Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine
Identifieur interne : 000231 ( Ncbi/Merge ); précédent : 000230; suivant : 000232Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine
Auteurs : Michael Vogeser [Allemagne] ; Maria Shipkova [Allemagne] ; Raül Rigo-Bonnin [Espagne] ; Pierre Wallemacq [Belgique] ; Matthias Orth [Allemagne] ; Monika Widmann [Allemagne] ; Alain G. Verstraete [Belgique]Source :
- Therapeutic Drug Monitoring [ 0163-4356 ] ; 2014.
Abstract
Supplemental Digital Content is Available in the Text.
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DOI: 10.1097/FTD.0000000000000068
PubMed: 24646730
PubMed Central: 4218761
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine</title><author><name sortKey="Vogeser, Michael" sort="Vogeser, Michael" uniqKey="Vogeser M" first="Michael" last="Vogeser">Michael Vogeser</name><affiliation wicri:level="4"><nlm:aff id="aff1">Hospital of the University of Munich, Institute of Laboratory Medicine;</nlm:aff><orgName type="university">Université Louis-et-Maximilien de Munich</orgName><country>Allemagne</country><placeName><settlement type="city">Munich</settlement><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region></placeName></affiliation></author><author><name sortKey="Shipkova, Maria" sort="Shipkova, Maria" uniqKey="Shipkova M" first="Maria" last="Shipkova">Maria Shipkova</name><affiliation wicri:level="1"><nlm:aff id="aff2">Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Germany;</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart</wicri:regionArea><wicri:noRegion>Klinikum-Stuttgart</wicri:noRegion><wicri:noRegion>Klinikum-Stuttgart</wicri:noRegion><wicri:noRegion>Klinikum-Stuttgart</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:aff id="aff3">Laboratori Clínic Department, Hospital Universitari de Bellvitge, Barcelona, Spain;</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Laboratori Clínic Department, 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:aff id="aff4">Cliniques Universitaires St. Luc, Louvain Toxicology and Applied Pharmacology, Université Catholique de Louvain, Brussels, Belgium;</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires St. Luc, Louvain Toxicology and Applied Pharmacology, Université Catholique de Louvain, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Orth, Matthias" sort="Orth, Matthias" uniqKey="Orth M" first="Matthias" last="Orth">Matthias Orth</name><affiliation wicri:level="3"><nlm:aff id="aff5">Institue for Laboratory Medicine, Marienhospital, Stuttgart;</nlm:aff><country>Allemagne</country><placeName><settlement type="city">Stuttgart</settlement><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Stuttgart</region></placeName><wicri:orgArea>Institue for Laboratory Medicine, Marienhospital</wicri:orgArea></affiliation></author><author><name sortKey="Widmann, Monika" sort="Widmann, Monika" uniqKey="Widmann M" first="Monika" last="Widmann">Monika Widmann</name><affiliation wicri:level="3"><nlm:aff wicri:cut="; and" id="aff6">Roche Diagnostics GmbH, Mannheim, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Roche Diagnostics GmbH, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Verstraete, Alain G" sort="Verstraete, Alain G" uniqKey="Verstraete A" first="Alain G." last="Verstraete">Alain G. Verstraete</name><affiliation wicri:level="1"><nlm:aff id="aff7">Department of Laboratory Medicine, Ghent University and Ghent University Hospital, Belgium.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Department of Laboratory Medicine, Ghent University and Ghent University Hospital</wicri:regionArea><wicri:noRegion>Ghent University and Ghent University Hospital</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24646730</idno><idno type="pmc">4218761</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4218761</idno><idno type="RBID">PMC:4218761</idno><idno type="doi">10.1097/FTD.0000000000000068</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000434</idno><idno type="wicri:Area/Pmc/Curation">000434</idno><idno type="wicri:Area/Pmc/Checkpoint">000195</idno><idno type="wicri:Area/Ncbi/Merge">000231</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine</title><author><name sortKey="Vogeser, Michael" sort="Vogeser, Michael" uniqKey="Vogeser M" first="Michael" last="Vogeser">Michael Vogeser</name><affiliation wicri:level="4"><nlm:aff id="aff1">Hospital of the University of Munich, Institute of Laboratory Medicine;</nlm:aff><orgName type="university">Université Louis-et-Maximilien de Munich</orgName><country>Allemagne</country><placeName><settlement type="city">Munich</settlement><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region></placeName></affiliation></author><author><name sortKey="Shipkova, Maria" sort="Shipkova, Maria" uniqKey="Shipkova M" first="Maria" last="Shipkova">Maria Shipkova</name><affiliation wicri:level="1"><nlm:aff