SA Pathology, Adelaide, SA, Australia; Royal Adelaide Hospital, Adelaide, SA, Australia.
Department of Clinical Immunology and Allergy, Royal Prince Alfred Hospital, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Pathology. 2021 Dec;53(7):883-888. doi: 10.1016/j.pathol.2021.01.018. Epub 2021 May 14.
Autoantibody assays are reported in a variety of formats. Results only slightly above established cut-offs provide lower likelihood ratios; therefore, their clinical significance may be more uncertain, which is not readily communicated with dichotomous qualitative reporting. Line immunoassays (LIA) are a common method for detecting antibodies to extractable nuclear antigens (ENA) and myositis-associated antibodies. However, recommended positive cut-offs are contentious. We distributed a survey via e-mail to participants in the Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP) Immunology modules and to a dedicated immunology mailing list in Australasia. Questions explored general viewpoints surrounding autoantibody reporting, as well as current laboratory practices, with particular focus on interpretation and reporting of the most commonly used ENA LIA manufactured by Euroimmun. There were 31 responders, representative of at least 17 unique laboratories across Australia (8 public, 5 private) and New Zealand (4 laboratories). Responses suggest that autoantibody reporting is not standardised; there was variation in general viewpoints and reporting practices, particularly regarding the interpretation of and positive cut-offs used for the Euroimmun ENA LIA, which were contrary to the manufacturer's guidelines in a majority of the responses. Interpretative qualitative reporting based on results from other investigations and the clinical history was a common theme. There is large variation in the reporting of autoantibody assays within Australasia, especially by LIA. A majority of respondents report the most commonly used ENA LIA contrary to manufacturer's guidelines; alternative positive cut-offs are commonly utilised. LIA reports should indicate the level of positivity to enhance their relevance in the clinical decision-making process.
自身抗体检测以多种形式报告。仅略高于既定临界值的结果提供较低的似然比；因此，其临床意义可能更不确定，这难以通过二分定性报告来传达。线免疫分析（LIA）是检测可提取核抗原（ENA）和肌炎相关抗体的常用方法。然而，推荐的阳性截断值存在争议。我们通过电子邮件向澳大利亚皇家病理学家学院质量保证计划（RCPAQAP）免疫模块的参与者以及澳大利亚的专门免疫学邮件列表分发了一份调查。问题探讨了围绕自身抗体报告的一般观点，以及当前的实验室实践，特别关注最常用于 Euroimmun 制造的最常用 ENA LIA 的解释和报告。有 31 名受访者，代表澳大利亚（8 个公共，5 个私人）和新西兰（4 个实验室）至少 17 个独特实验室。答复表明，自身抗体报告没有标准化；在一般观点和报告实践方面存在差异，特别是关于 Euroimmun ENA LIA 的解释和阳性截断值的使用，这些在大多数答复中与制造商的指南相悖。基于其他调查结果和临床病史的解释性定性报告是一个常见的主题。澳大利亚自身抗体检测的报告差异很大，特别是 LIA。大多数受访者报告最常用的 ENA LIA 与制造商的指南相悖；常用替代阳性截断值。LIA 报告应指出阳性程度，以增强其在临床决策过程中的相关性。
