Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?
Infliximab (IFX) is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha. It is currently approved for the treatment of certain rheumatic diseases or inflammatory bowel diseases. Clinical studies have suggested that monitoring IFX concentrations could improve treatment response. Howe...
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| Veröffentlicht in: | Analytical and bioanalytical chemistry 2017-02, Vol.409 (5), p.1195-1205 |
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| description | Infliximab (IFX) is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha. It is currently approved for the treatment of certain rheumatic diseases or inflammatory bowel diseases. Clinical studies have suggested that monitoring IFX concentrations could improve treatment response. However, in most studies, IFX was quantified using ELISA assays, the resulting discrepancies of which raised concerns about their reliability. Here, we describe the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for IFX quantification in human plasma. Full-length stable-isotope-labeled antibody (SIL-IFX) was added to plasma samples as internal standard. Samples were then prepared using Mass Spectrometry Immuno Assay (MSIA™) followed by trypsin digestion and submitted to multiple reaction monitoring (MRM) for quantification of IFX. The chromatographic run lasted 13 min. The range of quantification was 1 to 26 mg/L. For two internal quality controls spiked with 6 and 12 mg/L of IFX, the method was reproducible (coefficients of variation (CV%): 12.7 and 2.1), repeatable (intra-day CV%: 5.5 and 5.0), and accurate (inter-day and intra-day deviations from nominal values: +6.4 to +3.7 % and 5.5 to 9.2 %, respectively). There was no cross - contamination effect. Samples from 45 patients treated with IFX were retrospectively analyzed by LC-MS/MS and results were compared to those obtained with an in-house ELISA assay and the commercial Lisa Tracker® method. Good agreement was found between LC-MS/MS and in-house ELISA (mean underestimation of 13 % for in-house ELISA), but a significant bias was found with commercial ELISA (mean underestimation of 136 % for commercial ELISA). This method will make it possible to standardize IFX quantification between laboratories.
Graphical Abstract
Interassay comparison of the three methods: LC-MS/MS vs inhouse ELISA assay or vs Lisa Tracker® ELISA assays, Passing & Bablok (
a
) and Bland & Altman (
b
) for the comparison of LC-MS/MS vs in-house ELISA assay; Passing & Bablok (
c
); Bland & Altman (
d
) for the comparison LC-MS/MS vs Lisa Tracker® ELISA assay |
| doi_str_mv | 10.1007/s00216-016-0045-4 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_02454688v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A550917129</galeid><sourcerecordid>A550917129</sourcerecordid><originalsourceid>FETCH-LOGICAL-c642t-f309afd3b5d0c5176ed56159686ac3c221d9079c8020e67a221bfb6d9a62aaa83</originalsourceid><addsrcrecordid>eNqNks-L1TAQx4so7rr6B3iRgBc9dJ2kTdp6kcei7sKCFz2HaZq-ZmmT95J09Xn2Dzel6_MHChKGDDOf-TKTTJY9pXBOAapXAYBRkcNiUPK8vJedUkHrnAkO949-yU6yRyHcAFBeU_EwO2FVzYQo4DT7dmX70XwxE7ZkP6ONJmI0zhJjyTBPaMluxDAhaQ9kNPvZdEQN3k0Y3dbjbjjkEW2nJzJhCCTstIopq6M_vCbRfUbfBYIkLFDyzddV3PUkDpokbnBdePM4e9DjGPSTu_ss-_Tu7ceLy_z6w_uri811rtIMMe8LaLDvipZ3oDithO64oLwRtUBVKMZo10DVqBoYaFFhCrR9K7oGBUPEujjLXq66A45y59PQ_iAdGnm5uZZLDFjJS1HXtzSxL1Z2591-1iHKyQSlxxGtdnOQtK4BgJeU_Qcq6oKxBoqEPv8DvXGzt2noheKMF6wof1JbHLU0tnfRo1pE5YZzaGhFWZOo879Q6aTvMMpZ3ZsU_62ArgXKuxC87o9vQEEuCyXXhZKwWFooubTy7K7huZ10d6z4sUEJYCsQUsputf9lon-qfgemp9SZ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1865253234</pqid></control><display><type>article</type><title>Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?</title><source>SpringerNature Journals</source><creator>Jourdil, Jean-Francois ; Lebert, Dorothée ; Gautier-Veyret, Elodie ; Lemaitre, Florian ; Bonaz, Bruno ; Picard, Guillaume ; Tonini, Julia ; Stanke-Labesque, Françoise</creator><creatorcontrib>Jourdil, Jean-Francois ; Lebert, Dorothée ; Gautier-Veyret, Elodie ; Lemaitre, Florian ; Bonaz, Bruno ; Picard, Guillaume ; Tonini, Julia ; Stanke-Labesque, Françoise</creatorcontrib><description>Infliximab (IFX) is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha. It is currently approved for the treatment of certain rheumatic diseases or inflammatory bowel diseases. Clinical studies have suggested that monitoring IFX concentrations could improve treatment response. However, in most studies, IFX was quantified using ELISA assays, the resulting discrepancies of which raised concerns about their reliability. Here, we describe