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Submitted on September 17, 2007
Accepted on December 21, 2007
Department of Endocrinology, Diabetes and Nutrition, Charité-University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany, and the Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; Department of Clinical Chemistry and Pathobiochemistry, Charité-University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany; Department of Clinical Endocrinology, Charité-University Medicine Berlin, Campus Mitte, Berlin, Germany; Division of Neuroendocrinology, Department of Neurosurgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany
* To whom correspondence should be addressed. E-mail: ayman.arafat{at}charite.de.
Context: Besides the measurement of IGF-I, GH suppression during OGTT is recommended to assess the biochemical status in acromegaly. The development of highly sensitive and specific GH assays, however, necessitates a critical reevaluation of criteria for diagnosis and follow-up of disease activity.
Objective: To evaluate the between-method discrepancies in GH determinations by different immunoassays considering further confounders like age, gender, and BMI.
Design, Subjects, and Methods: We measured GH during 75-g OGTT in 46 acromegaly patients (18 controlled, 28 uncontrolled; 19 men; 31–63 yr; BMI 26.4 ± 0.4 kg/m2) and in 213 healthy subjects (66 men; 20–76; BMI 30 ± 0.5), using three different commercially available assays (Immulite, Nichols, and DSL) that were calibrated against the recently recommended GH standards.
Results: Results from all assays strongly correlated (r = 0.8–0.996, P < 0.0001). However, the results obtained with the Immulite-assay were, on average, 2.3-fold higher than those obtained with Nichols and 6-fold higher than those obtained with DSL. Using cutoff limits of 1 µg/liter (Immulite) and 0.5 µg/liter (Nichols) identified 95% of patients with active disease and 78–80% of patients in remission. Basal and nadir GH levels were significantly higher in females than in males [Immulite (µg/liter): 2.2 ± 0.28 vs. 0.73 ± 0.15, and 0.16 ± 0.01 vs. 0.08 ± 0.01, P < 0.001, respectively]. In multiple regression analysis, age, BMI, and gender were predictors for basal and nadir GH levels.
Conclusions: Post-glucose GH-nadir values are assay-, gender-, age-, and BMI-specific, indicating the need of individual cutoff limits for each assay.
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