• Treffer 3 von 24
Zurück zur Trefferliste

Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material

  • Hepcidin-25 concentrations measured by various methods differ considerably, complicating interpretation. Here, a previously identified plasma-based candidate secondary reference material (csRM) was modified into a serum-based two-leveled sRM. We validated its functionality to increase the equivalence between methods for international standardization. We applied technical procedures developed by the International Consortium for Harmonization of Clinical Laboratory Results. The sRM, consisting of lyophilized serum with cryolyoprotectant, appeared commutable among nine different measurement procedures using 16 native human serum samples in a first round robin (RR1). Harmonization potential of the sRM was simulated in RR1 and evaluated in practice in RR2 among 11 measurement procedures using three native human plasma samples. Comprehensive purity analysis of a candidate primary RM (cpRM) was performed by state-of-the-art procedures. The sRM was value assigned with an isotope dilution massHepcidin-25 concentrations measured by various methods differ considerably, complicating interpretation. Here, a previously identified plasma-based candidate secondary reference material (csRM) was modified into a serum-based two-leveled sRM. We validated its functionality to increase the equivalence between methods for international standardization. We applied technical procedures developed by the International Consortium for Harmonization of Clinical Laboratory Results. The sRM, consisting of lyophilized serum with cryolyoprotectant, appeared commutable among nine different measurement procedures using 16 native human serum samples in a first round robin (RR1). Harmonization potential of the sRM was simulated in RR1 and evaluated in practice in RR2 among 11 measurement procedures using three native human plasma samples. Comprehensive purity analysis of a candidate primary RM (cpRM) was performed by state-of-the-art procedures. The sRM was value assigned with an isotope dilution mass spectrometry-based candidate reference method calibrated using the certified pRM. The inter-assay CV without harmonization was 42.1% and 52.8% in RR1 and RR2, respectively. In RR1, simulation of harmonization with sRM resulted in an inter-assay CV of 11.0%, whereas in RR2 calibration with the material resulted in an inter-assay CV of 19.1%. Both the sRM and pRM passed international homogeneity criteria and showed long-term stability. We assigned values to the low (0.95 ± 0.11 nmol/L) and middle concentration (3.75 ± 0.17 nmol/L) calibrators of the sRM. Standardization of hepcidin is possible with our sRM, which value is assigned by a pRM. We propose the implementation of this material as an international calibrator for hepcidin-25.zeige mehrzeige weniger

Volltext Dateien herunterladen

  • Diepeveen-2018-ClinChemLabMed.pdf
    eng

Metadaten exportieren

Weitere Dienste

Teilen auf Twitter Suche bei Google Scholar Anzahl der Zugriffe auf dieses Dokument
Metadaten
Autor*innen:L. E. Diepeveen, C. M. M. Laarakkers, G. Martos, M. E. Pawlak, F. F. Uguz, K. E. S. A. Verbene, R. P. L. van Swelm, S. Klaver, A. F. J. de Haan, K. R. Pitts, S. S. Bansal, Ioana M. AbbasORCiD, M. Fillet, T. Lefebvre, A. J. Geurts-Moespot, D. Girelli, A. Castagna, M. Herkert, O. Itkonen, G. Olbina, N. Tomosugi, M. E. Westerman, V. Delatour, C. W. Weykamp, D. W. Swinkels
Dokumenttyp:Zeitschriftenartikel
Veröffentlichungsform:Verlagsliteratur
Sprache:Englisch
Titel des übergeordneten Werkes (Englisch):Clinical Chemistry and Laboratory Medicine (CCLM)
Jahr der Erstveröffentlichung:2018
Organisationseinheit der BAM:1 Analytische Chemie; Referenzmaterialien
1 Analytische Chemie; Referenzmaterialien / 1.5 Proteinanalytik
Verlag:De Gruyter
Verlagsort:Berlin
Jahrgang/Band:57
Ausgabe/Heft:6
Erste Seite:864
Letzte Seite:872
DDC-Klassifikation:Naturwissenschaften und Mathematik / Chemie / Analytische Chemie
Freie Schlagwörter:Bioanalysis; Biomarker; ELISA; Immunoassay; Iron deficiency; LC-MS/MS; MALDI-TOF MS; Mass spectrometry; Peptide; Reference material; UHPLC-MS/MS
Themenfelder/Aktivitätsfelder der BAM:Chemie und Prozesstechnik
DOI:10.1515/cclm-2018-0783
ISSN:1437-4331
ISSN:1434-6621
Verfügbarkeit des Dokuments:Datei im Netzwerk der BAM verfügbar ("Closed Access")
Datum der Freischaltung:08.01.2019
Referierte Publikation:Ja
Datum der Eintragung als referierte Publikation:23.05.2019
Einverstanden
Diese Webseite verwendet technisch erforderliche Session-Cookies. Durch die weitere Nutzung der Webseite stimmen Sie diesem zu. Unsere Datenschutzerklärung finden Sie hier.