Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays
Summary Background Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti‐drug antibody monitoring is hampered by lack of standardisation. Aim To determine the correlation between three different assays fo...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2012-10, Vol.36 (8), p.765-771 |
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| creator | Vande Casteele, N. Buurman, D. J. Sturkenboom, M. G. G. Kleibeuker, J. H. Vermeire, S. Rispens, T. van der Kleij, D. Gils, A. Dijkstra, G. |
| description | Summary
Background
Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti‐drug antibody monitoring is hampered by lack of standardisation.
Aim
To determine the correlation between three different assays for measuring infliximab and ATI.
Methods
Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands.
Results
All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C.
Conclusions
There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples. |
| doi_str_mv | 10.1111/apt.12030 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1041142018</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1041142018</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4590-f976e632e2566eb49f7e0ac3c1663f20ec4aa7656150c43dda75d78d306166443</originalsourceid><addsrcrecordid>eNp1kE9v1DAQxS0EokvpgS9Q5YJUDmn9J7YTbm2BAq0Kh6IiLtasM1YN2WTryUL32-M229ILI1ljy7_3RvMYeyX4vsh1AMtxX0iu-BM2E8roMt_NUzbj0jSlrIXaYi-IfnLOjeXyOduSspG1rsWM4Tsc0Y9x6IshFLEPXbyJC5gXHf7Gjgro23zGWD76un3PhzYivS2g8MNiCSnS5DBeJcSijSFgwn4sgAjW9JI9C9AR7mz6Nvv24f3F8cfy7MvJp-PDs9JXuuFlaKxBoyRKbQzOqyZY5OCVF8aoIDn6CsAabYTmvlJtC1a3tm4VN5moKrXN9ibfZRquV0ijW0Ty2HXQ47AiJ3glRCW5qDP6ZkJ9GogSBrdMebu0zpC7TdXlVN1dqpnd3diu5gtsH8j7GDPwegMAeehCgt5H-scZZfNaKnMHE_cndrj-_0R3-PXifnQ5KSKNePOggPTLGausdpfnJ05-PtLfzy9_uFP1F99SnS0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1041142018</pqid></control><display><type>article</type><title>Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays</title><source>MEDLINE</source><source>Wiley Online Library Free Content</source><source>Wiley-Blackwell Full Collection</source><source>EZB Electronic Journals Library</source><creator>Vande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.</creator><creatorcontrib>Vande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.</creatorcontrib><description>Summary
Background
Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti‐drug antibody monitoring is hampered by lack of standardisation.
Aim
To determine the correlation between three different assays for measuring infliximab and ATI.
Methods
Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands.
Results
All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C.
Conclusions
There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.12030</identifier><identifier>PMID: 22928581</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Anti-Inflammatory Agents, Non-Steroidal - blood ; Anti-Inflammatory Agents, Non-Steroidal - immunology ; Antibodies - blood ; Antibodies, Monoclonal - blood ; Antibodies, Monoclonal - immunology ; Antigen-Antibody Reactions ; Biological and medical sciences ; Biomarkers - blood ; Digestive system ; False Positive Reactions ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Immunoassay - methods ; Infliximab ; Medical sciences ; Pharmacology. Drug treatments ; Reagent Kits, Diagnostic - standards ; Statistics as Topic</subject><ispartof>Alimentary pharmacology & therapeutics, 2012-10, Vol.36 (8), p.765-771</ispartof><rights>2012 Blackwell Publishing Ltd</rights><rights>2015 INIST-CNRS</rights><rights>2012 Blackwell Publishing Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4590-f976e632e2566eb49f7e0ac3c1663f20ec4aa7656150c43dda75d78d306166443</citedby><cites>FETCH-LOGICAL-c4590-f976e632e2566eb49f7e0ac3c1663f20ec4aa7656150c43dda75d78d306166443</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.12030$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.12030$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,1434,27929,27930,45579,45580,46414,46838</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26376323$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22928581$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vande Casteele, N.</creatorcontrib><creatorcontrib>Buurman, D. J.</creatorcontrib><creatorcontrib>Sturkenboom, M. G. G.</creatorcontrib><creatorcontrib>Kleibeuker, J. H.</creatorcontrib><creatorcontrib>Vermeire, S.</creatorcontrib><creatorcontrib>Rispens, T.</creatorcontrib><creatorcontrib>van der Kleij, D.</creatorcontrib><creatorcontrib>Gils, A.</creatorcontrib><creatorcontrib>Dijkstra, G.</creatorcontrib><title>Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background
Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti‐drug antibody monitoring is hampered by lack of standardisation.
Aim
To determine the correlation between three different assays for measuring infliximab and ATI.
Methods
Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands.
Results
All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C.
