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CONSENSUS STATEMENT |
1 Department of Endocrinology and 2 Biochemistry, Christie Hospital, Wilmslow Road, Manchester, M20 4BX, UK, 3 Department of Clinical Biochemistry and Immunology, Leeds General Infirmary, Leeds, UK and 4 United Kingdom National External Quality Assessment Scheme, Department of Biochemistry, Royal Infirmary, 51 Little Frank Crescent, Edinburgh EH16 4SA, UK
(Correspondence should be addressed to P J Trainer; Email: peter.trainer{at}man.ac.uk)
Consensus statement from an international collaborative
The availability of calibrants with different characteristics, the use of two units (mU/l and µg/l), adoption of a variety of unit conversion factors, and variability in antibody specificity are widely acknowledged as contributing to discrepancies between growth hormone (GH) results (1, 2). The discrepancies cause confusion and can have serious implications for the management of patients with GH-related disorders whose care is increasingly dependent on consensus guidelines employing mass concentration (3, 4) National Institute of Clinical Excellence guidelines 2003. The availability of the second International Standard (IS) for GH (WHO IS 98/574), a recombinant material consisting of 22 kDa GH of more than 95% purity, provides the opportunity for adoption of a single calibrant for GH immunoassays (5). IS 98/574s well-defined chemical and physical properties allow it to meet European Union legislation calls for all laboratory results to be traceable to a defined material (In vitro Diagnostics Medical Devices Directive, 98/79/EC). As a first step to standardising GH measurement, we recommend the reporting of GH concentrations in micrograms per litre (µg/l) of IS 98/574 (1 mg corresponding to three international units somatropin). A later step will be to reduce the discrepancy in results attributable to variable antibody specificity.
Collaborative membership
The consensus statement represents the input of its members as follows:
Association for Clinical Biochemistry, 130132 Tooley Street, London, SE1 2TU, UK
British In vitro Diagnostics Association, 1 Queen Annes Gate, London, SW1H 9BT, UK
National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK
Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, UK
Royal College of Pathologists, 2 Carlton House Terrace, London, SW1Y 5AF, UK
Society for Endocrinology, 22 Apex Court, Woodlands, Bradley Stoke, Bristol, BS32 4JT, UK
UK National External Quality Assessment Service, PO Box 401, Sheffield, S5 7YZ, UK
Acknowledgements
We are grateful for the advice, guidance and support provided by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC). We are also grateful to the diagnostics industry for their support during the development of the consensus statement, as follows: Beckman Coulter, Inc.
Clinical Diagnostics Division, 1000 Lake Heseltine Dr, Chaska, MN 55 318-1084, USA
BioSource Europe SA, Invitrogen Endocrinology Assays, Invitrogen Corporation, Rue de lIndustrie, 8, B-1400 Nivelles, Belgium
PerkinElmer Life and Analytical Sciences/Wallac Oy, PO Box 10, FIN-20 101, Turku, Finland
TOSOH Bioscience, Inc., 6000 Shoreline Court, Suite 101, South San Francisco, CA 94 080, USA
This statement ia also published in Clinical Endocrinology and Growth Hormone and IGF Research. Copyright remains with the authors.
Footnotes
The European Journal of Endocrinology starting from January 1 2007 will publish papers on GH data only if expressed in mass units of IS 98 574.
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