Reference intervals for insulin-like growth factor-1 (igf-i) from birth to senescence: results from a multicenter study using a new automated chemiluminescence IGF-I immunoassay conforming to recent international recommendations
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. Our objectives were develo...
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| Published in: | The journal of clinical endocrinology and metabolism Vol. 99; no. 5; p. 1712 |
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| Main Authors: | , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01.05.2014
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| Subjects: | |
| ISSN: | 1945-7197, 1945-7197 |
| Online Access: | Get more information |
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| Abstract | 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.
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.
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).
We measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay.
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.
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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| AbstractList | 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.
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.
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).
We measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay.
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.
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. 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.CONTEXTMeasurement 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.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.OBJECTIVESOur 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.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).SETTING AND PARTICIPANTSWe 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).We measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay.MAIN OUTCOME MEASURESWe measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay.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.RESULTSA 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.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.CONCLUSIONSUsing 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. |
| Author | Bidlingmaier, Martin Spranger, Joachim Körner, Antje Wolthers, Ole D Dahlgren, Jovanna Frystyk, Jan Arafat, Ayman M Hübener, Christoph Obermayer-Pietsch, Barbara Friedrich, Nele Bielohuby, Maximilian Doering, Angela Emeny, Rebecca T Roswall, Josefine Pfeiffer, Andreas F H Wallaschofski, Henri |
| Author_xml | – sequence: 1 givenname: Martin surname: Bidlingmaier fullname: Bidlingmaier, Martin organization: Endocrine Research Laboratories (M.Bid., M.Bie.), Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, 80336 Munich, Germany; Metabolic Center (N.F., H.W.), Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, 17475 Greifswald, Germany; Helmholtz Zentrum München-German Research Center for Environmental Health (GmbH) (R.T.E., A.D.), Institute of Epidemiology II, 85764 Neuherberg, Germany; Department of Endocrinology, Diabetes, and Nutrition (J.S., A.F.H.P., A.M.A.), Charité-University Medicine Berlin, 10117 Berlin, Germany; Experimental and Clinical Research Center (J.S.), Charité-University Medicine Berlin and Max-Delbrück Centre Berlin-Buch, 13125 Berlin, Germany; Center for Cardiovascular Research (J.S., A.M.A.), Charité-University Medicine Berlin, 10115 Berlin, Germany; Children's Clinic Randers (O.D.W.), DK-8900 Randers, Denmark; Göteborg Pediatric Growth Research Center (J.R.), The Sahlgrenska Academy at University of Gothenburg, 41685 Gothenburg, Sweden; Center for Pediatric Research (A.K.), Hospital for Children and Adolescents, Department of Women's and Child Health, University of Leipzig, 04103 Leipzig, Germany; Klinische Abteilung und Labor für Endokrinologie und Stoffwechsel (B.O.-P.), Universitätsklinik für Innere Medizin, Medizinische Universität Graz, 8036 Graz, Austria; Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe-Grosshadern (C.H.), Klinikum der Universität München, 81377 Munich, Germany; Medical Research Laboratory (J.F.), Department of Clinical Medicine, Faculty of Health, Aarhus University, DK-8000 Aarhus, Denmark; Department of Endocrinology and Internal Medicine (J.F.), Aarhus University Hospital, DK-8000 Aarhus, Denmark; and Department of Clinical Nutrition (A.F.H.P., A.M.A.), German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany – sequence: 2 givenname: Nele surname: Friedrich fullname: Friedrich, Nele – sequence: 3 givenname: Rebecca T surname: Emeny fullname: Emeny, Rebecca T – sequence: 4 givenname: Joachim surname: Spranger fullname: Spranger, Joachim – sequence: 5 givenname: Ole D surname: Wolthers fullname: Wolthers, Ole D – sequence: 6 givenname: Josefine surname: Roswall fullname: Roswall, Josefine – sequence: 7 givenname: Antje surname: Körner fullname: Körner, Antje – sequence: 8 givenname: Barbara surname: Obermayer-Pietsch fullname: Obermayer-Pietsch, Barbara – sequence: 9 givenname: Christoph surname: Hübener fullname: Hübener, Christoph – sequence: 10 givenname: Jovanna surname: Dahlgren fullname: Dahlgren, Jovanna – sequence: 11 givenname: Jan surname: Frystyk fullname: Frystyk, Jan – sequence: 12 givenname: Andreas F H surname: Pfeiffer fullname: Pfeiffer, Andreas F H – sequence: 13 givenname: Angela surname: Doering fullname: Doering, Angela – sequence: 14 givenname: Maximilian surname: Bielohuby fullname: Bielohuby, Maximilian – sequence: 15 givenname: Henri surname: Wallaschofski fullname: Wallaschofski, Henri – sequence: 16 givenname: Ayman M surname: Arafat fullname: Arafat, Ayman M |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24606072$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
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| DOI | 10.1210/jc.2013-3059 |
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| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 1945-7197 |
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| PublicationTitle | The journal of clinical endocrinology and metabolism |
| PublicationTitleAlternate | J Clin Endocrinol Metab |
| PublicationYear | 2014 |
| References | 32927474 - J Clin Endocrinol Metab. 2020 Dec 1;105(12) |
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| Snippet | Measurement of IGF-I is a cornerstone in diagnosis and monitoring of GH-related diseases, but considerable discrepancies exist between analytical methods. A... |
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| SubjectTerms | Adolescent Adult Aged Aged, 80 and over Aging - blood Child Child, Preschool Female Humans Immunoassay - methods Infant Infant, Newborn Insulin-Like Growth Factor I - analysis Insulin-Like Growth Factor I - metabolism Luminescent Measurements - methods Male Middle Aged Reference Values |
| Title | Reference intervals for insulin-like growth factor-1 (igf-i) from birth to senescence: results from a multicenter study using a new automated chemiluminescence IGF-I immunoassay conforming to recent international recommendations |
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