Multicenter Evaluation of a New Electrochemiluminescence Immunoassay for Everolimus Concentrations in Whole Blood.
Identifieur interne : 000543 ( Main/Exploration ); précédent : 000542; suivant : 000544Multicenter Evaluation of a New Electrochemiluminescence Immunoassay for Everolimus Concentrations in Whole Blood.
Auteurs : Alain G. Verstraete [Belgique] ; Raül Rigo-Bonnin [Espagne] ; Pierre Wallemacq [Belgique] ; Michael Vogeser [Allemagne] ; Andre Schuetzenmeister ; Christian Schmiedel ; Maria Shipkova [Allemagne]Source :
- Therapeutic drug monitoring [ 1536-3694 ] ; 2018.
Descripteurs français
- KwdFr :
- Chromatographie en phase liquide (MeSH), Dosage immunologique (méthodes), Humains (MeSH), Immunosuppresseurs (sang), Limite de détection (MeSH), Luminescence (MeSH), Microsphères (MeSH), Reproductibilité des résultats (MeSH), Spectrométrie de masse en tandem (MeSH), Surveillance des médicaments (méthodes), Techniques électrochimiques (méthodes), Évérolimus (sang).
- MESH :
English descriptors
- KwdEn :
- Chromatography, Liquid (MeSH), Drug Monitoring (methods), Electrochemical Techniques (methods), Everolimus (blood), Humans (MeSH), Immunoassay (methods), Immunosuppressive Agents (blood), Limit of Detection (MeSH), Luminescence (MeSH), Microspheres (MeSH), Reproducibility of Results (MeSH), Tandem Mass Spectrometry (MeSH).
- MESH :
- chemical , blood : Everolimus, Immunosuppressive Agents.
- methods : Drug Monitoring, Electrochemical Techniques, Immunoassay.
- Chromatography, Liquid, Humans, Limit of Detection, Luminescence, Microspheres, Reproducibility of Results, Tandem Mass Spectrometry.
Abstract
BACKGROUND
The precise monitoring of everolimus, an immunosuppressant drug, is vital for transplant recipients due to its narrow therapeutic range. This study evaluated the analytical performance of a new electrochemiluminescence immunoassay (ECLIA) for everolimus concentrations in whole blood.
METHODS
Accuracy, imprecision, and sensitivity studies for the Roche Elecsys everolimus ECLIA were performed at 5 European laboratories. The ECLIA was compared with liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods, as well as the Quantitative Microsphere System everolimus assay.
RESULTS
Everolimus ECLIA accuracies were within the range 100% ± 9%. Coefficients of variation (CVs) across the target range were ≤4.8% for repeatability and ≤8.4% for intermediate imprecision, whereas multisite reproducibility at lower (2.71 mcg/L) and higher everolimus concentrations (3.0-30.0 mcg/L) resulted in CVs of ≤13.7% and ≤12.4%, respectively. The CV at the assay's lower limit of quantification without considering bias was excellent, estimated as ≤9.3% at 0.5 mcg/L. The weighted Deming regression analysis, used for comparison of the results obtained by everolimus ECLIA and by LC-MS/MS methods, yielded a slope of 1.21 [95% confidence interval (CI): 1.15-1.26], intercept of 0.478 mcg/L (95% CI: 0.241-0.716), and a Pearson correlation coefficient (r) of 0.91. A single-site comparison between the ECLIA and the Quantitative Microsphere System assay revealed a slope of 1.05 (95% CI: 0.917-1.17), intercept of 1.03 mcg/L (95% CI: 0.351-1.70), and r of 0.91.
CONCLUSIONS
Based on these results, the Roche Elecsys everolimus ECLIA can be considered suitable for routine therapeutic drug monitoring. A positive bias was observed with respect to LC-MS/MS methods, suggesting that it may be necessary to rebaseline individual patients when switching from LC-MS/MS to the ECLIA; however, this must also be considered for any change of method for everolimus measurement.
