Gaps in the Traceability Chain of Human Growth Hormone Measurements
| Autor: | Heinz Schimmel, Catharine M. Sturgeon, Katja Hanisch, Sébastien Boulo, Cristian-Gabriel Arsene, Guy Auclair, Martin Bidlingmaier, Mauro Panteghini, Ingrid Zegers |
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| Rok vydání: | 2013 |
| Předmět: |
Immunoassay
Protocol (science) 0303 health sciences Chromatography Traceability Human Growth Hormone Chemistry Human growth hormone 010401 analytical chemistry Biochemistry (medical) Clinical Biochemistry Reference Standards Serum samples 01 natural sciences Mass Spectrometry In vitro diagnostic 0104 chemical sciences 03 medical and health sciences Method comparison External quality assessment Humans Carrier Proteins Chromatography Liquid 030304 developmental biology |
| Zdroj: | Clinical Chemistry. 59:1074-1082 |
| ISSN: | 1530-8561 0009-9147 |
| Popis: | 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 (Off J Eur Communities 1998 Dec 7;L 331:1–37). 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. |
| Databáze: | OpenAIRE |
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