Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.
Identifieur interne : 000462 ( Main/Exploration ); précédent : 000461; suivant : 000463Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.
Auteurs : Igor Y. Pavlov [États-Unis] ; Rebecca L. Parker [États-Unis] ; Eszter Lázár-Molnár [États-Unis] ; Frederick G. Strathmann [États-Unis] ; Julio C. Delgado [États-Unis]Source :
- Journal of immunological methods [ 1872-7905 ] ; 2019.
Descripteurs français
- KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Anticorps monoclonaux (composition chimique), Biais de l'observateur (MeSH), Coloration et marquage (méthodes), Facteur de nécrose tumorale alpha (composition chimique), Facteur de nécrose tumorale alpha (immunologie), Femelle (MeSH), Humains (MeSH), Immunoglobuline G (composition chimique), Infliximab (sang), Lanthanides (composition chimique), Limite de détection (MeSH), Maladie de Crohn (diagnostic), Maladie de Crohn (sang), Maladie de Crohn (traitement médicamenteux), Mâle (MeSH), Reproductibilité des résultats (MeSH), Spectrophotométrie atomique (méthodes), Spectrophotométrie atomique (normes), Sujet âgé (MeSH), Surveillance des médicaments (méthodes), Surveillance des médicaments (normes).
- MESH :
- composition chimique : Anticorps monoclonaux, Facteur de nécrose tumorale alpha, Immunoglobuline G, Lanthanides.
- diagnostic : Maladie de Crohn.
- immunologie : Facteur de nécrose tumorale alpha.
- méthodes : Coloration et marquage, Spectrophotométrie atomique, Surveillance des médicaments.
- normes : Spectrophotométrie atomique, Surveillance des médicaments.
- sang : Infliximab, Maladie de Crohn.
- traitement médicamenteux : Maladie de Crohn.
- Adolescent, Adulte, Adulte d'âge moyen, Biais de l'observateur, Femelle, Humains, Limite de détection, Mâle, Reproductibilité des résultats, Sujet âgé.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Antibodies, Monoclonal (chemistry), Crohn Disease (blood), Crohn Disease (diagnosis), Crohn Disease (drug therapy), Drug Monitoring (methods), Drug Monitoring (standards), Female (MeSH), Humans (MeSH), Immunoglobulin G (chemistry), Infliximab (blood), Lanthanoid Series Elements (chemistry), Limit of Detection (MeSH), Male (MeSH), Middle Aged (MeSH), Observer Variation (MeSH), Reproducibility of Results (MeSH), Spectrophotometry, Atomic (methods), Spectrophotometry, Atomic (standards), Staining and Labeling (methods), Tumor Necrosis Factor-alpha (chemistry), Tumor Necrosis Factor-alpha (immunology).
- MESH :
- chemical , blood : Infliximab.
- chemical , chemistry : Antibodies, Monoclonal, Immunoglobulin G, Lanthanoid Series Elements, Tumor Necrosis Factor-alpha.
- blood : Crohn Disease.
- diagnosis : Crohn Disease.
- drug therapy : Crohn Disease.
- chemical , immunology : Tumor Necrosis Factor-alpha.
- methods : Drug Monitoring, Spectrophotometry, Atomic, Staining and Labeling.
- standards : Drug Monitoring, Spectrophotometry, Atomic.
- Adolescent, Adult, Aged, Female, Humans, Limit of Detection, Male, Middle Aged, Observer Variation, Reproducibility of Results.
Abstract
TNF antagonists such as infliximab are effective for the treatment of several inflammatory and autoimmune diseases. Recent clinical studies have advocated the importance of measuring trough infliximab levels to guide treatment decisions. We have developed a novel assay for measuring serum free infliximab levels using inductively coupled plasma-mass spectrometry (ICP-MS). The method involves the incubation of patient serum in wells coated with recombinant TNF, followed by detection with lanthanide-labeled monoclonal anti-human IgG1 and ICP-MS analysis. Full method validation was performed and results for clinical samples tested with the new method were compared with those obtained from a capture ELISA and a cell-based assay. Validation of the ICP-MS assay revealed a lower limit of detection of 0.4 μg/mL in serum. The linear range of quantitation was 1-50 μg/mL. The within-run and between-run precision had a coefficient of variation (CV) of <10%, and the accuracy of the assay had a CV of <15%. In serum samples, the ICP-MS method was devoid of analytical interferences by high levels of hemoglobin, bilirubin and triglycerides. Serum sample results from 123 drug-naïve donors revealed a test cutoff at 0.5 μg/mL. Test results from clinical samples obtained by the ICP-MS method showed strong correlation with both the ELISA and cell-based assay. The ICP-MS methodology presented in this study is a robust method for measuring TNF antagonist serum levels, which makes it well suited for therapeutic drug monitoring in the clinical laboratory.
