从出生到衰老的胰岛素样生长因子-1（IGF-1）参考区间：使用符合最近国际建议的新型自动化化学发光 IGF-I 免疫分析法进行的多中心研究结果。

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.

机构信息

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.

出版信息

J Clin Endocrinol Metab. 2014 May;99(5):1712-21. doi: 10.1210/jc.2013-3059. Epub 2014 Feb 27.

DOI:10.1210/jc.2013-3059

PMID:24606072

Abstract

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.

摘要

背景

IGF-I 的测量是诊断和监测与 GH 相关疾病的基石，但分析方法之间存在相当大的差异。最近的一次共识会议定义了 IGF-I 检测的验证标准和规范数据的建立标准。

目的

根据国际指南，我们的目标是开发和验证一种新型自动化 IGF-I 免疫分析（iSYS；免疫诊断系统），并建立特定方法的年龄和性别调整参考区间，并分析其稳健性。

设置和参与者

我们进行了一项多中心研究，样本来自美国、加拿大和欧洲的 12 个队列，包括 15014 名受试者（6697 名男性和 8317 名女性，0-94 岁）。

主要观察指标

我们测量了由 IDS iSYS IGF-I 测定法确定的 IGF-I 浓度。

结果

开发并严格验证了一种新的 IGF-I 测定法，该方法针对推荐的标准（02/254）进行校准，并且对 6 种高亲和力 IGF 结合蛋白不敏感。从一个独特的大队列中得出的年龄和性别调整参考区间反映了 IGF-I 分泌的年龄相关模式：出生后立即下降，然后增加，直到青春期高峰（15 岁）。在生命的后期，数值持续下降。性别的影响很小，尽管在整个生命周期中，女性的 IGF-I 浓度较低。在我们的大队列中，地理位置、采样环境（社区或医院）和严格的排除标准并没有影响参考区间。