Standardization of the IMMULITE systems growth hormone assay with the recombinant IS 98/574

This version was published on 1 November 2008

Ann Clin Biochem 2008;45:598-600
© 2008 Association for Clinical Biochemistry


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Short Reports

Julian H Barth1 and
Paul E C Sibley2

1 Department of Clinical Biochemistry and Immunology, Leeds General Infirmary, Leeds LS1 3EX;
2 Siemens Healthcare Diagnostics, Glyn Rhonwy, Llanberis LL55 4EL, UK

Corresponding author: Dr Julian H Barth. Email: julian.barth{at}

Background: The diagnosis of disorders of growth hormone (GH) secretionis based on the measurement of GH before and after dynamic stimulationor suppression tests. Over the years, specific cut-off valueshave been proposed without taking account of the considerablevariation in results obtained using different methods for analysingGH. Recent publications have recommended the standardizationof GH assays using IS 98/574, which is calibrated in mass andunits (U). The IMMULITE range of GH assays have been recalibratedusing this standard.

Methods: We analysed 745 samples using the current and the restandardizedGH assay kits. This series of samples contained 90 stimulationtests and seven suppression tests.

Results: The data comparing the current and restandardized assays show a similar relationship for both basal and stimulated GH values for all IMMULITE platforms. There is a negative bias by the restandardized assay above approximately 20 µg/L. A conversioncan be derived from this study which would mean that patientGH results expressed in milliunits per litre of IMMULITE in-housederived standard will be approximately three-fold of that expressedin micrograms per litre of IS 98/574.

Conclusion: Use of IS 98/574 offers standardized reporting in microgramper litre IS 98/574. This will permit compliance with the consensusrecommendations and the development of a firm evidence basefor defining decision-making GH values.

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