PMID- 38427100
OWN - NLM
STAT- MEDLINE
DCOM- 20240329
LR  - 20240329
IS  - 1618-2650 (Electronic)
IS  - 1618-2642 (Linking)
VI  - 416
IP  - 10
DP  - 2024 Apr
TI  - Quantification of SARS-CoV-2 monoclonal IgG mass fraction by isotope dilution 
      mass spectrometry.
PG  - 2423-2437
LID - 10.1007/s00216-024-05205-z [doi]
AB  - The availability of serology assays to measure antibodies against the SARS 
      coronavirus 2 (SARS-CoV-2) expanded rapidly during the Covid-19 pandemic. The 
      interchangeable use of such assays to monitor disease progression and immune 
      protection requires their standardization, for which suitably characterized 
      monoclonal antibody materials can be useful. The methods, based on isotope 
      dilution mass spectrometry, to value assign the mass fraction of such a material 
      in solution within the context of an international interlaboratory comparison 
      study (CCQM-P216) are described. The mass fraction in solution of a humanized IgG 
      monoclonal antibody (mAb) against the SARS-CoV-2 Spike glycoprotein in the study 
      sample has been value assigned through a combination of liquid chromatography, 
      isotope dilution mass spectrometry (LC-ID-MS) methods and size exclusion 
      chromatography with UV detection (SEC-UV). The former were developed for the 
      quantification of amino acids and proteotypic peptides as surrogate analytes of 
      the mAb while the latter was applied for the determination of the relative 
      monomeric mass fraction. High-resolution mass spectrometry (hrMS) allowed the 
      molecular weight evaluation and ruled out the presence of significant impurities. 
      Method trueness was assessed using a subclass homologous IgG1 material value 
      assigned by amino acid analysis. The assigned mass fraction of monomeric 
      SARS-CoV-2 IgG in solution was 390 +/- 16 mg/g. The associated expanded uncertainty 
      originated mainly from acid hydrolysis variability and Trypsin/Lys-C digestion 
      variability and efficiency.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part 
      of Springer Nature.
FAU - Martos, G
AU  - Martos G
AUID- ORCID: 0000-0001-6434-1769
AD  - Bureau International Des Poids Et Mesures (BIPM), Sevres, France. 
      Gustavo.martos@bipm.org.
FAU - Bedu, M
AU  - Bedu M
AD  - Bureau International Des Poids Et Mesures (BIPM), Sevres, France.
FAU - Josephs, R D
AU  - Josephs RD
AD  - Bureau International Des Poids Et Mesures (BIPM), Sevres, France.
FAU - Westwood, S
AU  - Westwood S
AD  - Bureau International Des Poids Et Mesures (BIPM), Sevres, France.
FAU - Wielgosz, R I
AU  - Wielgosz RI
AD  - Bureau International Des Poids Et Mesures (BIPM), Sevres, France.
LA  - eng
PT  - Journal Article
DEP - 20240301
PL  - Germany
TA  - Anal Bioanal Chem
JT  - Analytical and bioanalytical chemistry
JID - 101134327
RN  - 0 (Amino Acids)
RN  - 0 (Isotopes)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Humans
MH  - *SARS-CoV-2
MH  - *COVID-19
MH  - Pandemics
MH  - Mass Spectrometry/methods
MH  - Amino Acids/analysis
MH  - Isotopes
MH  - Antibodies, Monoclonal
MH  - Immunoglobulin G
OTO - NOTNLM
OT  - Amino acid analysis
OT  - Isotope dilution mass spectrometry
OT  - Measurement uncertainty
OT  - Monoclonal antibody
OT  - Reference material
OT  - SARS-CoV-2 antibodies
EDAT- 2024/03/01 12:42
MHDA- 2024/03/29 06:46
CRDT- 2024/03/01 11:07
PHST- 2023/12/21 00:00 [received]
PHST- 2024/02/12 00:00 [accepted]
PHST- 2024/02/08 00:00 [revised]
PHST- 2024/03/29 06:46 [medline]
PHST- 2024/03/01 12:42 [pubmed]
PHST- 2024/03/01 11:07 [entrez]
AID - 10.1007/s00216-024-05205-z [pii]
AID - 10.1007/s00216-024-05205-z [doi]
PST - ppublish
SO  - Anal Bioanal Chem. 2024 Apr;416(10):2423-2437. doi: 10.1007/s00216-024-05205-z. 
      Epub 2024 Mar 1.