Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.
Identifieur interne : 000467 ( Main/Corpus ); précédent : 000466; suivant : 000468Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.
Auteurs : Igor Y. Pavlov ; Rebecca L. Parker ; Eszter Lázár-Molnár ; Frederick G. Strathmann ; Julio C. DelgadoSource :
- Journal of immunological methods [ 1872-7905 ] ; 2019.
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
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pubmed:31034880Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.</title><author><name sortKey="Pavlov, Igor Y" sort="Pavlov, Igor Y" uniqKey="Pavlov I" first="Igor Y" last="Pavlov">Igor Y. Pavlov</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Parker, Rebecca L" sort="Parker, Rebecca L" uniqKey="Parker R" first="Rebecca L" last="Parker">Rebecca L. Parker</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Lazar Molnar, Eszter" sort="Lazar Molnar, Eszter" uniqKey="Lazar Molnar E" first="Eszter" last="Lázár-Molnár">Eszter Lázár-Molnár</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Strathmann, Frederick G" sort="Strathmann, Frederick G" uniqKey="Strathmann F" first="Frederick G" last="Strathmann">Frederick G. Strathmann</name><affiliation><nlm:affiliation>NMS Laboratories, Willow Grove, PA, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Delgado, Julio C" sort="Delgado, Julio C" uniqKey="Delgado J" first="Julio C" last="Delgado">Julio C. Delgado</name><affiliation><nlm: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.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:31034880</idno><idno type="pmid">31034880</idno><idno type="doi">10.1016/j.jim.2019.04.008</idno><idno type="wicri:Area/Main/Corpus">000467</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000467</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.</title><author><name sortKey="Pavlov, Igor Y" sort="Pavlov, Igor Y" uniqKey="Pavlov I" first="Igor Y" last="Pavlov">Igor Y. Pavlov</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Parker, Rebecca L" sort="Parker, Rebecca L" uniqKey="Parker R" first="Rebecca L" last="Parker">Rebecca L. Parker</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Lazar Molnar, Eszter" sort="Lazar Molnar, Eszter" uniqKey="Lazar Molnar E" first="Eszter" last="Lázár-Molnár">Eszter Lázár-Molnár</name><affiliation><nlm:affiliation>ARUP Laboratories, Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Strathmann, Frederick G" sort="Strathmann, Frederick G" uniqKey="Strathmann F" first="Frederick G" last="Strathmann">Frederick G. Strathmann</name><affiliation><nlm:affiliation>NMS Laboratories, Willow Grove, PA, United States of America.</nlm:affiliation></affiliation></author><author><name sortKey="Delgado, Julio C" sort="Delgado, Julio C" uniqKey="Delgado J" first="Julio C" last="Delgado">Julio C. Delgado</name><affiliation><nlm: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.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of immunological methods</title><idno type="eISSN">1872-7905</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Infliximab</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Immunoglobulin G</term><term>Lanthanoid Series Elements</term><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Crohn Disease</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Crohn Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Crohn Disease</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Monitoring</term><term>Spectrophotometry, Atomic</term><term>Staining and Labeling</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Drug Monitoring</term><term>Spectrophotometry, Atomic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Female</term><term>Humans</term><term>Limit of Detection</term><term>Male</term><term>Middle Aged</term><term>Observer Variation</term><term>Reproducibility of Results</term></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">31034880</PMID><DateCompleted><Year>2020</Year><Month>05</Month><Day>06</Day></DateCompleted><DateRevised><Year>2020</Year><Month>05</Month><Day>06</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1872-7905</ISSN><JournalIssue CitedMedium="Internet"><Volume>470</Volume><PubDate><Year>2019</Year><Month>07</Month></PubDate></JournalIssue><Title>Journal of immunological methods</Title><ISOAbbreviation>J Immunol Methods</ISOAbbreviation></Journal><ArticleTitle>Inductively coupled plasma mass spectrometry assay for quantification of free infliximab in serum.</ArticleTitle><Pagination><MedlinePgn>33-39</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0022-1759(19)30027-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jim.2019.04.008</ELocationID><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></AffiliationInfo></Author><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></Author><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></Author><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></Author><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></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D023361">Validation Study</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>04</Month><Day>26</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>J Immunol Methods</MedlineTA><NlmUniqueID>1305440</NlmUniqueID><ISSNLinking>0022-1759</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007074">Immunoglobulin G</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D028581">Lanthanoid Series Elements</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014409">Tumor Necrosis Factor-alpha</NameOfSubstance></Chemical><Chemical><RegistryNumber>B72HH48FLU</RegistryNumber><NameOfSubstance UI="D000069285">Infliximab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003424" MajorTopicYN="N">Crohn Disease</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016903" MajorTopicYN="N">Drug Monitoring</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007074" MajorTopicYN="N">Immunoglobulin G</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069285" MajorTopicYN="N">Infliximab</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D028581" MajorTopicYN="N">Lanthanoid Series Elements</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057230" MajorTopicYN="N">Limit of Detection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015588" MajorTopicYN="N">Observer Variation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013054" MajorTopicYN="N">Spectrophotometry, Atomic</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013194" MajorTopicYN="N">Staining and Labeling</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014409" MajorTopicYN="N">Tumor Necrosis Factor-alpha</DescriptorName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Autoimmunity</Keyword><Keyword MajorTopicYN="Y">Drug monitoring</Keyword><Keyword MajorTopicYN="Y">Inductively coupled plasma mass spectrometry</Keyword><Keyword MajorTopicYN="Y">Infliximab</Keyword><Keyword MajorTopicYN="Y">TNF antagonists</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>01</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2019</Year><Month>04</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>04</Month><Day>25</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2019</Year><Month>4</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>5</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>4</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">31034880</ArticleId><ArticleId IdType="pii">S0022-1759(19)30027-4</ArticleId><ArticleId IdType="doi">10.1016/j.jim.2019.04.008</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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