DOI: 10.1016/j.jim.2019.04.008
PubMed: 31034880
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<term>Aged (MeSH)</term>
<term>Antibodies, Monoclonal (chemistry)</term>
<term>Crohn Disease (blood)</term>
<term>Crohn Disease (diagnosis)</term>
<term>Crohn Disease (drug therapy)</term>
<term>Drug Monitoring (methods)</term>
<term>Drug Monitoring (standards)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Immunoglobulin G (chemistry)</term>
<term>Infliximab (blood)</term>
<term>Lanthanoid Series Elements (chemistry)</term>
<term>Limit of Detection (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Observer Variation (MeSH)</term>
<term>Reproducibility of Results (MeSH)</term>
<term>Spectrophotometry, Atomic (methods)</term>
<term>Spectrophotometry, Atomic (standards)</term>
<term>Staining and Labeling (methods)</term>
<term>Tumor Necrosis Factor-alpha (chemistry)</term>
<term>Tumor Necrosis Factor-alpha (immunology)</term>
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<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Anticorps monoclonaux (composition chimique)</term>
<term>Biais de l'observateur (MeSH)</term>
<term>Coloration et marquage (méthodes)</term>
<term>Facteur de nécrose tumorale alpha (composition chimique)</term>
<term>Facteur de nécrose tumorale alpha (immunologie)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Immunoglobuline G (composition chimique)</term>
<term>Infliximab (sang)</term>
<term>Lanthanides (composition chimique)</term>
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<term>Maladie de Crohn (traitement médicamenteux)</term>
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<term>Spectrophotométrie atomique (normes)</term>
<term>Sujet âgé (MeSH)</term>
<term>Surveillance des médicaments (méthodes)</term>
<term>Surveillance des médicaments (normes)</term>
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<term>Staining and Labeling</term>
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<term>Maladie de Crohn</term>
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<term>Femelle</term>
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<front><div type="abstract" xml:lang="en">TNF antagonists such as infliximab are effective for the treatment of several inflammatory and autoimmune diseases. Recent clinical studies have advocated the importance of measuring trough infliximab levels to guide treatment decisions. We have developed a novel assay for measuring serum free infliximab levels using inductively coupled plasma-mass spectrometry (ICP-MS). The method involves the incubation of patient serum in wells coated with recombinant TNF, followed by detection with lanthanide-labeled monoclonal anti-human IgG1 and ICP-MS analysis. Full method validation was performed and results for clinical samples tested with the new method were compared with those obtained from a capture ELISA and a cell-based assay. Validation of the ICP-MS assay revealed a lower limit of detection of 0.4 μg/mL in serum. The linear range of quantitation was 1-50 μg/mL. The within-run and between-run precision had a coefficient of variation (CV) of <10%, and the accuracy of the assay had a CV of <15%. In serum samples, the ICP-MS method was devoid of analytical interferences by high levels of hemoglobin, bilirubin and triglycerides. Serum sample results from 123 drug-naïve donors revealed a test cutoff at 0.5 μg/mL. Test results from clinical samples obtained by the ICP-MS method showed strong correlation with both the ELISA and cell-based assay. The ICP-MS methodology presented in this study is a robust method for measuring TNF antagonist serum levels, which makes it well suited for therapeutic drug monitoring in the clinical laboratory.</div>
</front>
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<DateCompleted><Year>2020</Year>
<Month>05</Month>
<Day>06</Day>
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<DateRevised><Year>2020</Year>
<Month>05</Month>
<Day>06</Day>
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<PubDate><Year>2019</Year>
<Month>07</Month>
</PubDate>
</JournalIssue>
<Title>Journal of immunological methods</Title>
<ISOAbbreviation>J Immunol Methods</ISOAbbreviation>
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<ArticleTitle>Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.</ArticleTitle>
<Pagination><MedlinePgn>33-39</MedlinePgn>
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<Abstract><AbstractText>TNF antagonists such as infliximab are effective for the treatment of several inflammatory and autoimmune diseases. Recent clinical studies have advocated the importance of measuring trough infliximab levels to guide treatment decisions. We have developed a novel assay for measuring serum free infliximab levels using inductively coupled plasma-mass spectrometry (ICP-MS). The method involves the incubation of patient serum in wells coated with recombinant TNF, followed by detection with lanthanide-labeled monoclonal anti-human IgG1 and ICP-MS analysis. Full method validation was performed and results for clinical samples tested with the new method were compared with those obtained from a capture ELISA and a cell-based assay. Validation of the ICP-MS assay revealed a lower limit of detection of 0.4 μg/mL in serum. The linear range of quantitation was 1-50 μg/mL. The within-run and between-run precision had a coefficient of variation (CV) of <10%, and the accuracy of the assay had a CV of <15%. In serum samples, the ICP-MS method was devoid of analytical interferences by high levels of hemoglobin, bilirubin and triglycerides. Serum sample results from 123 drug-naïve donors revealed a test cutoff at 0.5 μg/mL. Test results from clinical samples obtained by the ICP-MS method showed strong correlation with both the ELISA and cell-based assay. The ICP-MS methodology presented in this study is a robust method for measuring TNF antagonist serum levels, which makes it well suited for therapeutic drug monitoring in the clinical laboratory.</AbstractText>
<CopyrightInformation>Copyright © 2019 Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pavlov</LastName>
<ForeName>Igor Y</ForeName>
<Initials>IY</Initials>
<AffiliationInfo><Affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</Affiliation>
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<Author ValidYN="Y"><LastName>Parker</LastName>
<ForeName>Rebecca L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo><Affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Lázár-Molnár</LastName>
<ForeName>Eszter</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Strathmann</LastName>
<ForeName>Frederick G</ForeName>
<Initials>FG</Initials>
<AffiliationInfo><Affiliation>NMS Laboratories, Willow Grove, PA, United States of America.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Delgado</LastName>
<ForeName>Julio C</ForeName>
<Initials>JC</Initials>
<AffiliationInfo><Affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America. Electronic address: julio.delgado@path.utah.edu.</Affiliation>
</AffiliationInfo>
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<Month>04</Month>
<Day>26</Day>
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<MedlineTA>J Immunol Methods</MedlineTA>
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<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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