Gaps in the Traceability Chain of Human Growth Hormone Measurements | Zendy

Sébastien Boulo | Zendy; Katja Hanisch | Zendy; Martin Bidlingmaier | Zendy; Cristian Arsene | Zendy; Mauro Panteghini | Zendy; Guy Auclair | Zendy; Catharine M. Sturgeon | Zendy; Heinz Schimmel | Zendy; Ingrid Zegers | Zendy

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Gaps in the Traceability Chain of Human Growth Hormone Measurements

Author(s) -

Sébastien Boulo,

Katja Hanisch,

Martin Bidlingmaier,

Cristian Arsene,

Mauro Panteghini,

Guy Auclair,

Catharine M. Sturgeon,

Heinz Schimmel,

Ingrid Zegers

Publication year - 2013

Publication title -

clinical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.705

H-Index - 218

eISSN - 1530-8561

pISSN - 0009-9147

DOI - 10.1373/clinchem.2012.199489

Subject(s) - traceability , external quality assessment , immunoassay , matrix (chemical analysis) , chromatography , growth hormone , chemistry , medicine , hormone , statistics , mathematics , immunology , pathology , antibody

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.

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