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The promise, perceptions, and pitfalls of immunoassays for autoantibody testing in myositis

机译:免疫测定在肌炎中的自身抗体检测的承诺,感知和陷阱

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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.
机译:现在可以在大多数肌炎患者中鉴定肌炎特异性自身抗体。它们识别均匀的患者亚组,并是开发个性化疾病管理方法的关键工具。在利用肌性炎性自身抗体作为生物标志物存在大量的临床兴趣,因此,已经开发了大量的商业测定以进行检测。这些测定已经普及临床使用。为了更好地了解来自国际肌炎界的感知问题,与这些分析的可靠性以及如何使用它们,我们对国际岩石专家进行了调查,所有这些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所提供的报告的分析类型,制造商和报告的性质的数据,并收到111个完整的回复。受访者还提供了有关他们如何使用不同的测定的信息,他们对结果的信心以及这影响他们的临床实践。酶免疫测定/ ELISA是全球使用的最受欢迎的测定方法,然后是线污染。线污染是欧洲最受欢迎的方法。尽管有超过80%的受访者对其实验室使用的测定有超过80%的受访者,但80%以上报告鉴定肌炎自身抗体影响其诊断信心,他们提供给患者的信息他们推荐的治疗。尽管关于结果的大多数用户的持续担忧,但是,使用商业免疫测定的肌炎特异性自身抗体测试在全球范围内使用,以通知临床决策。这些发现突出了对使用肌炎自身抗体测试的迫切指导的必要性以及对结果的解释。鉴于已经将已经放置在肌炎特异性自身抗体作为临床决策工具的重要性,对当前可用的测定的可靠性知识至关重要。

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