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Development of certified reference materials for electrolytes in human serum (GBW09124-09126)

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Abstract

Three reference materials, at relatively low, middle, and high concentrations, were developed for analysis of the mass fractions of electrolytes (K, Ca, Na, Mg, Cl, and Li) in human serum. The reference materials were prepared by adding high purity chloride salts to normal human serum. The concentration range of the three levels is within ±20% of normal human serum. It was shown that 14 units with duplicate analysis is enough to demonstrate the homogeneity of these candidate reference materials. The statistical results also showed no significant trends in both short-term stability test for 1 week at 40 °C and long-term stability test for 14 months. The certification methods of the six elements include isotope dilution inductively coupled plasma mass spectrometry (ID-ICP-MS), inductively coupled plasma optical emission spectroscopy (ICP-OES), atomic absorption spectroscopy (AAS), ion chromatography (IC), and ion-selective electrode (ISE). The certification methods were validated by international comparisons among a number of national metrology institutes (NMIs). The combined relative standard uncertainties of the property values were estimated by considering the uncertainties of the analytical methods, homogeneity, and stability. The range of the expanded uncertainties of all the elements is from 2.2% to 3.9%. The certified reference materials (CRMs) are primarily intended for use in the calibration and validation of procedures in clinical analysis for the determination of electrolytes in human serum or plasma.

Certified reference materials for K, Ca, Mg, Na, Cl and Li in human serum (GBW09124-09126)

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Acknowledgements

The authors gratefully acknowledge the financial support from the National Basic Research Priorities Program (No. 2011FY130100), National Natural Science Foundation (No. 11475163), and NIM Fundamental Research Program (No. AKY1403).

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Authors and Affiliations

  1. Division of Metrology in Chemistry, National Institute of Metrology, Beijing, 100029, China

    Liuxing Feng, Jun Wang, Yanjie Cui, Naijie Shi, Haifeng Li & Hongmei Li

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  1. Liuxing Feng
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  2. Jun Wang
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  3. Yanjie Cui
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  4. Naijie Shi
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  5. Haifeng Li
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  6. Hongmei Li
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Correspondence to Liuxing Feng.

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The authors declare that they have no conflict of interest.

Informed consent was obtained from all individual participants included in the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the Chinese PLA Center for Disease Control & Prevention and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

This article does not contain any studies with animals performed by any of the authors.

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Feng, L., Wang, J., Cui, Y. et al. Development of certified reference materials for electrolytes in human serum (GBW09124-09126). Anal Bioanal Chem 409, 3483–3493 (2017). https://doi.org/10.1007/s00216-017-0287-9

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  • DOI: https://doi.org/10.1007/s00216-017-0287-9

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