Conclusions
There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples.</description><subject>Anti-Inflammatory Agents, Non-Steroidal - blood</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - immunology</subject><subject>Antibodies - blood</subject><subject>Antibodies, Monoclonal - blood</subject><subject>Antibodies, Monoclonal - immunology</subject><subject>Antigen-Antibody Reactions</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - blood</subject><subject>Digestive system</subject><subject>False Positive Reactions</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Immunoassay - methods</subject><subject>Infliximab</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Reagent Kits, Diagnostic - standards</subject><subject>Statistics as Topic</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kE9v1DAQxS0EokvpgS9Q5YJUDmn9J7YTbm2BAq0Kh6IiLtasM1YN2WTryUL32-M229ILI1ljy7_3RvMYeyX4vsh1AMtxX0iu-BM2E8roMt_NUzbj0jSlrIXaYi-IfnLOjeXyOduSspG1rsWM4Tsc0Y9x6IshFLEPXbyJC5gXHf7Gjgro23zGWD76un3PhzYivS2g8MNiCSnS5DBeJcSijSFgwn4sgAjW9JI9C9AR7mz6Nvv24f3F8cfy7MvJp-PDs9JXuuFlaKxBoyRKbQzOqyZY5OCVF8aoIDn6CsAabYTmvlJtC1a3tm4VN5moKrXN9ibfZRquV0ijW0Ty2HXQ47AiJ3glRCW5qDP6ZkJ9GogSBrdMebu0zpC7TdXlVN1dqpnd3diu5gtsH8j7GDPwegMAeehCgt5H-scZZfNaKnMHE_cndrj-_0R3-PXifnQ5KSKNePOggPTLGausdpfnJ05-PtLfzy9_uFP1F99SnS0</recordid><startdate>201210</startdate><enddate>201210</enddate><creator>Vande Casteele, N.</creator><creator>Buurman, D. J.</creator><creator>Sturkenboom, M. G. G.</creator><creator>Kleibeuker, J. H.</creator><creator>Vermeire, S.</creator><creator>Rispens, T.</creator><creator>van der Kleij, D.</creator><creator>Gils, A.</creator><creator>Dijkstra, G.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201210</creationdate><title>Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays</title><author>Vande Casteele, N. ; Buurman, D. J. ; Sturkenboom, M. G. G. ; Kleibeuker, J. H. ; Vermeire, S. ; Rispens, T. ; van der Kleij, D. ; Gils, A. ; Dijkstra, G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4590-f976e632e2566eb49f7e0ac3c1663f20ec4aa7656150c43dda75d78d306166443</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Anti-Inflammatory Agents, Non-Steroidal - blood</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - immunology</topic><topic>Antibodies - blood</topic><topic>Antibodies, Monoclonal - blood</topic><topic>Antibodies, Monoclonal - immunology</topic><topic>Antigen-Antibody Reactions</topic><topic>Biological and medical sciences</topic><topic>Biomarkers - blood</topic><topic>Digestive system</topic><topic>False Positive Reactions</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Immunoassay - methods</topic><topic>Infliximab</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Reagent Kits, Diagnostic - standards</topic><topic>Statistics as Topic</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vande Casteele, N.</creatorcontrib><creatorcontrib>Buurman, D. J.</creatorcontrib><creatorcontrib>Sturkenboom, M. G. G.</creatorcontrib><creatorcontrib>Kleibeuker, J. H.</creatorcontrib><creatorcontrib>Vermeire, S.</creatorcontrib><creatorcontrib>Rispens, T.</creatorcontrib><creatorcontrib>van der Kleij, D.</creatorcontrib><creatorcontrib>Gils, A.</creatorcontrib><creatorcontrib>Dijkstra, G.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vande Casteele, N.</au><au>Buurman, D. J.</au><au>Sturkenboom, M. G. G.</au><au>Kleibeuker, J. H.</au><au>Vermeire, S.</au><au>Rispens, T.</au><au>van der Kleij, D.</au><au>Gils, A.</au><au>Dijkstra, G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2012-10</date><risdate>2012</risdate><volume>36</volume><issue>8</issue><spage>765</spage><epage>771</epage><pages>765-771</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background
Formation of antibodies to infliximab (ATI) inversely correlates with functional drug levels and clinical outcome. Comparison of drug levels and anti‐drug antibody monitoring is hampered by lack of standardisation.
Aim
To determine the correlation between three different assays for measuring infliximab and ATI.
Methods
Serum samples and spiked controls (total 62) were evaluated in a blinded way in infliximab and ATI assays developed by Sanquin Amsterdam, Netherlands (A), Laboratory for Pharmaceutical Biology, KU Leuven, Belgium (B) and a commercially available kit from Biomedical Diagnostics (BMD), Paris, France (C) performed by the University Medical Center Groningen (UMCG), Netherlands.
Results
All infliximab assays showed a linear quantitative correlation (Pearson r = 0.91 for A vs. B, 0.83 for A vs. C and 0.73 for B vs. C). Assay C detected infliximab in 11 samples (18%) not detected by A and B, including samples containing only ATI. All ATI assays showed a good linear correlation (Pearson r = 0.95 for A vs. B, 0.99 for A vs. C and 0.97 for B vs. C). Assay A detected ATI in five samples with low ATI that were not detected by assays B and C. Assay B did not detect ATI in three patient samples with low ATI according to assays A and C.
Conclusions
There is a good correlation of infliximab and antibodies to infliximab measurements between these assays. Nevertheless, the Biomedical Diagnostics kit detected false positive infliximab levels in 18% of the samples.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><pmid>22928581</pmid><doi>10.1111/apt.12030</doi><tpages>7</tpages></addata></record> |
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| source | MEDLINE; Wiley Online Library Free Content; Wiley-Blackwell Full Collection; EZB Electronic Journals Library |
| subjects | Anti-Inflammatory Agents, Non-Steroidal - blood Anti-Inflammatory Agents, Non-Steroidal - immunology Antibodies - blood Antibodies, Monoclonal - blood Antibodies, Monoclonal - immunology Antigen-Antibody Reactions Biological and medical sciences Biomarkers - blood Digestive system False Positive Reactions Gastroenterology. Liver. Pancreas. Abdomen Humans Immunoassay - methods Infliximab Medical sciences Pharmacology. Drug treatments Reagent Kits, Diagnostic - standards Statistics as Topic |
| title | Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays |
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