id="aff2">Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Germany;</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart</wicri:regionArea><wicri:noRegion>Klinikum-Stuttgart</wicri:noRegion><wicri:noRegion>Klinikum-Stuttgart</wicri:noRegion><wicri:noRegion>Klinikum-Stuttgart</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:aff id="aff3">Laboratori Clínic Department, Hospital Universitari de Bellvitge, Barcelona, Spain;</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Laboratori Clínic Department, 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:aff id="aff4">Cliniques Universitaires St. Luc, Louvain Toxicology and Applied Pharmacology, Université Catholique de Louvain, Brussels, Belgium;</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Cliniques Universitaires St. Luc, Louvain Toxicology and Applied Pharmacology, Université Catholique de Louvain, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Orth, Matthias" sort="Orth, Matthias" uniqKey="Orth M" first="Matthias" last="Orth">Matthias Orth</name><affiliation wicri:level="3"><nlm:aff id="aff5">Institue for Laboratory Medicine, Marienhospital, Stuttgart;</nlm:aff><country>Allemagne</country><placeName><settlement type="city">Stuttgart</settlement><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Stuttgart</region></placeName><wicri:orgArea>Institue for Laboratory Medicine, Marienhospital</wicri:orgArea></affiliation></author><author><name sortKey="Widmann, Monika" sort="Widmann, Monika" uniqKey="Widmann M" first="Monika" last="Widmann">Monika Widmann</name><affiliation wicri:level="3"><nlm:aff wicri:cut="; and" id="aff6">Roche Diagnostics GmbH, Mannheim, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Roche Diagnostics GmbH, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Verstraete, Alain G" sort="Verstraete, Alain G" uniqKey="Verstraete A" first="Alain G." last="Verstraete">Alain G. Verstraete</name><affiliation wicri:level="1"><nlm:aff id="aff7">Department of Laboratory Medicine, Ghent University and Ghent University Hospital, Belgium.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Belgique</country><wicri:regionArea>Department of Laboratory Medicine, Ghent University and Ghent University Hospital</wicri:regionArea><wicri:noRegion>Ghent University and Ghent University Hospital</wicri:noRegion></affiliation></author></analytic><series><title level="j">Therapeutic Drug Monitoring</title><idno type="ISSN">0163-4356</idno><idno type="eISSN">1536-3694</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Supplemental Digital Content is Available in the Text.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Abendroth, D" uniqKey="Abendroth D">D 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ther Drug Monit</journal-id><journal-id journal-id-type="iso-abbrev">Ther Drug Monit</journal-id><journal-id journal-id-type="publisher-id">tdm</journal-id><journal-title-group><journal-title>Therapeutic Drug Monitoring</journal-title></journal-title-group><issn pub-type="ppub">0163-4356</issn><issn pub-type="epub">1536-3694</issn><publisher><publisher-name>Therapeutic Drug Monitoring</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24646730</article-id><article-id pub-id-type="pmc">4218761</article-id><article-id pub-id-type="publisher-id">TDM13-121-Oe</article-id><article-id pub-id-type="doi">10.1097/FTD.0000000000000068</article-id><article-id pub-id-type="art-access-id">00013</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Vogeser</surname><given-names>Michael</given-names></name><degrees>Dr. med.</degrees><xref ref-type="aff" rid="aff1">*</xref></contrib><contrib contrib-type="author"><name><surname>Shipkova</surname><given-names>Maria</given-names></name><degrees>Dr. med.</degrees><xref ref-type="aff" rid="aff2">†</xref></contrib><contrib contrib-type="author"><name><surname>Rigo-Bonnin</surname><given-names>Raül</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff3">‡</xref></contrib><contrib contrib-type="author"><name><surname>Wallemacq</surname><given-names>Pierre</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="aff4">§</xref></contrib><contrib contrib-type="author"><name><surname>Orth</surname><given-names>Matthias</given-names></name><degrees>Dr. med.</degrees><xref ref-type="aff" rid="aff5">¶</xref></contrib><contrib contrib-type="author"><name><surname>Widmann</surname><given-names>Monika</given-names></name><degrees>ChTech</degrees><xref ref-type="aff" rid="aff6">‖</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Verstraete</surname><given-names>Alain G.</given-names></name><degrees>Dr. med., PhD</degrees><xref ref-type="aff" rid="aff7">**</xref></contrib><aff id="aff1"><label>*</label>Hospital of the University of Munich, Institute of Laboratory Medicine;</aff><aff id="aff2"><label>†</label>Central Institute of Clinical Chemistry and Laboratory Medicine, Klinikum-Stuttgart, Germany;</aff><aff id="aff3"><label>‡</label>Laboratori Clínic Department, Hospital Universitari de Bellvitge, Barcelona, Spain;</aff><aff id="aff4"><label>§</label>Cliniques Universitaires St. Luc, Louvain Toxicology and Applied Pharmacology, Université Catholique de Louvain, Brussels, Belgium;</aff><aff id="aff5"><label>¶</label>Institue for Laboratory Medicine, Marienhospital, Stuttgart;</aff><aff id="aff6"><label>‖</label>Roche Diagnostics GmbH, Mannheim, Germany; and</aff><aff id="aff7"><label>**</label>Department of Laboratory Medicine, Ghent University and Ghent University Hospital, Belgium.