scott M. Nelson
Human Reproduction, 2017, Volume 32, Number 8, Page 1710
Anne-Sofie Korsholm, Kathrine Birch Petersen, Janne Gasseholm Bentzen, Linda Maria Hilsted, Anders Nyboe Andersen, and Helene Westring Hvidman
Reproductive BioMedicine Online, 2018
Massimo Giusti, Miranda Mittica, Paola Comite, Claudia Campana, Stefano Gay, and Michele Mussap
Endocrine, 2018
Sokratis Stoumpos, Jennifer Lees, Paul Welsh, Martin Hund, Colin C. Geddes, Scott M. Nelson, and Patrick B. Mark
Reproductive BioMedicine Online, 2017
M. Peigné, G. Robin, S. Catteau-Jonard, P. Giacobini, D. Dewailly, and P. Pigny
Gynécologie Obstétrique Fertilité & Sénologie , 2017
Yoshimasa Asada, Yoshiharu Morimoto, Yoshiharu Nakaoka, Takahiro Yamasaki, Yutaka Suehiro, Hikaru Sugimoto, Masayuki Yoshida, and Minoru Irahara
Reproductive Medicine and Biology, 2017
Xinqi Cheng, Qiong Zhang, Min Liu, Shijun Li, Zhihua Tao, Kiyoshi Ichihara, Songlin Yu, Kai Zhang, Pengchang Li, Jianhua Han, and Ling Qiu
Clinica Chimica Acta, 2017, Volume 474, Page 70
Lukasz Plociennik, Scott M. Nelson, Aron Lukaszuk, Michal Kunicki, Agnieszka Podfigurna, Blazej Meczekalski, and Krzysztof Lukaszuk
Gynecological Endocrinology, 2017, Page 1
Alberto Pacheco, María Cruz, and Juan Antonio García Velasco
Current Opinion in Obstetrics and Gynecology, 2017, Volume 29, Number 3, Page 131
Anders Nyboe Andersen, Scott M. Nelson, Bart C.J.M. Fauser, Juan Antonio García-Velasco, Bjarke M. Klein, Joan-Carles Arce, Herman Tournaye, Petra De Sutter, Wim Decleer, Alvaro Petracco, Edson Borges, Caio Parente Barbosa, Jon Havelock, Paul Claman, Albert Yuzpe, Hana Višnová, Pavel Ventruba, Petr Uher, Milan Mrazek, Anders Nyboe Andersen, Ulla Breth Knudsen, Didier Dewailly, Anne Guivarc'h Leveque, Antonio La Marca, Enrico Papaleo, Waldemar Kuczynski, Katarzyna Kozioł, Margarita Anshina, Irina Zazerskaya, Alexander Gzgzyan, Elena Bulychova, Victoria Verdú, Pedro Barri, Juan Antonio García-Velasco, Manuel Fernández-Sánchez, Fernando Sánchez Martin, Ernesto Bosch, José Serna, Gemma Castillon, Rafael Bernabeu, Marcos Ferrando, Stuart Lavery, Marco Gaudoin, Scott M. Nelson, Bart C.J.M. Fauser, Bjarke M. Klein, Lisbeth Helmgaard, Bernadette Mannaerts, and Joan-Carles Arce
Fertility and Sterility, 2017, Volume 107, Number 2, Page 387
H.W.R. Li, B.P.C. Wong, W.K. Ip, W.S.B. Yeung, P.C. Ho, and E.H.Y. Ng
Human Reproduction, 2016, Volume 31, Number 12, Page 2796
Teddy Tadros, Bruno Tarasconi, Jean Nassar, Jean-Luc Benhaim, Joëlle Taieb, and Renato Fanchin
Fertility and Sterility, 2016, Volume 106, Number 7, Page 1800
Estefanía Capecce, Melina Pelanda, Mariana Dicugno, Eduardo González de Sampaio, Graciela Buongiorno, Nora Corazza, Matías Peñaloza, Ana María Sequera, and Gabriela Ruibal
Revista Argentina de Endocrinología y Metabolismo, 2016, Volume 53, Number 3, Page 106
B. Meczekalski, A. Czyzyk, M. Kunicki, A. Podfigurna-Stopa, L. Plociennik, G. Jakiel, M. Maciejewska-Jeske, and K. Lukaszuk
Journal of Endocrinological Investigation, 2016, Volume 39, Number 11, Page 1259
