Laboratory of Neuroimmunology, IRCCS Mondino Foundation, Via Mondino 2, I-27100 Pavia, Italy, Phone: 0039-0382-380365, Fax: 0039-0382-380286.
Laboratory of Neuroimmunology, IRCCS Mondino Foundation, University of Pavia, Pavia, Italy.
Clin Chem Lab Med. 2018 Oct 25;56(11):1921-1925. doi: 10.1515/cclm-2018-0234.
Background Anti-ganglioside antibodies are currently used in the differential diagnosis of suspected immune-mediated neuropathies. In-house and increasingly used commercial assays seem to perform suboptimally, and comparative information on their analytical performance are essentially lacking. Born within the frame of guidelines and standardization activities by the Italian Association of Neuroimmunology, this external quality assessment scheme (EQAS) is a real-life snapshot of the laboratory diagnostics in this field. Methods The EQAS consisted of five surplus, anonymized serum samples from patients with clinically-defined neuropathies and two serum samples from healthy blood donors. Eight laboratories used commercial line-/dot-blots, seven in-house/commercial ELISAs (in addition, 13 laboratories tested a recently released ELISA by Bühlmann). Only high anti-ganglioside antibody reactivities were considered, in accordance with consolidated recommendations. Results Large variations in anti-ganglioside antibody profiles were observed, even, although to a lesser extent, within homogeneous classes of assays. Concordance between the profiles and clinical phenotypes was also partial. Conclusions Although conducted on a relatively small, but representative number of Italian laboratories, this EQAS shows a critical between-laboratory disagreement in the test results of anti-ganglioside antibodies. Also considering the trend for using certified assays in generalist laboratories, strong efforts toward standardization and the identification of the best method(s) for their determinations are compellingly needed.
背景 抗神经节苷脂抗体目前用于疑似免疫介导性神经病的鉴别诊断。内部和越来越多使用的商业检测似乎表现不佳，关于它们的分析性能的比较信息基本缺乏。本外部质量评估计划（EQAS）是意大利神经免疫学会的指南和标准化活动的一部分，它真实反映了该领域的实验室诊断情况。
方法 EQAS 由五份来自临床定义的神经病患者的多余、匿名血清样本和两份来自健康献血者的血清样本组成。八个实验室使用商业线/斑点印迹法，七个使用内部/商业 ELISA（此外，13 个实验室测试了 Bühlmann 最近发布的 ELISA）。仅考虑与巩固建议一致的高抗神经节苷脂抗体反应性。
结果 即使在同种类型的检测中，也观察到抗神经节苷脂抗体谱存在很大差异。谱与临床表型之间的一致性也是部分的。
结论 尽管是在相对较小但具有代表性的意大利实验室中进行的，但这项 EQAS 表明在抗神经节苷脂抗体的测试结果中存在实验室间的严重分歧。考虑到在一般实验室中使用认证检测的趋势，强烈需要进行标准化和确定最佳方法的努力。