DOI: 10.1097/FTD.0000000000000474
PubMed: 29210975
Affiliations:
- Allemagne, Belgique, Espagne
- Bade-Wurtemberg, Bavière, Catalogne, District de Haute-Bavière, District de Stuttgart, Région de Bruxelles-Capitale
- Barcelone, Bruxelles, Munich, Stuttgart
Links toward previous steps (curation, corpus...)
Le document en format XML
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Verstraete</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Chemistry, Microbiology and Immunology, Ghent University and Ghent University Hospital, Ghent, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Clinical Chemistry, Microbiology and Immunology, Ghent University and Ghent University Hospital, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Rigo Bonnin, Raul" sort="Rigo Bonnin, Raul" uniqKey="Rigo Bonnin R" first="Raül" last="Rigo-Bonnin">Raül Rigo-Bonnin</name><affiliation wicri:level="3"><nlm:affiliation>Laboratori Clinic-IDIBELL, Hospital Universitari de Bellvitge, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Laboratori Clinic-IDIBELL, Hospital Universitari de Bellvitge, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Wallemacq, Pierre" sort="Wallemacq, Pierre" uniqKey="Wallemacq P" first="Pierre" last="Wallemacq">Pierre Wallemacq</name><affiliation wicri:level="3"><nlm:affiliation>Cliniques Universitaires St. Luc, Brussels, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires St. Luc, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Vogeser, Michael" sort="Vogeser, Michael" uniqKey="Vogeser M" first="Michael" last="Vogeser">Michael Vogeser</name><affiliation wicri:level="3"><nlm:affiliation>Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich.</nlm:affiliation><country>Allemagne</country><placeName><settlement type="city">Munich</settlement><region type="land" 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first="Maria" last="Shipkova">Maria Shipkova</name><affiliation wicri:level="3"><nlm:affiliation>Central Institute for Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Stuttgart, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Central Institute for Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Stuttgart</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Stuttgart</region><settlement type="city">Stuttgart</settlement></placeName></affiliation></author></analytic><series><title level="j">Therapeutic drug monitoring</title><idno type="eISSN">1536-3694</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Chromatography, Liquid (MeSH)</term><term>Drug Monitoring (methods)</term><term>Electrochemical Techniques (methods)</term><term>Everolimus (blood)</term><term>Humans (MeSH)</term><term>Immunoassay (methods)</term><term>Immunosuppressive Agents (blood)</term><term>Limit of Detection (MeSH)</term><term>Luminescence (MeSH)</term><term>Microspheres (MeSH)</term><term>Reproducibility of Results (MeSH)</term><term>Tandem Mass Spectrometry (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Chromatographie en phase liquide (MeSH)</term><term>Dosage immunologique (méthodes)</term><term>Humains (MeSH)</term><term>Immunosuppresseurs (sang)</term><term>Limite de détection (MeSH)</term><term>Luminescence (MeSH)</term><term>Microsphères (MeSH)</term><term>Reproductibilité des résultats (MeSH)</term><term>Spectrométrie de masse en tandem (MeSH)</term><term>Surveillance des médicaments (méthodes)</term><term>Techniques électrochimiques (méthodes)</term><term>Évérolimus (sang)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Everolimus</term><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Monitoring</term><term>Electrochemical Techniques</term><term>Immunoassay</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Dosage immunologique</term><term>Surveillance des médicaments</term><term>Techniques électrochimiques</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Immunosuppresseurs</term><term>Évérolimus</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Chromatography, Liquid</term><term>Humans</term><term>Limit of Detection</term><term>Luminescence</term><term>Microspheres</term><term>Reproducibility of Results</term><term>Tandem Mass Spectrometry</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Chromatographie en phase liquide</term><term>Humains</term><term>Limite de détection</term><term>Luminescence</term><term>Microsphères</term><term>Reproductibilité des résultats</term><term>Spectrométrie de masse en tandem</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>The precise monitoring of everolimus, an immunosuppressant drug, is vital for transplant recipients due to its narrow therapeutic range. This study evaluated the analytical performance of a new electrochemiluminescence immunoassay (ECLIA) for everolimus concentrations in whole blood.