Sack Ulrich, Bossuyt Xavier, Andreeva Hristina, Antal-Szalmás Péter, Bizzaro Nicola, Bogdanos Dimitrios, Borzova Elena, Conrad Karsten, Dragon-Durey Marie-Agnes, Eriksson Catharina, Fischer Katarzyna, Haapala Anna-Maija, Heijnen Ingmar, Herold Manfred, Klotz Werner, Kozmar Ana, Tesija Kuna Andrea, López Hoyos Marcos, Malkov Vladimir A, Musset Lucile, Nagy Eszter, Rönnelid Johan, Shoenfeld Yehuda, Sundic Tatjana, Tsirogianni Alexandra, Uibo Raivo, Rego Sousa Maria José, Damoiseaux Jan
Medical Faculty, Institute of Clinical Immunology, University Leipzig, Leipzig, Germany.
Clinical and Diagnostic Immunology, KU Leuven, Louvain, Belgium.
Auto Immun Highlights. 2020 Sep 3;11(1):12. doi: 10.1186/s13317-020-00134-0.
Special conditions associated with laboratory autoimmune testing are not well compatible with recent developments in regulatory frameworks such as EN/ISO 15189 accreditation or in vitro diagnostic medical device regulation (IVD-R). In addition, international recommendations, guidelines and disease criteria are poorly defined with respect to requirements on autoantibody testing. Laboratory specialists from Austria, Belgium, Croatia, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, and The Netherlands collected information, reported national experience, and identified quality issues in relation to autoantibody testing that require consensus on interpretation of the regulatory frameworks and guidelines. This process has been organized by the European Autoimmunity Standardisation Initiative (EASI). By identifying the critical items and looking for a consensus, our objective was to define a framework for, in particular, EN/ISO accreditation purposes. Here, we present a review of current publications and guidelines in this field to unify national guidelines and deliver in this way a European handout on quality control and accreditation for laboratories involved in autoantibody testing. We focus on quality items that can be checked during accreditation visits. Despite various local varieties, we encountered an overwhelming dedication to quality assurance in all contributing countries.
与实验室自身免疫检测相关的特殊情况与诸如EN/ISO 15189认可或体外诊断医疗器械法规（IVD-R）等监管框架的最新发展不太兼容。此外，关于自身抗体检测的要求，国际建议、指南和疾病标准的定义也很不完善。来自奥地利、比利时、克罗地亚、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、意大利、挪威、波兰、葡萄牙、南非、西班牙、瑞典、瑞士和荷兰的实验室专家收集了信息，报告了国家经验，并确定了与自身抗体检测相关的质量问题，这些问题需要就监管框架和指南的解释达成共识。这一过程由欧洲自身免疫标准化倡议（EASI）组织。通过确定关键项目并寻求共识，我们的目标是特别是为EN/ISO认可目的定义一个框架。在此，我们对该领域当前的出版物和指南进行综述，以统一国家指南，并以此方式为参与自身抗体检测的实验室提供一份关于质量控制和认可的欧洲手册。我们关注在认可访问期间可以检查的质量项目。尽管存在各种地方差异，但我们在所有参与国家都看到了对质量保证的高度重视。