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, and Richard A. Anderson
Human Reproduction, 2016, Volume 31, Number 5, Page 1126
Priya Bhide and Roy Homburg
Best Practice & Research Clinical Obstetrics & Gynaecology, 2016, Volume 37, Page 38
Kylie Pearson, Matthew Long, Josephine Prasad, Ye Ying Wu, and Michael Bonifacio
Reproductive Biology and Endocrinology, 2016, Volume 14, Number 1
Martine Depmann, Simone L. Broer, Yvonne T. van der Schouw, Fahimeh R. Tehrani, Marinus J. Eijkemans, Ben W. Mol, and Frank J. Broekmans
Menopause, 2016, Volume 23, Number 2, Page 224
Pascal Pigny, Elisse Gorisse, Amjad Ghulam, Geoffroy Robin, Sophie Catteau-Jonard, Alain Duhamel, and Didier Dewailly
Fertility and Sterility, 2016, Volume 105, Number 4, Page 1063
Michael W. Pankhurst and Ian S. McLennan
Molecular and Cellular Endocrinology, 2016, Volume 419, Page 165
E. Anckaert, M. Öktem, A. Thies, M. Cohen-Bacrie, N.M.P. Daan, J. Schiettecatte, C. Müller, D. Topcu, A. Gröning, F. Ternaux, C. Engel, S. Engelmann, and C. Milczynski
Clinical Biochemistry, 2016, Volume 49, Number 3, Page 260
Stamatina Iliodromiti, Richard A. Anderson, and Scott M. Nelson
Human Reproduction Update, 2015, Volume 21, Number 6, Page 698
Josephine Hyldgaard, Pinar Bor, Hans Jakob Ingerslev, and Niels Tørring
Reproductive Biology and Endocrinology, 2015, Volume 13, Number 1
Aaron K. Styer, Audrey J. Gaskins, Paula C. Brady, Patrick M. Sluss, Jorge E. Chavarro, Russ B. Hauser, and Thomas L. Toth
Fertility and Sterility, 2015, Volume 104, Number 5, Page 1153
Josef van Helden and Ralf Weiskirchen
Human Reproduction, 2015, Volume 30, Number 8, Page 1918
Scott M. Nelson, Ewa Pastuszek, Grzegorz Kloss, Iwona Malinowska, Joanna Liss, Aron Lukaszuk, Lukasz Plociennik, and Krzysztof Lukaszuk
Fertility and Sterility, 2015, Volume 104, Number 4, Page 1016
Richard Fleming, David B. Seifer, John L. Frattarelli, and Jane Ruman
Reproductive BioMedicine Online, 2015, Volume 31, Number 4, Page 486
Scott M. Nelson, Richard Fleming, Marco Gaudoin, Bokyung Choi, Kenny Santo-Domingo, and Mylene Yao
Fertility and Sterility, 2015, Volume 104, Number 2, Page 325
Stamatina Iliodromiti and Scott M. Nelson
Current Opinion in Obstetrics and Gynecology, 2015, Volume 27, Number 3, Page 182
Richard A. Anderson, Ellen Anckaert, Ernesto Bosch, Didier Dewailly, Cheryl E. Dunlop, Daniel Fehr, Luciano Nardo, Johan Smitz, Kelton Tremellen, Barbara Denk, Andrea Geistanger, and Martin Hund
Fertility and Sterility, 2015, Volume 103, Number 4, Page 1074
Damien Gruson and Evgenija Homsak
Clinical Biochemistry, 2015, Volume 48, Number 6, Page 453
C. Peluso, F.L.A. Fonseca, I.F. Rodart, V. Cavalcanti, G. Gastaldo, D.M. Christofolini, C.P. Barbosa, and B. Bianco
Clinica Chimica Acta, 2014, Volume 437, Page 175
Scott M. Nelson, Stamatina Iliodromiti, and Richard A. Anderson
Fertility and Sterility, 2014, Volume 102, Number 1, Page e2

Comments (0)

Please log in or register to comment.
Log in