| Zugriffsnummer | 28993 |
| Dokumenttyp | Zeitschriftenartikel |
| Sprache | Englisch |
| Titel | Gaps in the traceability chain of human growth hormone measurements. |
| Autor(in); Institution |
Boulo, Sébastien; Insitute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, BELGIUM
Hanisch, Katja; Insitute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, BELGIUM
Bidlingmaier, Martin; Universität München, Endocrine Laboratory, Medizinische Klinik und Poliklinik IV, München, GERMANY
Arsene, Cristian-Gabriel; 3.1, Metrologie in der Chemie, PTB-Braunschweig
Panteghini, Mauro; University of Milan, Centre for Metrological Traceability in Laboratory Medicine, Milan, ITALY
Auclair, Guy; Insitute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, BELGIUM
Sturgeon, Catharine; External Quality Assessment Service (NEQAS), Department of Laboratory Medicine, Royal Infirmary, Edingburgh, UK
Schimmel, Heinz; Insitute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, BELGIUM
Zegers, Ingrid; Insitute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, BELGIUM
|
| Quelle/Jahr | Clinical Chemistry: 59 (2013), 7, 1074 - 1082 |
| ISSN | 0009-9147 (PRINT) ; 1530-8561 (ONLINE) |
| DOI | |
| Verlag | Washington, DC: American Association for Clinical Chemistry |
| Zusammenfassung | Background: Human growth hormone (hGH) is measured for the diagnosis of secretion disorders. These measurements fall under the EU Directive 98/79/EC on in vitro diagnostic medical devices requiring traceability of commercial calibrator values to higher-order reference materials or procedures. External quality assessment schemes show large discrepancies between results from different methods, even though most methods provide results traceable to the recommended International Standard (IS 98/574). The aim of this study was to investigate possible causes for these discrepancies. Methods: We investigated the commutability and recovery of hGH in reconstituted IS 98/574. We tested different reconstitution protocols and used 4 different serum matrices for spiking. These IS preparations were measured together with serum samples. We quantified hGH by 5 different methods in 4 different laboratories. Results: Results from the different methods correlated well for the serum samples. Mean discrepancies between results from different methods were ≤20%. None of the IS preparations was commutable for all the method comparisons. The recovery of hGH in preparations of IS 98/574 depended on the reconstitution protocol ()10-fold differences) and background matrix (relative differences ≤17% for different serum matrices). Conclusions: The use of different protocols for reconstitution and spiking of hGH reference preparations affects quantification by immunoassays, potentially leading to a bias between commercial methods, despite the use of calibrators with values claimed to be traceable to the same higher-order reference material. |
Zitierung
Boulo, S., Hanisch, K., Bidlingmaier, M., Arsene, C.-G., Panteghini, M., Auclair, G., Sturgeon, C., Schimmel, H., & Zegers, I. (2013). Gaps in the traceability chain of human growth hormone measurements. Clinical Chemistry, 59(7), 1074–1082. https://doi.org/10.1373/clinchem.2012.199489