Abstract：
Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate. Newer developments on ANA testing that offer novel features adopted by some clinical laboratories include automated computer-assisted diagnosis (CAD) systems and solid phase assays (SPA).
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.
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.
摘要：
目的：抗核抗体（ANA）对各种自身免疫性疾病的诊断具有重要意义。ANA通常通过使用HEp-2细胞(HEp-2IFA)的间接免疫荧光测定(IFA)来检测。影响HEp-2IFA结果的变量很多，比如主观视觉阅读，血清筛选稀释，基板制造,显微镜组件和共轭。ANA测试的最新发展提供了一些临床实验室采用的新颖功能，包括自动计算机辅助诊断（CAD）系统和固相测定（SPA）。
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。
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。
