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Development of anti-Müllerian hormone immunoassay based on biolayer interferometry technology

  • Yu Wang
  • Emmanuel Enoch Dzakah
  • Ye Kang
  • Yanxue Cai
  • Peidian Wu
  • Yue Cui
  • Youzhen Huang
  • Xiaowei HeEmail author
Research Paper

Abstract

Anti-Müllerian hormone (AMH) is a biomarker for the assessment of female fertility. The accurate measurement of the concentration of AMH is relevant for the success of assisted reproductive therapies and diagnosis of clinical cases. In this study, we show that cytokines such as fetal liver tyrosine kinase 3 ligand (Flt3L), CC subtype chemokine ligand 20 (CCL20), granulocyte–macrophage colony-stimulating factor (GM-CSF), and β2-microglobulin (β2M) significantly enhance the immune response against AMH. Two anti-AMH monoclonal antibodies (mAbs) with high affinity were selected by biolayer interferometry (BLI) technology for application in a fully automated magnetic chemiluminescence immunoassay (CLIA). This robust and rapid assay can efficiently detect AMH in the range of 0.125~20 ng mL−1 with a detection limit of 0.099 ng mL−1. This immunoassay showed high specificity with no cross-reaction with structurally related proteins and some of the other members of the TGF-β super family, such as inhibin A, activin A, follicle-stimulating hormone, and luteinizing hormone. The average recovery rates of three different batches were 100.19%, 102.72%, and 103.59%, respectively, with coefficients of variation of less than 12%. The developed assay was applied in the detection of AMH in 69 serum samples from randomly selected patients. Our data showed a high correlation with those obtained using commercially available ELISA kits (correlation coefficient, 0.9831). Hence, we suggest that this immunoassay could find application in the development of POCT for the diagnosis of AMH in clinical samples.

Graphical abstract

Keywords

Anti-Müllerian hormone Cytokine DNA immunization High-affinity antibodies Point-of-care testing 

Notes

Funding information

This work is supported by the Program of Guangzhou Science & Technology (201802010030).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All animal experiments and welfare of the animals were performed under ethical approval from and in agreement with the guidelines of the Institutional Animal Care and Use Ethics Committee of South China University of Technology and also in accordance with the policy of the National Ministry of Health. Written informed consents were obtained from all individual participants who provided the serum samples.

Supplementary material

216_2019_1928_MOESM1_ESM.pdf (689 kb)
ESM 1 (PDF 689 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Yu Wang
    • 1
  • Emmanuel Enoch Dzakah
    • 2
    • 3
  • Ye Kang
    • 1
  • Yanxue Cai
    • 4
  • Peidian Wu
    • 5
  • Yue Cui
    • 5
  • Youzhen Huang
    • 5
  • Xiaowei He
    • 1
    Email author
  1. 1.College of Food Science and EngineeringSouth China University of TechnologyGuangzhouChina
  2. 2.Department of Molecular Biology and Biotechnology, School of Biological Sciences, College of Agriculture and Natural SciencesUniversity of Cape CoastCape CoastGhana
  3. 3.Guangdong Provincial Dermatology HospitalSouthern Medical UniversityGuangzhouChina
  4. 4.School of Chemical Engineering and Energy TechnologyDongguan University of TechnologyDongguanChina
  5. 5.National & Local United Engineering Lab of Rapid Diagnostic TestGuangzhou Wondfo Biotech Co., Ltd.GuangzhouChina

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