期刊
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
卷 99, 期 5, 页码 1712-1721出版社
ENDOCRINE SOC
DOI: 10.1210/jc.2013-3059
关键词
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资金
- Clinical Institute, Health, Aarhus University
- Johannes M. Klein og Hustrus Mindelegat
- Forskningsfonden Laegekredsforeningen for Aarhus Amt
- Kong Christian den Tiendes Fond
- Overlaege Johan Boserup og Lise Boserups Legat
- Koventualinde Emilie De Lancy's Fond
- German Federal Ministry of Education and Research [FKZ 01ET1003D, BMBF 0313042]
- Federal Ministry of Education and Research
- Ministry of Cultural Affairs of the Federal State of Mecklenburg-West Pomerania [03IS2061A]
- Community Medicine Research Network (CMR) of the University of Greifswald, Germany
- Ministry of Cultural Affairs
- Social Ministry of the Federal State of Mecklenburg-West Pomerania
- GSF-National Research Center for Environment and Health, Neuherberg, Germany
- German Federal Ministry of Education, Science, Research, and Technology
- State of Bavaria
- German Research Foundation (DFG) [GK1208]
- BioPersMed(COMETK) [825329]
- Austrian Federal Ministry of Transport, Innovation, and Technology (BMVIT)
- Austrian Federal Ministry of Economics and Labor
- Federal Ministry of Economy, Family, and Youth
- Styrian Business Promotion Agency
- LIFE (Leipzig Research Center for Civilization Diseases, Universitat Leipzig)
- European Union
- European Regional Development Fund (ERFD)
- Research and Development Board
- Halland County Council
- Halland Regional Development Council
- IDS
- Siemens
- Novartis
- Pfizer
- Chiasma
- Prolor
Context: Measurement of IGF-I is a cornerstone in diagnosis and monitoring of GH-related diseases, but considerable discrepancies exist between analytical methods. A recent consensus conference defined criteria for validation of IGF-I assays and for establishment of normative data. Objectives: Our objectives were development and validation of a novel automated IGF-I immunoassay (iSYS; Immunodiagnostic Systems) according to international guidelines and establishment of method-specific age- and sex-adjusted reference intervals and analysis of their robustness. Setting and Participants: We conducted a multicenter study with samples from 12 cohorts from the United States, Canada, and Europe including 15 014 subjects (6697 males and 8317 females, 0-94 years of age). Main Outcome Measures: We measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay. Results: A new IGF-I assay calibrated against the recommended standard (02/254) and insensitive to the 6 high-affinity IGF binding proteins was developed and rigorously validated. Age- and sex-adjusted reference intervals derived from a uniquely large cohort reflect the age-related pattern of IGF-I secretion: a decline immediately after birth followed by an increase until a pubertal peak (at 15 years of age). Later in life, values decrease continuously. The impact of gender is small, although across the lifespan, women have lower mean IGF-I concentrations. Geographical region, sampling setting (community or hospital based), and rigor of exclusion criteria in our large cohort did not affect the reference intervals. Conclusions: Using large cohorts of well-characterized subjects from different centers allowed construction of robust reference ranges for a new automated IGF-I assay. The strict adherence to recent consensus criteria for IGF-I assays might facilitate clinical application of the results.
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