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Development of matrix-based reference materials for 17 beta-estradiol by the recommended reference method of ID-LC-MS/MS

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Abstract

We developed and evaluated two-level, namely 2017011 and 2017012, serum-based reference materials (RMs) for 17 beta-estradiol (17 β-E2) by the reference method of isotope dilution liquid chromatography tandem mass spectrometry (ID-LC-MS/MS) from the remaining serum samples after routine clinical tests, to help improve clinical routine testing and provide the traceability of results. This paper describes the development process of these RMs. The National Metrology Institute of Japan (NMIJ) certified reference material (CRM) 6004-a was used as the primary RM for the measurement of 17 β-E2. These serum-based RMs showed satisfactory homogeneity and stability. They also assessed the commutability between the reference method and the three routine clinical immunoassay systems. Besides, a collaborative study was carried out in five reference laboratories, all of which had been accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in accordance with ISO/WD 15725-1. Statistical analysis of raw results and uncertainty assessment obtained certified values: 2017011 was 445.2 ± 39.0 pmol/L, and 2017012 was 761.9 ± 35.5 pmol/L.

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Data Availability

The data that support the findings of this study are available on request from the corresponding author, QXZ，upon reasonable request.

Change history

  • 29 July 2023

    Springer Nature’s version of this paper was updated. The e-mail addresses of the two corresponding authors were swapped.

Abbreviations

17 β-E2:

17 Beta-estradiol

RM:

Reference material

CRM:

Certified reference material

ID-LC-MS/MS:

Isotope dilution liquid chromatography tandem mass spectrometry

JCTLM:

Joint Committee on Traceability in Laboratory Medicine

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Acknowledgements

We greatly appreciate the following reference laboratories which participated in the collaborative study of value assignment of the RM: Maccura Biotechnology (ISO/IEC 17025 accreditation CNAS: L6172); Shanghai Center for Clinical Laboratory (ISO/IEC 17025 accreditation CNAS: L6730); Autobio Diagnostics Co. Ltd. Zhengzhou Eco&Tech Zone (ISO/IEC 17025 accreditation CNAS: L13885); and Shanghai Kehua Bio-engineering Co., Ltd. (ISO/IEC 17025 accreditation CNAS: L13117).

Funding

This research was supported by the National Key Research and Development Program of China (2022YFF0710300, 2022YFF0710302), the "Young Talents Program" of Guangdong Academy of Traditional Chinese Medicine (SZ2022QN09), the State Key Laboratory of Dampness Syndrome of Chinese Medicine (SZ2021ZZ30, SZ2021ZZ3003), the Natural Science Foundation of Guangdong Province (2021A1515220099), and the Guangzhou Science and Technology Plan Projects (202201011506).

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Author notes

  1. Haibiao Lin and Dan Liu contributed equally to this work.

Authors and Affiliations

  1. Department of Laboratory Medicine, the Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China

    Haibiao Lin, Dan Liu, Li Deng, Jun Yan, Liqiao Han, Min Zhan, Pengwei Zhang, Jianbing Wang, Min He, Qiaoxuan Zhang & Xianzhang Huang

  2. State Key Laboratory of Dampness, Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China

    Haibiao Lin, Dan Liu, Jun Yan, Liqiao Han, Min Zhan, Pengwei Zhang, Jianbing Wang, Min He, Qiaoxuan Zhang & Xianzhang Huang

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  1. Haibiao Lin
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  2. Dan Liu
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  3. Li Deng
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Corresponding authors

Correspondence to Qiaoxuan Zhang or Xianzhang Huang.

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Ethics approval

The research involved plasma samples taken from pregnant women, and this study was approved by the Ethics Committee of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. The number of this study was ZE2019-149-01.

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Lin, H., Liu, D., Deng, L. et al. Development of matrix-based reference materials for 17 beta-estradiol by the recommended reference method of ID-LC-MS/MS. Anal Bioanal Chem 415, 5637–5644 (2023). https://doi.org/10.1007/s00216-023-04832-2

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  • DOI: https://doi.org/10.1007/s00216-023-04832-2

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