the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for IFX quantification in human plasma. Full-length stable-isotope-labeled antibody (SIL-IFX) was added to plasma samples as internal standard. Samples were then prepared using Mass Spectrometry Immuno Assay (MSIA™) followed by trypsin digestion and submitted to multiple reaction monitoring (MRM) for quantification of IFX. The chromatographic run lasted 13 min. The range of quantification was 1 to 26 mg/L. For two internal quality controls spiked with 6 and 12 mg/L of IFX, the method was reproducible (coefficients of variation (CV%): 12.7 and 2.1), repeatable (intra-day CV%: 5.5 and 5.0), and accurate (inter-day and intra-day deviations from nominal values: +6.4 to +3.7 % and 5.5 to 9.2 %, respectively). There was no cross - contamination effect. Samples from 45 patients treated with IFX were retrospectively analyzed by LC-MS/MS and results were compared to those obtained with an in-house ELISA assay and the commercial Lisa Tracker® method. Good agreement was found between LC-MS/MS and in-house ELISA (mean underestimation of 13 % for in-house ELISA), but a significant bias was found with commercial ELISA (mean underestimation of 136 % for commercial ELISA). This method will make it possible to standardize IFX quantification between laboratories.
Graphical Abstract
Interassay comparison of the three methods: LC-MS/MS vs inhouse ELISA assay or vs Lisa Tracker® ELISA assays, Passing & Bablok (
a
) and Bland & Altman (
b
) for the comparison of LC-MS/MS vs in-house ELISA assay; Passing & Bablok (
c
); Bland & Altman (
d
) for the comparison LC-MS/MS vs Lisa Tracker® ELISA assay</description><identifier>ISSN: 1618-2642</identifier><identifier>EISSN: 1618-2650</identifier><identifier>DOI: 10.1007/s00216-016-0045-4</identifier><identifier>PMID: 27826630</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Analytical Chemistry ; Antibodies ; Assaying ; Biochemistry ; Blood plasma ; Bowel disease ; Characterization and Evaluation of Materials ; Chemical properties ; Chemistry ; Chemistry and Materials Science ; Chromatography ; Chromatography, Liquid ; Composition ; ELISA ; Enzyme-Linked Immunosorbent Assay ; Food Science ; Humans ; Immunoassay ; Infliximab ; Laboratories ; Laboratory Medicine ; Life Sciences ; Liquid chromatography ; Liquids ; Mass spectrometry ; Measurement ; Medical services ; Methods ; Monitoring ; Monitoring/Environmental Analysis ; Peptides ; Pharmaceutical sciences ; Pharmacology ; Plasma ; Proteomics ; Research Paper ; Scientific imaging ; Tandem Mass Spectrometry ; Tumor necrosis factor-TNF</subject><ispartof>Analytical and bioanalytical chemistry, 2017-02, Vol.409 (5), p.1195-1205</ispartof><rights>Springer-Verlag Berlin Heidelberg 2016</rights><rights>(c); Bland & Altman (d) for the comparison LC-MS/MS vs Lisa Tracker® ELISA assay.</rights><rights>COPYRIGHT 2017 Springer</rights><rights>Analytical and Bioanalytical Chemistry is a copyright of Springer, 2017.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c642t-f309afd3b5d0c5176ed56159686ac3c221d9079c8020e67a221bfb6d9a62aaa83</citedby><cites>FETCH-LOGICAL-c642t-f309afd3b5d0c5176ed56159686ac3c221d9079c8020e67a221bfb6d9a62aaa83</cites><orcidid>0000-0003-1858-8941</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00216-016-0045-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00216-016-0045-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27826630$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://univ-rennes.hal.science/hal-02454688$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Jourdil, Jean-Francois</creatorcontrib><creatorcontrib>Lebert, Dorothée</creatorcontrib><creatorcontrib>Gautier-Veyret, Elodie</creatorcontrib><creatorcontrib>Lemaitre, Florian</creatorcontrib><creatorcontrib>Bonaz, Bruno</creatorcontrib><creatorcontrib>Picard, Guillaume</creatorcontrib><creatorcontrib>Tonini, Julia</creatorcontrib><creatorcontrib>Stanke-Labesque, Françoise</creatorcontrib><title>Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?