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Accuracy, imprecision, and sensitivity studies for the Roche Elecsys everolimus ECLIA were performed at 5 European laboratories. The ECLIA was compared with liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods, as well as the Quantitative Microsphere System everolimus assay.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Everolimus ECLIA accuracies were within the range 100% ± 9%. Coefficients of variation (CVs) across the target range were ≤4.8% for repeatability and ≤8.4% for intermediate imprecision, whereas multisite reproducibility at lower (2.71 mcg/L) and higher everolimus concentrations (3.0-30.0 mcg/L) resulted in CVs of ≤13.7% and ≤12.4%, respectively. The CV at the assay's lower limit of quantification without considering bias was excellent, estimated as ≤9.3% at 0.5 mcg/L. The weighted Deming regression analysis, used for comparison of the results obtained by everolimus ECLIA and by LC-MS/MS methods, yielded a slope of 1.21 [95% confidence interval (CI): 1.15-1.26], intercept of 0.478 mcg/L (95% CI: 0.241-0.716), and a Pearson correlation coefficient (r) of 0.91. A single-site comparison between the ECLIA and the Quantitative Microsphere System assay revealed a slope of 1.05 (95% CI: 0.917-1.17), intercept of 1.03 mcg/L (95% CI: 0.351-1.70), and r of 0.91.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Based on these results, the Roche Elecsys everolimus ECLIA can be considered suitable for routine therapeutic drug monitoring. A positive bias was observed with respect to LC-MS/MS methods, suggesting that it may be necessary to rebaseline individual patients when switching from LC-MS/MS to the ECLIA; however, this must also be considered for any change of method for everolimus measurement.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">29210975</PMID><DateCompleted><Year>2018</Year><Month>11</Month><Day>09</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>09</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1536-3694</ISSN><JournalIssue CitedMedium="Internet"><Volume>40</Volume><Issue>1</Issue><PubDate><Year>2018</Year><Month>02</Month></PubDate></JournalIssue><Title>Therapeutic drug monitoring</Title><ISOAbbreviation>Ther Drug Monit</ISOAbbreviation></Journal><ArticleTitle>Multicenter Evaluation of a New Electrochemiluminescence Immunoassay for Everolimus Concentrations in Whole Blood.</ArticleTitle><Pagination><MedlinePgn>59-68</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/FTD.0000000000000474</ELocationID><Abstract><AbstractText Label="BACKGROUND">The precise monitoring of everolimus, an immunosuppressant drug, is vital for transplant recipients due to its narrow therapeutic range. This study evaluated the analytical performance of a new electrochemiluminescence immunoassay (ECLIA) for everolimus concentrations in whole blood.</AbstractText><AbstractText Label="METHODS">Accuracy, imprecision, and sensitivity studies for the Roche Elecsys everolimus ECLIA were performed at 5 European laboratories. The ECLIA was compared with liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods, as well as the Quantitative Microsphere System everolimus assay.</AbstractText><AbstractText Label="RESULTS">Everolimus ECLIA accuracies were within the range 100% ± 9%. Coefficients of variation (CVs) across the target range were ≤4.8% for repeatability and ≤8.4% for intermediate imprecision, whereas multisite reproducibility at lower (2.71 mcg/L) and higher everolimus concentrations (3.0-30.0 mcg/L) resulted in CVs of ≤13.7% and ≤12.4%, respectively. The CV at the assay's lower limit of quantification without considering bias was excellent, estimated as ≤9.3% at 0.5 mcg/L. The weighted Deming regression analysis, used for comparison of the results obtained by everolimus ECLIA and by LC-MS/MS methods, yielded a slope of 1.21 [95% confidence interval (CI): 1.15-1.26], intercept of 0.478 mcg/L (95% CI: 0.241-0.716), and a Pearson correlation coefficient (r) of 0.91. A single-site comparison between the ECLIA and the Quantitative Microsphere System assay revealed a slope of 1.05 (95% CI: 0.917-1.17), intercept of 1.03 mcg/L (95% CI: 0.351-1.70), and r of 0.91.</AbstractText><AbstractText Label="CONCLUSIONS">Based on these results, the Roche Elecsys everolimus ECLIA can be considered suitable for routine therapeutic drug monitoring. A positive bias was observed with respect to LC-MS/MS methods, suggesting that it may be necessary to rebaseline individual patients when switching from LC-MS/MS to the ECLIA; however, this must also be considered for any change of method for everolimus measurement.