| Zugriffsnummer | 31320 |
| Dokumenttyp | Zeitschriftenartikel |
| Sprache | Englisch |
| Titel | Clinical evidence based decision limits for growth hormone stimulation tests in children with back-up of results by reference to mass spectrometry. |
| Autor(in); Institution |
Wagner, Isabel Viona; University of Leipzig, Centre for Paediatric Research Leipzig (CPL), Leipzig, GERMANY
Petzold, Claudia; University of Leipzig, Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, Leipzig, GERMANY
Gausche, Ruth; University of Leipzig, CrescNet GmbH, Leipzig, GERMANY
Vogel, Mandy; University of Leipzig, CrescNet GmbH, Leipzig, GERMANY
Körner, Antje; University of Leipzig, Centre for Paediatric Research Leipzig (CPL), Leipzig, GERMANY
Thiery, Joachim; University of Leipzig, Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, Leipzig, GERMANY
Arsene, Cristian-Gabriel; 3.1, Metrologie in der Chemie, PTB-Braunschweig
Henrion, André; 3.1, Metrologie in der Chemie, PTB-Braunschweig
Güttler, Bernd; 3.1, Metrologie in der Chemie, PTB-Braunschweig
Keller, Eberhard; University of Leipzig, Centre for Paediatric Research Leipzig (CPL), Leipzig, GERMANY
Kiess, Wieland; University of Leipzig, Centre for Paediatric Research Leipzig (CPL), Leipzig, GERMANY
Pfäffle, Roland; University of Leipzig, Centre for Paediatric Research Leipzig (CPL), Leipzig, GERMANY
Kratzsch, Jürgen; University of Leipzig, Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, Leipzig, GERMANY
|
| Quelle/Jahr | European Journal of Endocrinology: 171 (2014), 389 - 397 |
| ISSN | 0804-4643 (PRINT) ; 1479-683X (ONLINE) |
| DOI | |
| Verlag | Bristol: BioScientifica |
| Freie Schlagworte | GH ; cut-off limit ; iSYS ; mass spectrometry ; stability of GH ; stimulation tests in children |
| Zusammenfassung | Background: Currently cut-off limits for GH-stimulation tests in children are not validated by clinical studies. In addition, GH concentrations are not referenced to antibody-independent methods like mass spectrometry which function as gold standard to backup laboratory results. Methods: Stored sera of 52 children and adolescents with short stature that showed adequate GH secretion in a GH stimulation test were included in a retrospective study. This cohort was used to establish a new decision limit specific for the iSYS assay and compared to the results of 44 patients with GHD. Using transformation factors the iSYS specific cut-off value was extrapolated to 7 hGH assays of other manufacturers. Additionally, for a subset of patient sera, tryptic cleavage fragments of GH representative for “22k GH” and “total GH” were quantified by isotope dilution mass spectrometry (ID-MS) for the calculation of cut-off concentrations. Results: hGH concentration of sera stored at -80° ± 5° C were stable for at least 10 years. Discriminant analysis of re-measured GH concentrations from stored non-GHD and GHD patient sera led to a new cut-off limit of 7.09 ng/mL, the limits for the other 7 hGH assays varied between 4.32 ng/mL and 7.77 ng/mL. For ID-MS cut-offs of 5.48 ng/mL (22k GH) and 7.43 ng/mL (total GH) were ascertained. Conclusions: The establishment of method-specific clinical evidence-based GH cut-off concentrations is of importance to encure adequate clinical diagnosis and treatment of children and adolescents with GHD. ID-MS is an important tool for providing both reliable and sustainable SI traceability of GH measurements. |
Zitierung
Wagner, I. V., Petzold, C., Gausche, R., Vogel, M., Körner, A., Thiery, J., Arsene, C.-G., Henrion, A., Güttler, B., Keller, E., Kiess, W., Pfäffle, R., & Kratzsch, J. (2014). Clinical evidence based decision limits for growth hormone stimulation tests in children with back-up of results by reference to mass spectrometry. European Journal of Endocrinology, 171, 389–397. https://doi.org/10.1530/eje-14-0165