</title><title>Analytical and bioanalytical chemistry</title><addtitle>Anal Bioanal Chem</addtitle><addtitle>Anal Bioanal Chem</addtitle><description>Infliximab (IFX) is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha. It is currently approved for the treatment of certain rheumatic diseases or inflammatory bowel diseases. Clinical studies have suggested that monitoring IFX concentrations could improve treatment response. However, in most studies, IFX was quantified using ELISA assays, the resulting discrepancies of which raised concerns about their reliability. Here, we describe the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for IFX quantification in human plasma. Full-length stable-isotope-labeled antibody (SIL-IFX) was added to plasma samples as internal standard. Samples were then prepared using Mass Spectrometry Immuno Assay (MSIA™) followed by trypsin digestion and submitted to multiple reaction monitoring (MRM) for quantification of IFX. The chromatographic run lasted 13 min. The range of quantification was 1 to 26 mg/L. For two internal quality controls spiked with 6 and 12 mg/L of IFX, the method was reproducible (coefficients of variation (CV%): 12.7 and 2.1), repeatable (intra-day CV%: 5.5 and 5.0), and accurate (inter-day and intra-day deviations from nominal values: +6.4 to +3.7 % and 5.5 to 9.2 %, respectively). There was no cross - contamination effect. Samples from 45 patients treated with IFX were retrospectively analyzed by LC-MS/MS and results were compared to those obtained with an in-house ELISA assay and the commercial Lisa Tracker® method. Good agreement was found between LC-MS/MS and in-house ELISA (mean underestimation of 13 % for in-house ELISA), but a significant bias was found with commercial ELISA (mean underestimation of 136 % for commercial ELISA). This method will make it possible to standardize IFX quantification between laboratories.
Graphical Abstract
Interassay comparison of the three methods: LC-MS/MS vs inhouse ELISA assay or vs Lisa Tracker® ELISA assays, Passing & Bablok (
a
) and Bland & Altman (
b
) for the comparison of LC-MS/MS vs in-house ELISA assay; Passing & Bablok (
c
); Bland & Altman (
d
) for the comparison LC-MS/MS vs Lisa Tracker® ELISA assay</description><subject>Analytical Chemistry</subject><subject>Antibodies</subject><subject>Assaying</subject><subject>Biochemistry</subject><subject>Blood plasma</subject><subject>Bowel disease</subject><subject>Characterization and Evaluation of Materials</subject><subject>Chemical properties</subject><subject>Chemistry</subject><subject>Chemistry and Materials Science</subject><subject>Chromatography</subject><subject>Chromatography, Liquid</subject><subject>Composition</subject><subject>ELISA</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Food Science</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Infliximab</subject><subject>Laboratories</subject><subject>Laboratory Medicine</subject><subject>Life Sciences</subject><subject>Liquid chromatography</subject><subject>Liquids</subject><subject>Mass spectrometry</subject><subject>Measurement</subject><subject>Medical services</subject><subject>Methods</subject><subject>Monitoring</subject><subject>Monitoring/Environmental Analysis</subject><subject>Peptides</subject><subject>Pharmaceutical sciences</subject><subject>Pharmacology</subject><subject>Plasma</subject><subject>Proteomics</subject><subject>Research Paper</subject><subject>Scientific imaging</subject><subject>Tandem Mass Spectrometry</subject><subject>Tumor necrosis 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quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?</title><author>Jourdil, Jean-Francois ; Lebert, Dorothée ; Gautier-Veyret, Elodie ; Lemaitre, Florian ; Bonaz, Bruno ; Picard, Guillaume ; Tonini, Julia ; Stanke-Labesque, Françoise</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c642t-f309afd3b5d0c5176ed56159686ac3c221d9079c8020e67a221bfb6d9a62aaa83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Analytical Chemistry</topic><topic>Antibodies</topic><topic>Assaying</topic><topic>Biochemistry</topic><topic>Blood plasma</topic><topic>Bowel disease</topic><topic>Characterization and Evaluation of Materials</topic><topic>Chemical properties</topic><topic>Chemistry</topic><topic>Chemistry and Materials Science</topic><topic>Chromatography</topic><topic>Chromatography, Liquid</topic><topic>Composition</topic><topic>ELISA</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Food Science</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Infliximab</topic><topic>Laboratories</topic><topic>Laboratory Medicine</topic><topic>Life Sciences</topic><topic>Liquid chromatography</topic><topic>Liquids</topic><topic>Mass spectrometry</topic><topic>Measurement</topic><topic>Medical services</topic><topic>Methods</topic><topic>Monitoring</topic><topic>Monitoring/Environmental Analysis</topic><topic>Peptides</topic><topic>Pharmaceutical sciences</topic><topic>Pharmacology</topic><topic>Plasma</topic><topic>Proteomics</topic><topic>Research Paper</topic><topic>Scientific imaging</topic><topic>Tandem Mass Spectrometry</topic><topic>Tumor necrosis factor-TNF</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jourdil, Jean-Francois</creatorcontrib><creatorcontrib>Lebert, 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chemistry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jourdil, Jean-Francois</au><au>Lebert, Dorothée</au><au>Gautier-Veyret, Elodie</au><au>Lemaitre, Florian</au><au>Bonaz, Bruno</au><au>Picard, Guillaume</au><au>Tonini, Julia</au><au>Stanke-Labesque, Françoise</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?