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Verstraete</LastName><ForeName>Alain G</ForeName><Initials>AG</Initials><AffiliationInfo><Affiliation>Department of Clinical Chemistry, Microbiology and Immunology, Ghent University and Ghent University Hospital, Ghent, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rigo-Bonnin</LastName><ForeName>Raül</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Laboratori Clinic-IDIBELL, Hospital Universitari de Bellvitge, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wallemacq</LastName><ForeName>Pierre</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Cliniques Universitaires St. Luc, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vogeser</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schuetzenmeister</LastName><ForeName>Andre</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Centralised and Point of Care Solutions, Roche Diagnostics GmbH.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schmiedel</LastName><ForeName>Christian</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>IST GmbH, Mannheim.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shipkova</LastName><ForeName>Maria</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Central Institute for Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Stuttgart, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Ther Drug Monit</MedlineTA><NlmUniqueID>7909660</NlmUniqueID><ISSNLinking>0163-4356</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>9HW64Q8G6G</RegistryNumber><NameOfSubstance UI="D000068338">Everolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D002853" MajorTopicYN="N">Chromatography, Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016903" MajorTopicYN="N">Drug Monitoring</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055664" MajorTopicYN="N">Electrochemical Techniques</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068338" MajorTopicYN="N">Everolimus</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007118" MajorTopicYN="N">Immunoassay</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007166" MajorTopicYN="N">Immunosuppressive Agents</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057230" MajorTopicYN="N">Limit of Detection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D049449" MajorTopicYN="Y">Luminescence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008863" MajorTopicYN="Y">Microspheres</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053719" MajorTopicYN="N">Tandem Mass Spectrometry</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>12</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>11</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>12</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">29210975</ArticleId><ArticleId IdType="doi">10.1097/FTD.0000000000000474</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Espagne</li></country><region><li>Bade-Wurtemberg</li><li>Bavière</li><li>Catalogne</li><li>District de Haute-Bavière</li><li>District de Stuttgart</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Barcelone</li><li>Bruxelles</li><li>Munich</li><li>Stuttgart</li></settlement></list><tree><noCountry><name sortKey="Schmiedel, Christian" sort="Schmiedel, Christian" uniqKey="Schmiedel C" first="Christian" last="Schmiedel">Christian Schmiedel</name><name sortKey="Schuetzenmeister, Andre" sort="Schuetzenmeister, Andre" uniqKey="Schuetzenmeister A" first="Andre" last="Schuetzenmeister">Andre Schuetzenmeister</name></noCountry><country name="Belgique"><noRegion><name sortKey="Verstraete, Alain G" sort="Verstraete, Alain G" uniqKey="Verstraete A" first="Alain G" last="Verstraete">Alain G. Verstraete</name></noRegion><name sortKey="Wallemacq, Pierre" sort="Wallemacq, Pierre" uniqKey="Wallemacq P" first="Pierre" last="Wallemacq">Pierre Wallemacq</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Rigo Bonnin, Raul" sort="Rigo Bonnin, Raul" uniqKey="Rigo Bonnin R" first="Raül" last="Rigo-Bonnin">Raül Rigo-Bonnin</name></region></country><country name="Allemagne"><region name="Bavière"><name sortKey="Vogeser, Michael" sort="Vogeser, Michael" uniqKey="Vogeser M" first="Michael" last="Vogeser">Michael Vogeser</name></region><name sortKey="Shipkova, Maria" sort="Shipkova, Maria" uniqKey="Shipkova M" first="Maria" last="Shipkova">Maria Shipkova</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:29210975" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a RapamycinFungusV1
| This area was generated with Dilib version V0.6.38. |  |