Development of a human insulin certified reference material with SI-traceable purity

Wang, Xianxia; Wu, Liqing; Huang, Yanjie; Su, Ping; Yang, Yi; Yang, Bin; Zhang, Ning

doi:10.1007/s00216-022-03965-0

Cited by 5 publications

(6 citation statements)

References 36 publications

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“…Symbols w x denote the mass fraction of X in the solution ( X = A, A*, or B), m x ( xy ) is the mass of solution x to prepare the blend xy , and r x is the measured isotope amount ratio of x . Validation of this technique has been demonstrated in interlaboratory comparisons − and has facilitated the development of multiple protein reference materials. ,, …”

Section: Methodsmentioning

confidence: 99%

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

et al. 2022

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Rapid antigen tests have become a widely used COVID-19 diagnostic tool with demand accelerating in response to the highly contagious SARS-CoV-2 Omicron variant. Hundreds of such test kits are approved for use worldwide, predominantly reporting on the presence of the viral nucleocapsid (N) protein, yet the comparability among manufacturers remains unclear and the need for reference standards is recognized. To address this lack of standardization, the National Research Council Canada has developed a SARS-CoV-2 nucleocapsid protein reference material solution, NCAP-1. Reference value determination for N protein content was realized by amino acid analysis (AAA) via double isotope dilution liquid chromatography−tandem mass spectrometry (LC-ID-MS/MS) following acid hydrolysis of the protein, in conjunction with UV spectrophotometry based on tryptophan and tyrosine absorbance at 280 nm. The homogeneity of the material was established through spectrophotometric absorbance readings at 280 nm. The molar concentration of the N protein in NCAP-1 was 10.0 ± 1.9 μmol L −1 (k = 2, 95% confidence interval). Reference mass concentration and mass fraction values were subsequently calculated using the protein molecular weight and density of the NCAP-1 solution. Changes to protein higher-order structure, probed by size-exclusion liquid chromatography (LC-SEC) with UV detection, were used to evaluate transportation and storage stabilities. LC-SEC revealed nearly 90% of the N protein in the material is present as a mixture of hexamers and tetramers. The remaining low molecular weight species (<30 kDa) were interrogated by top-down mass spectrometry and determined to be autolysis products homologous to those previously documented for N protein of the original SARS-CoV [Biochem.

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Section: Methodsmentioning

confidence: 99%

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

et al. 2022

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“…Pooled human serum was obtained from Innovative Research (Canada) followed by homogenization, filtration, and aliquots in‐house protocol (Supporting Information). Human insulin certified reference materials (CRMs) were purchased from the National Metrology Institute of Japan (NMIJ CRM 6209‐a) and Cerilliant Corporation (I‐034) 18 . Both serum and CRMs were stored at −70°C prior to use.…”

Section: Methodsmentioning

confidence: 99%

“…Human insulin certified reference materials (CRMs) were purchased from the National Metrology Institute of Japan (NMIJ CRM 6209-a) and Cerilliant Corporation (I-034). 18 Both serum and CRMs were stored at −70°C prior to use. Bovine serum albumin (BSA), HPLC-grade acetonitrile, formic acid, and trifluoroacetic acid were obtained from Sigma-Aldrich.…”

Section: Chemicalsmentioning

confidence: 99%

Measurement comparability of insulin assays using conventional immunoassay kits

Rosli

Kwon

Lim

et al. 2022

Clinical Laboratory Analysis

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Immunoassays are analytical methods that achieve the detection and quantification of analytes, particularly peptides and proteins in biological samples, through the formation of a stable complex between the analyte and a specific antibody. They represent very selective and sensitive techniques that have found application in several areas such as clinical chemistry, bioanalysis, pharmaceutical analysis, toxicological analysis, and environmental analysis. [1][2][3] Owing to their capacity for high throughput and significantly reduced average analytical times, through the simultaneous analysis of numerous samples with ultimate detection sensitivity, immunoassays are the preferred platform for most protein studies, particularly clinical diagnostics and drug development where specificity is critical. 4-6 Among various immunoassays, the most commonly employed in routine clinical settings are the enzyme-linked immunosorbent assay (ELISA)

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“…Therefore, the accurate assessment of the purity of peptides and proteins is a necessity. 19 Common approaches to such analyses include mass balance, 20,21 isotope dilution mass spectrometry (IDMS) [19][20][21][22][23][24][25][26] and quantitative nuclear magnetic resonance. 19,[26][27][28] However, mass balance is only suitable for evaluating the purity of solid peptides and proteins while quantitative nuclear magnetic resonance can only be employed in the evaluation of peptides with molecular weights of less than 10 000 Da.…”

Section: Introductionmentioning

confidence: 99%

“…19,[26][27][28] However, mass balance is only suitable for evaluating the purity of solid peptides and proteins while quantitative nuclear magnetic resonance can only be employed in the evaluation of peptides with molecular weights of less than 10 000 Da. 26,27 Hence, IDMS [19][20][21][22][23][24][25][26] is oen employed to ascertain the purity of these compounds. In this technique, peptides or proteins undergo hydrolysis to yield their individual amino acids.…”

Section: Introductionmentioning

confidence: 99%

Determination of [Glu¹]-fibrinopeptide B purity by gas chromatography – isotope dilution mass spectrometry

Zhou,

Wang,

Zou

et al. 2024

Anal. Methods

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Development of a human insulin certified reference material with SI-traceable purity

Cited by 5 publications

References 36 publications

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

Measurement comparability of insulin assays using conventional immunoassay kits

Determination of [Glu¹]-fibrinopeptide B purity by gas chromatography – isotope dilution mass spectrometry

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Development of a human insulin certified reference material with SI-traceable purity

Cited by 5 publications

References 36 publications

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material

Measurement comparability of insulin assays using conventional immunoassay kits

Determination of [Glu1]-fibrinopeptide B purity by gas chromatography – isotope dilution mass spectrometry

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Determination of [Glu¹]-fibrinopeptide B purity by gas chromatography – isotope dilution mass spectrometry