Gaps in the traceability chain of human growth hormone measurements

Clinical Chemistry

Volumn 59, Issue 7, 2013, Pages 1074-1082

  Boulo, Sébastien ^a   Hanisch, Katja ^a   Bidlingmaier, Martin ^b   Arsene, Cristian Gabriel ^c   Panteghini, Mauro ^d   Auclair, Guy ^a   Sturgeon, Catharine ^e   Schimmel, Heinz ^a   Zegers, Ingrid ^a  

^a JOINT RESEARCH CENTRE   (Italy)

^b LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^c PHYSIKALISCH TECHNISCHE BUNDESANSTALT   (Germany)

^d UNIVERSITY OF MILAN   (Italy)

^e ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN GROWTH HORMONE;

ARTICLE; CONTROLLED STUDY; CORRELATION ANALYSIS; GROWTH HORMONE BLOOD LEVEL; HUMAN; INTERMETHOD COMPARISON; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; QUANTITATIVE ANALYSIS; SERUM;

CARRIER PROTEINS; CHROMATOGRAPHY, LIQUID; HUMAN GROWTH HORMONE; HUMANS; IMMUNOASSAY; MASS SPECTROMETRY; REFERENCE STANDARDS;

EID: 84879712593     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2012.199489     Document Type: Article

References (25)

1. Markkanen H, Pekkarinen T, Valimaki MJ, Alfthan H, Kauppinen-Makelin R, Sane T, Stenman UH. Effect of sex and assay method on serum concentrations of growth hormone in patients with acromegaly and in healthy controls. Clin Chem 2006;52:468-73.
2. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. J Clin Endocrinol Metab 2000;83:3990-3.
3. Assessment and long-term monitoring in patients with acromegaly: statement from a joint consensus conference of the Growth Hormone Research Society and the Pituitary Society. J Clin Endocrinol Metab 2004;89:3099-102.
4. Popii V, Baumann G. Laboratory measurement of growth hormone. Clin Chim Acta 2004;350:1-16. (Pubitemid 39458242)
5. Strasburger CJ, Bidlingmaier M. How robust are laboratory measures of growth hormone status? Horm Res 2005;64 Suppl 2:1-5. (Pubitemid 41665849)
6. Tong J, D'Alessio D, Ramisch J, Davis HW, Stambrook E, Tschop MH, Bidlingmaier M. Ghrelin stimulation of growth hormone isoforms: parallel secretion of total and 20-kDa growth hormone and relation to insulin sensitivity in healthy humans. J Clin Endocrinol Metab 2012;97:3366-74.
7. Trainer PJ, Barth J, Sturgeon C, Wieringaon G. Consensus statement on the standardisation of GH assays. Eur J Endocrinol 2006;155:1-2. (Pubitemid 44103367)
8. Bidlingmaier M, Freda PU. Measurement of human growth hormone by immunoassays: current status, unsolved problems and clinical consequences. Growth Horm IGF Res 2010;20:19-25.
9. De Palo EF, De Filippis V, Gatti R, Spinella P. Growth hormone isoforms and segments/fragments: molecular structure and laboratory measurement. Clin Chim Acta 2006;364:67-76. (Pubitemid 43124017)
10. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Off J Eur Communities 1998 Dec 7;L 331:1-37. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri-CELEX: 31998L0079:20090807:EN:HTML (Accessed June 2013).
11. Clemmons DR. Consensus statement on the standardization and evaluation of growth hormone and insulin-like growth factor assays. Clin Chem 2011;57:555-9.
12. Bristow AF, Jespersen AM. The Second International Standard for somatropin (recombinant DNA-derived human growth hormone): preparation and calibration in an international collaborative study. Biologicals 2001;29:97-106. (Pubitemid 32977038)
13. Pritchard C, Quaglia M, Mussell C, Burkitt WI, Parkes H, O'Connor G. Fully traceable absolute protein quantification of somatropin that allows independent comparison of somatropin standards. Clin Chem 2009;55:1984-90.
14. RfB: Referenzinstitut für Bioanalytik. Ringversuche/HP - Hormonbestimmungen Gruppe 2/2009/Serum 2009. http://www.dgkl-rfb.de (Accessed March 2013).
15. CLSI. Characterization and qualification of commutable reference materials for laboratory medicine; approved guideline. Wayne (PA): CLSI; 2010. Document no. C53-A.
16. WHO International Standard: somatrophin (recombinant DNA-derived human growth hormone): NIBSC code: 98/574: instructions for use (version 4.0, dated 14/01/2008). Potters Bar (UK): National Institute for Biological Standards and Control; 2012. http://www.nibsc.ac.uk/ (Accessed June 2013).
17. ASTM D4052 - 11: ASTM D4052 - 11 standard test method for density, relative density, and API gravity of liquids by digital density meter. 2011. http://www.astm.org/Standards/D4052 (Accessed June 2013).
18. Zegers I, Schreiber W, Sheldon J, Blirup-Jensen S, Muñoz A, Merlini G, et al. Certification of proteins in the human serum: Certified Reference Material ERM®- DA470k/IFCC. Luxembourg: Office for Official Publications of the European Communities; 2008. http://publications.jrc.ec.europa.eu/repository/ handle/111111111/12304 (Accessed June 2013). Identifier: EUR 23431 EN.
19. R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing: 2012. http://www.R-project.org (Accessed March 2013).
20. Arsene CG, Henrion A, Diekmann N, Manolopoulou J, Bidlingmaier M. Quantification of growth hormone in serum by isotope dilution mass spectrometry. Anal Biochem 2010;401:228-35.
21. Manolopoulou J, Alami Y, Petersenn S, Schopohl J, Wu Z, Strasburger CJ, Bidlingmaier M. Automated 22-kD growth hormone-specific assay without interference from pegvisomant. Clin Chem 2012;58:1446-56.
22. Muller A, Scholz M, Blankenstein O, Binder G, Pfaffle R, Korner A, et al. Harmonization of growth hormone measurements with different immunoassays by data adjustment. Clin Chem Lab Med 2011;49:1135-42.
23. Ross HA. Reporting growth hormone assay results in terms of one consensus recombinant standard preparation offers less than optimal reduction of between-method variation. Clin Chem Lab Med 2008;46:1334-5.
24. Ross HA, Lentjes E, Menheere PP. The consensus statement on the standardization and evaluation of growth hormone and insulin-like growth factor assays lacks a recommendation to attempt efficacious harmonization. Clin Chem 2011;57:1463, author reply 1464.
25. Hansen TK, Fisker S, Hansen B, Sorensen HH, Christiansen JS, Jorgensen JO, H OR. Impact of GHBP interference on estimates of GH and GH pharmacokinetics. Clin Endocrinol 2002;57:779-86. (Pubitemid 36963006)