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<p>The persistent evolution of SARS-CoV-2 and its sustained global public health impacts necessitate enhanced diagnostic precision and efficiency. Although certified reference materials (CRMs) are fundamental for ensuring methodological reliability and cross-platform consistency, CRMs with metrological traceability specifically targeting the SARS-CoV-2 spike protein receptor-binding domain (S-RBD) remain unavailable. To bridge this gap, two isotope dilution mass spectrometry (IDMS)–based quantification methods were developed for S-RBD protein analysis at the amino acid and peptide levels. These methods enabled systematic characterization of the reference material’s homogeneity, stability, and measurement uncertainty. The final CRM demonstrates a certified S-RBD protein concentration of 90.4 ± 8.5&#xa0;µg/g (<i>k</i> = 2), with metrological traceability to the International System of Units (SI), thereby establishing a technical framework for standardizing S-RBD detection assays and quality control in biomedical product development.</p> Graphical abstract <p></p>

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Development and certification of SARS-CoV-2 S-RBD protein reference material via dual isotope dilution mass spectrometry

  • 期刊论文

  • 发表日期：

    2026年3月13日

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  • Ruiqi Wang,
  • Yunfang Liu,
  • Liqing Wu,
  • Yahui Liu

摘要

The persistent evolution of SARS-CoV-2 and its sustained global public health impacts necessitate enhanced diagnostic precision and efficiency. Although certified reference materials (CRMs) are fundamental for ensuring methodological reliability and cross-platform consistency, CRMs with metrological traceability specifically targeting the SARS-CoV-2 spike protein receptor-binding domain (S-RBD) remain unavailable. To bridge this gap, two isotope dilution mass spectrometry (IDMS)–based quantification methods were developed for S-RBD protein analysis at the amino acid and peptide levels. These methods enabled systematic characterization of the reference material’s homogeneity, stability, and measurement uncertainty. The final CRM demonstrates a certified S-RBD protein concentration of 90.4 ± 8.5 µg/g (k = 2), with metrological traceability to the International System of Units (SI), thereby establishing a technical framework for standardizing S-RBD detection assays and quality control in biomedical product development.

Graphical abstract