</aff></contrib-group><author-notes><corresp>Correspondence: Alain G. Verstraete, Dr. med., PhD, Department of Laboratory Medicine, Ghent University, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent, Belgium (e-mail: <email>alain.verstraete@ugent.be</email>).</corresp></author-notes><pub-date pub-type="ppub"><month>10</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>25</day><month>9</month><year>2014</year></pub-date><volume>36</volume><issue>5</issue><fpage>640</fpage><lpage>650</lpage><history><date date-type="received"><day>28</day><month>10</month><year>2013</year></date><date date-type="accepted"><day>12</day><month>3</month><year>2014</year></date></history><permissions><copyright-statement>Copyright © 2014 by Lippincott Williams & Wilkins</copyright-statement><copyright-year>2014</copyright-year><license license-type="open-access"><license-p>This is an open access article distributed under the terms of the Creative Commons Attribution-Noncommercial No Derivative 3.0 License, which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.</license-p></license></permissions><self-uri xlink:type="simple" xlink:href="tdm-36-640.pdf"></self-uri><abstract abstract-type="toc"><p>Supplemental Digital Content is Available in the Text.</p></abstract><abstract><sec><title>Background:</title><p>Cyclosporine A (CsA) is used as a posttransplantation immunosuppressant drug, and careful monitoring of CsA concentration in whole blood is essential. A new automated electrochemiluminescence immunoassay (ECLIA) for CsA measurement has been assessed in a multicenter evaluation.</p></sec><sec><title>Methods:</title><p>Residual EDTA whole blood samples from patients undergoing CsA therapy after organ transplant were used in assay evaluation at 5 clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), lower limit of quantification, linearity according to CLSI EP6-A, and recovery of commercial external quality control samples. In addition, comparisons to liquid chromatography-tandem mass spectrometry methods in routine use at each investigational site and to commercial chemiluminescent microparticle immunoassay and antibody-conjugated magnetic immunoassay methods were performed.</p></sec><sec><title>Results:</title><p>Imprecision testing gave coefficients of variation of less than 9% in the 30–2000 mcg/L range for both within-run and intermediate imprecision. Lower limit of quantification of 6.8 mcg/L at one investigational site and 1.8 mcg/L at a second site at 20% coefficient of variation were observed. Linearity was measured over the concentration range 0–2000 mcg/L, yielding a deviation of less than ±12%. External quality control sample recovery by ECLIA was 93%–114% of LC-MS/MS sample recovery. Deming regression analysis of ECLIA method comparison to combined LC-MS/MS results yielded a slope of 1.04 [95% confidence interval (CI), 1.03–1.06] and intercept of 2.8 mcg/L (95% CI, 1.5–4.1 mcg/L). Comparison to chemiluminescent microparticle immunoassay yielded a slope of 0.87 (95% CI, 0.85–0.89) and intercept of 1.4 mcg/L (95% CI, −0.89 to 3.7 mcg/L); comparison to antibody-conjugated magnetic immunoassay yielded a slope of 0.96 (95% CI, 0.93–0.98) and intercept of −4.2 mcg/L (95% CI, −7.1 to −1.2 mcg/L).</p></sec><sec><title>Conclusions:</title><p>The data from this multicenter evaluation indicate that the new ECLIA-based cyclosporine assay is fit for its purpose, the therapeutic monitoring of CsA.</p></sec></abstract><kwd-group><title>Key Words:</title><kwd>cyclosporine</kwd><kwd>immunoassay</kwd><kwd>therapeutic drug monitoring</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc><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 Karlsruhe</li><li>District de Stuttgart</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Barcelone</li><li>Bruxelles</li><li>Mannheim</li><li>Munich</li><li>Stuttgart</li></settlement><orgName><li>Université Louis-et-Maximilien de Munich</li></orgName></list><tree><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="Orth, Matthias" sort="Orth, Matthias" uniqKey="Orth M" first="Matthias" last="Orth">Matthias Orth</name><name sortKey="Shipkova, Maria" sort="Shipkova, Maria" uniqKey="Shipkova M" first="Maria" last="Shipkova">Maria Shipkova</name><name sortKey="Widmann, Monika" sort="Widmann, Monika" uniqKey="Widmann M" first="Monika" last="Widmann">Monika Widmann</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="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Wallemacq, Pierre" sort="Wallemacq, Pierre" uniqKey="Wallemacq P" first="Pierre" last="Wallemacq">Pierre Wallemacq</name></region><name sortKey="Verstraete, Alain G" sort="Verstraete, Alain G" uniqKey="Verstraete A" first="Alain G." last="Verstraete">Alain G. 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