A group of experts reviewed current literature and established recommendations on methodological aspects of ANA testing. This process was supported by a two round Delphi exercise. International expert groups that participated in this initiative included (i) the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group \"Autoimmunity Testing\"; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP).
In total, 35 recommendations/statements related to (i) ANA testing and reporting by HEp-2 IFA; (ii) HEp-2 IFA methodological aspects including substrate/conjugate selection and the application of CAD systems; (iii) quality assurance; (iv) HEp-2 IFA validation/verification approaches and (v) SPA were formulated. Globally, 95% of all submitted scores in the final Delphi round were above 6 (moderately agree, agree or strongly agree) and 85% above 7 (agree and strongly agree), indicating strong international support for the proposed recommendations.
These recommendations are an important step to achieve high quality ANA testing.
方法:一组专家回顾了当前的文献,并就ANA检测的方法学方面提出了建议。此过程得到了两轮Delphi练习的支持。参与该倡议的国际专家组包括(i)欧洲临床化学和实验室医学联合会(EFLM)工作组“自身免疫测试”;(ii)欧洲自身免疫标准化倡议(EASI);和(iii)ANA模式国际共识(ICAP)。
结果:总计,35个建议/声明涉及(i)HEp-2IFA的ANA测试和报告;(ii)HEp-2IFA方法学方面,包括底物/缀合物选择和CAD系统的应用;(iii)质量保证;(iv)制定HEp-2IFA验证/验证方法和(v)SPA。全球范围内,在最后一轮Delphi中,所有提交的分数中有95%高于6(适度同意,同意或强烈同意)和高于7的85%(同意并强烈同意),表明国际上对拟议建议的大力支持。
结论:这些建议是实现高质量ANA测试的重要步骤。