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新 EUROLINE 神经系统综合症 15 Ag (IgG) 用于测定与神经系统疾病相关的自身抗体的性能评估。

Performance Assessment of the New EUROLINE Neurologic Syndrome 15 Ag (IgG) for the Determination of Autoantibodies Associated with Neurological Disorders.

发表日期:2024 Oct 08
作者: Iswariya Venkataraman, Anthonina Ott, Ramona Miske, Madeleine Scharf, Anette Schulz, Thomas Scheper, Wolfgang Meyer, Lars Komorowski
来源: NEUROLOGY

摘要:

在此,我们评估了新的 EUROLINE 神经系统综合症 15 Ag (IgG) 的性能,该药物通过添加 CDR2L(连同抗 Yo 靶向的 CDR2)、AK5 和 Neurochondrin (NCDN) 扩展了 EUROLINE 副肿瘤神经系统综合症 12 Ag。以及非副肿瘤性自身抗体(AAb)在过去十年中已被描述用于治疗神经系统疾病。通过将相关抗原整合到现有检测中,可以改善患者的诊断检查并减少诊断差距。使用总共 194 个临床和诊断预表征的样品分析了每种 AAb 的敏感性(表 1)。使用至少 100 份来自健康献血者的血清来研究每种 AAb 的特异性。使用 EUROLINE Neuroologic Syndrome 15 Ag,在 89-100% 的样本中确认了自身抗体阳性。特别是,临床和基于组织的间接免疫荧光测定预表征表明抗Yo阳性的所有样本均为抗CDR2和-CDR2L双阳性。血清和脑脊液 (CSF) 中抗 AK5 的检测灵敏度分别为 90% 和 100%,抗 NCDN 的灵敏度为 100%。个体特异性≥99%。该试剂盒是一种体外定性测定针对大量 15 种不同神经元自身抗原的 AAb 的工具,以支持神经系统综合征的诊断。抗 CDR2 和抗 CDR2L(均为抗 Yo)的并行检测增加了诊断意义,因为双阳性与副肿瘤性小脑变性密切相关。[表:见正文]。
Here, we assess the performance of the new EUROLINE Neurologic Syndrome 15 Ag (IgG) which expands the EUROLINE Paraneoplastic Neurologic Syndrome 12 Ag by adding CDR2L (together with CDR2 targeted by anti-Yo), AK5, and Neurochondrin (NCDN).Many paraneoplastic as well as non-paraneoplastic autoantibodies (AAbs) have been described in neurological disorders in the last decade. By integrating the associated antigens into existing assays, the diagnostic work-up of patients is being improved and diagnostic gaps reduced.Sensitivity of each AAb was analyzed using a total of 194 clinically and diagnostically pre-characterized samples (Table 1). Specificity of each AAb was investigated using a minimum of 100 sera from healthy blood donors.Using the EUROLINE Neurologic Syndrome 15 Ag, autoantibody positivity was confirmed in 89-100% of samples. In particular, all samples for which clinical and tissue-based indirect immunofluorescence assay pre-characterization indicated anti-Yo positivity were anti-CDR2 and -CDR2L double positive. Anti-AK5 was determined in serum and cerebrospinal fluid (CSF) with a sensitivity of 90 and 100%, respectively, and anti-NCDN with a sensitivity of 100%. The individual specificities were ≥99%.This kit is a tool for the qualitative in vitro determination of AAbs against a large panel of 15 different neuronal autoantigens to support the diagnosis of neurologic syndromes. The parallel detection of anti-CDR2 and anti-CDR2L (both anti-Yo) increases the diagnostic significance, as double positivity is strongly related to paraneoplastic cerebellar degeneration.[Table: see text].