University of Bath, Bath, UK.
Keio University, Tokyo, Japan.
Arthritis Res Ther. 2020 May 15;22(1):117. doi: 10.1186/s13075-020-02210-2.
A myositis-specific autoantibody can now be identified in the majority of patients with myositis. They identify homogeneous patient subgroups and are key tools in developing a personalized approach to disease management. There is substantial clinical interest in exploiting myositis autoantibodies as biomarkers, and consequently, a large number of commercial assays have been developed for their detection. These assays are already in widespread clinical use. In order to better understand perceived concerns from the international myositis community in relation to the reliability of these assays and how they are being used, we conducted a survey of international myositis experts, all of whom were members of the International Myositis Assessment and Clinical Studies group.
We collected data on the types of assay used, manufacturers, and the nature of the report provided by different laboratories and received 111 complete responses. Respondents also provided information on how they used the different assays, their confidence in the results, and how this influenced their clinical practice. Enzyme immunoassay/ELISA was the most popular assay method used worldwide followed by line blot. Line blot was the most popular method used in Europe. Despite concerns from over 80% of respondents regarding false-positive and false-negative results with the assay used by their laboratory, over 80% reported that the identification of a myositis autoantibody influenced their diagnostic confidence, the information they provided to a patient, and their recommended treatment.
In spite of ongoing concerns from the majority of users regarding the reliability of the results, myositis-specific autoantibody testing, using commercial immunoassays, is being used globally to inform clinical decision-making. These findings highlight the need for urgent guidance on the use of myositis autoantibody testing and on the interpretation of results. Knowledge of the reliability of currently available assays is essential given the importance already placed on myositis-specific autoantibodies as clinical decision-making tools.
现在可以在大多数肌炎患者中识别出肌炎特异性自身抗体。它们可以确定同质的患者亚组，是制定疾病管理个性化方法的关键工具。临床对肌炎自身抗体作为生物标志物的开发具有很大的兴趣，因此，已经开发出大量用于检测它们的商业检测方法。这些检测方法已经在广泛的临床应用中使用。为了更好地了解国际肌炎社区对这些检测方法的可靠性以及如何使用这些检测方法的看法，我们对国际肌炎专家进行了调查，他们都是国际肌炎评估和临床研究组的成员。
我们收集了不同实验室使用的检测方法类型、制造商以及报告的性质的数据，共收到 111 份完整的回复。受访者还提供了有关他们如何使用不同检测方法、对结果的信心以及这如何影响他们的临床实践的信息。酶免疫测定/ELISA 是全球最受欢迎的检测方法，其次是线印迹。线印迹是欧洲最受欢迎的方法。尽管超过 80%的受访者对他们实验室使用的检测方法存在假阳性和假阴性结果表示担忧，但超过 80%的人报告说，肌炎自身抗体的鉴定影响了他们的诊断信心、向患者提供的信息以及他们推荐的治疗方法。
尽管大多数用户对结果的可靠性持续存在担忧，但使用商业免疫测定法检测肌炎特异性自身抗体仍在全球范围内用于为临床决策提供信息。这些发现强调了迫切需要就肌炎自身抗体检测的使用和结果的解释提供指导。鉴于肌炎特异性自身抗体已经作为临床决策工具的重要性，了解当前可用检测方法的可靠性至关重要。
