Monogioudi Evanthia, Zegers Ingrid
European Commission, Joint Research Centre (JRC), Geel, Belgium.
Mediterr J Rheumatol. 2019 Mar 28;30(1):26-32. doi: 10.31138/mjr.30.1.26. eCollection 2019 Mar.
Autoantibody measurement is the chosen tool, in addition to clinical observations, for the diagnosis of autoimmune diseases. Hence, it is essential for these measurements to be reliable and in the longer run to be standardised. Due to the intrinsic variability of analytes and reagents, and the heterogeneity of the available techniques, standardisation cannot be taken for granted, and results may vary between laboratories. As a consequence, diagnoses can be missed or wrong and unnecessary costs may burden individuals and healthcare systems. Standardisation of autoantibody testing is a demanding and multi-parameter task, but could be part of the solution. So as to achieve standardisation, the development and availability of suitable certified reference materials for calibration and/or quality control is crucial.
除临床观察外，自身抗体检测是诊断自身免疫性疾病的首选工具。因此，这些检测结果必须可靠且长期实现标准化，这至关重要。由于分析物和试剂的内在变异性以及现有技术的异质性，标准化并非理所当然，不同实验室的结果可能会有所不同。因此，可能会漏诊或误诊，个人和医疗保健系统可能会承担不必要的费用。自身抗体检测的标准化是一项艰巨且多参数的任务，但可能是解决方案的一部分。为了实现标准化，开发和提供适用于校准和/或质量控制的经认证的参考物质至关重要。