</atitle><jtitle>Analytical and bioanalytical chemistry</jtitle><stitle>Anal Bioanal Chem</stitle><addtitle>Anal Bioanal Chem</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>409</volume><issue>5</issue><spage>1195</spage><epage>1205</epage><pages>1195-1205</pages><issn>1618-2642</issn><eissn>1618-2650</eissn><abstract>Infliximab (IFX) is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha. It is currently approved for the treatment of certain rheumatic diseases or inflammatory bowel diseases. Clinical studies have suggested that monitoring IFX concentrations could improve treatment response. However, in most studies, IFX was quantified using ELISA assays, the resulting discrepancies of which raised concerns about their reliability. Here, we describe the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for IFX quantification in human plasma. Full-length stable-isotope-labeled antibody (SIL-IFX) was added to plasma samples as internal standard. Samples were then prepared using Mass Spectrometry Immuno Assay (MSIA™) followed by trypsin digestion and submitted to multiple reaction monitoring (MRM) for quantification of IFX. The chromatographic run lasted 13 min. The range of quantification was 1 to 26 mg/L. For two internal quality controls spiked with 6 and 12 mg/L of IFX, the method was reproducible (coefficients of variation (CV%): 12.7 and 2.1), repeatable (intra-day CV%: 5.5 and 5.0), and accurate (inter-day and intra-day deviations from nominal values: +6.4 to +3.7 % and 5.5 to 9.2 %, respectively). There was no cross - contamination effect. Samples from 45 patients treated with IFX were retrospectively analyzed by LC-MS/MS and results were compared to those obtained with an in-house ELISA assay and the commercial Lisa Tracker® method. Good agreement was found between LC-MS/MS and in-house ELISA (mean underestimation of 13 % for in-house ELISA), but a significant bias was found with commercial ELISA (mean underestimation of 136 % for commercial ELISA). This method will make it possible to standardize IFX quantification between laboratories.
Graphical Abstract
Interassay comparison of the three methods: LC-MS/MS vs inhouse ELISA assay or vs Lisa Tracker® ELISA assays, Passing & Bablok (
a
) and Bland & Altman (
b
) for the comparison of LC-MS/MS vs in-house ELISA assay; Passing & Bablok (
c
); Bland & Altman (
d
) for the comparison LC-MS/MS vs Lisa Tracker® ELISA assay</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>27826630</pmid><doi>10.1007/s00216-016-0045-4</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-1858-8941</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1618-2642 |
| ispartof | Analytical and bioanalytical chemistry, 2017-02, Vol.409 (5), p.1195-1205 |
| issn | 1618-2642 1618-2650 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_02454688v1 |
| source | SpringerNature Journals |
| subjects | Analytical Chemistry Antibodies Assaying Biochemistry Blood plasma Bowel disease Characterization and Evaluation of Materials Chemical properties Chemistry Chemistry and Materials Science Chromatography Chromatography, Liquid Composition ELISA Enzyme-Linked Immunosorbent Assay Food Science Humans Immunoassay Infliximab Laboratories Laboratory Medicine Life Sciences Liquid chromatography Liquids Mass spectrometry Measurement Medical services Methods Monitoring Monitoring/Environmental Analysis Peptides Pharmaceutical sciences Pharmacology Plasma Proteomics Research Paper Scientific imaging Tandem Mass Spectrometry Tumor necrosis factor-TNF |
| title | Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods? |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T06%3A50%3A31IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Infliximab%20quantitation%20in%20human%20plasma%20by%20liquid%20chromatography-tandem%20mass%20spectrometry:%20towards%20a%20standardization%20of%20the%20methods?&rft.jtitle=Analytical%20and%20bioanalytical%20chemistry&rft.au=Jourdil,%20Jean-Francois&rft.date=2017-02-01&rft.volume=409&rft.issue=5&rft.spage=1195&rft.epage=1205&rft.pages=1195-1205&rft.issn=1618-2642&rft.eissn=1618-2650&rft_id=info:doi/10.1007/s00216-016-0045-4&rft_dat=%3Cgale_hal_p%3EA550917129%3C/gale_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1865253234&rft_id=info:pmid/27826630&rft_galeid=A550917129&rfr_iscdi=true |