生长激素和胰岛素样生长因子I在促生长轴疾病分析中的质量保证

IF 0.1 Q4 OTORHINOLARYNGOLOGY
M. Bidlingmaier, B. Hauffa, P. Trainer, G. Etzrodt-Walter, J. Sauer, J. Kratzsch, S. Petersenn, M. Ranke, H. Wallaschofski, C. Strasburger
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引用次数: 0

摘要

背景:可靠的实验室分析是生长障碍、生长激素(GH)和胰岛素样生长因子I (IGF-I)分泌功能障碍的诊断、治疗和随访的基础。目前可用的商业分析有其局限性,因为它们显示测量的激素浓度变化很大。方法:参照2009年美国维吉尼亚州Keswick跨学科共识会议的成果,采用由儿科和内科内分泌科执业医师和实验室医师组成的专家研讨会的建议。结果:研讨会参与者规定的质量标准包括使用统一的参考标准、分析条件(如校准器、结合表位、交叉反应性和从结合蛋白中去除的方法)的记录、批间一致性和低测定间变异性。与会者建议在大量和定义良好的参考人群的基础上制定分析特定的阈值和参考区间。进一步建议描述分析质量,特别是参考临床重要的截止点。结论:诊断试剂生产企业有义务定期监测和报告质量标准的执行情况。只有根据统一的质量标准进行评估并在临床上使用的检测方法,才能对生长激素分泌功能障碍患者进行知情的诊断和治疗,从而避免给患者和支付当局造成可避免的负担。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality assurance in the analysis of growth hormone and insulin-like growth factor I in disorders of the somatotropic axis
Abstract Background: Reliable laboratory analysis is fundamental to diagnostics, therapy, and follow-up of growth disturbance and secretory dysfunction of growth hormone (GH) and insulin-like growth factor I (IGF-I). Currently available commercial assays have their limitations, as they show large variations in hormone concentrations measured. Methods: The recommendations of an expert workshop with practicing endocrinologists from the fields of pediatrics and internal medicine and with laboratory physicians, with reference to the outcome of the interdisciplinary consensus conference in Keswick (Virginia, USA) in 2009, were used. Results: Among the quality criteria stipulated by the workshop participants are the use of uniform reference standards, documentation of analytical conditions (such as calibrators, binding epitopes, cross-reactivity, and methods for removal from the binding protein), batch-to-batch consistency, and low inter-assay variability. The participants recommended developing assay-specific thresholds and reference intervals based on large and well-defined reference populations. It is furthermore recommended to delineate the assay quality, particularly with reference to clinically important cutoffs. Conclusions: The manufacturers of diagnostic assays should be obliged to regularly monitor and report the implementation of quality criteria. Only assays that are evaluated according to uniform quality standards and that are employed clinically permit informed diagnostic and therapy of patients with GH secretory dysfunction, preventing avoidable burden on both patients and paying authorities.
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CiteScore
0.80
自引率
0.00%
发文量
1
审稿时长
>12 weeks
期刊介绍: Information not localized
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