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Traceable value of immunoglobulin G against receptor-binding domain of SARS-CoV-2 confirmation and application to point-of-care testing system development

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Abstract

A highly purified and bioactive immunoglobulin G monoclonal antibody against receptor-binding domain of SARS-CoV-2 (RBD-IgG-MAb) has been accurately quantified by amino acid determination using isotope dilution liquid chromatography–mass spectrometry. Absolute quantification of RBD-IgG-MAb was achieved by averaging 4 amino acid certified reference materials, which allows the quantitative value (66.1 ± 5.8 μg/L) to be traced to SI unit (mol). Afterwards, the RBD-IgG-MAb was employed as control and calibration compound for the development of a point-of-care testing (POCT) system based on colloidal gold lateral flow immunoassay, which aimed to rapidly and accurately detect the level of protective RBD-IgG after vaccination. Under the detection parameters, a sigmoidal curve has been plotted between signal intensity and the logarithmic concentration for quantitative detection with the limit of detection of about 0.39 μg/mL. The relative standard deviations of intra-assay and inter-assay were lower than 2.3% and 14%, and the recoveries ranged from 87 to 100%, respectively. Fingertip blood samples from 37 volunteers after vaccination were analyzed by the POCT system; results showed that levels of RBD-IgG in 33 out of 37 samples ranged from 0.45 to 2.46 μg/mL with the average level of 0.91 μg/mL. The developed POCT system has been successfully established with the quantity-traceability RBD-IgG-MAb as control and calibration compound, and the scientific contribution of this work can be promoted to other areas.

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Data Availability

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

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Acknowledgements

We thank Suzhou Novoprotein Technology Co. Ltd. for their provision of RBD-IgG-MAb raw materials. And the authors appreciate the support of colleagues in the Center for Advanced Measurement of Science, NIM.

Funding

This work was financially supported by the National Key Research and Development program of China (No. 2022YFF0608402) and Fundamental Research Funds for Central Public Welfare Scientific Research Institutes sponsored by National Institute of Metrology, P.R. China (No. AKYYJ2111-2).

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Author notes

  1. Zhanwei Liang and Xin Lu contributed equally to this work.

Authors and Affiliations

  1. Technology Innovation Center of Mass Spectrometry for State Market Regulation, Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, People’s Republic of China

    Zhanwei Liang, Xin Lu, Xueshima Jiao, Bo Meng, Jie Xie, Ziyu Qu, Manman Zhu, Xiaoyun Gong, Yang Zhao, Tao Peng, Xiang Fang & Xinhua Dai

  2. Novoprotein Scientific Incorporation, Suzhou, 215200, People’s Republic of China

    Yi He

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Contributions

Zhanwei Liang and Xin Lu: investigation, validation, visualization, data curation, writing — original draft preparation. Xueshima Jiao: investigation, validation, data curation. Yi He: validation, formal analysis. Bo Meng: investigation, data curation. Jie Xie: validation, formal analysis. Ziyu Qu: resources. Manman Zhu: validation, resources. Xiaoyun Gong: resources, formal analysis. Yang Zhao: formal analysis. You Jiang: resources, formal analysis. Tao Peng: methodology, formal analysis, data curation, writing — original draft preparation, writing — reviewing and editing, funding acquisition. Xinhua Dai: methodology, supervision, writing — reviewing and editing. Xiang Fang: project administration, supervision, conceptualization.

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Correspondence to Tao Peng, Xiang Fang or Xinhua Dai.

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Liang, Z., Lu, X., Jiao, X. et al. Traceable value of immunoglobulin G against receptor-binding domain of SARS-CoV-2 confirmation and application to point-of-care testing system development. Microchim Acta 190, 417 (2023). https://doi.org/10.1007/s00604-023-06004-6

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