Data from: International multicenter examination of MOG antibody assays.

Raw data set for: Reindl M, Schanda K, Woodhall M, Tea F, Ramanathan S, Sagen J, Fryer JP, Mills J, Teegen B, Mindorf S, Ritter N, Krummrei U, Stöcker W, Eggert J, Flanagan EP, Ramberger M, Hegen H, Rostasy K, Berger T, Leite MI, Palace J, Irani SR, Dale RC, Probst C, Probst M, Brilot F, Pittock SJ, Waters P. International multicenter examination of MOG antibody assays. Neurol Neuroimmunol Neuroinflamm. 2020 Mar 5;7(2). doi: 10.1212/NXI.0000000000000674. Print 2020 Mar 5. PubMed PMID: 32024795; PubMed Central PMCID: PMC7051197. Objective: To compare the reproducibility of 11 antibody assays for immunoglobulin (Ig) G and IgM myelin oligodendrocyte glycoprotein antibodies (MOG-IgG and MOG-IgM) from 5 international centers. Methods: The following samples were analyzed: MOG-IgG clearly positive sera (n = 39), MOG-IgG low positive sera (n = 39), borderline negative sera (n = 13), clearly negative sera (n = 40), and healthy blood donors (n = 30). As technical controls, 18 replicates (9 MOG-IgG positive and 9 negative) were included. All samples and controls were recoded, aliquoted, and distributed to the 5 testing centers, which performed the following antibody assays: 5 live and 1 fixed immunofluorescence cell-based assays (CBA-IF, 5 MOG-IgG, and 1 MOG-IgM), 3 live flow cytometry cell-based assays (CBA-FACS, all MOG-IgG), and 2 ELISAs (both MOG-IgG). Results: We found excellent agreement (96%) between the live CBAs for MOG-IgG for samples previously identified as clearly positive or negative from 4 different national testing centers. The agreement was lower with fixed CBA-IF (90%), and the ELISA showed no concordance with CBAs for detection of human MOG-IgG. All CBAs showed excellent interassay reproducibility. The agreement of MOG-IgG CBAs for borderline negative (77%) and particularly low positive (33%) samples was less good. Finally, most samples from healthy blood donors (97%) were negative for MOG-IgG in all CBAs. Conclusions: Live MOG-IgG CBAs showed excellent agreement for high positive and negative samples at 3 international testing centers. Low positive samples were more frequently discordant than in a similar comparison of aquaporin-4 antibody assays. Further research is needed to improve international standardization for clinical care.本数据集对应文献：Reindl M、Schanda K、Woodhall M、Tea F、Ramanathan S、Sagen J、Fryer JP、Mills J、Teegen B、Mindorf S、Ritter N、Krummrei U、Stöcker W、Eggert J、Flanagan EP、Ramberger M、Hegen H、Rostasy K、Berger T、Leite MI、Palace J、Irani SR、Dale RC、Probst C、Probst M、Brilot F、Pittock SJ、Waters P. 《抗髓鞘少突胶质细胞糖蛋白（myelin oligodendrocyte glycoprotein, MOG）抗体检测试剂盒的国际多中心评估》，发表于*Neurol Neuroimmunol Neuroinflamm* 2020年3月5日；第7卷第2期，DOI: 10.1212/NXI.0000000000000674，印刷版发表于2020年3月5日，PubMed PMID: 32024795；PubMed Central PMCID: PMC7051197。 研究目的：对比来自5个国际中心的11种抗免疫球蛋白G（immunoglobulin G, IgG）与免疫球蛋白M（immunoglobulin M, IgM）抗髓鞘少突胶质细胞糖蛋白抗体（MOG-IgG及MOG-IgM）检测试剂盒的重复性。 研究方法：本次分析纳入以下样本：明确MOG-IgG阳性血清（n=39）、低度MOG-IgG阳性血清（n=39）、临界阴性血清（n=13）、明确阴性血清（n=40）以及健康献血者样本（n=30）。另设置18份复现样本作为技术对照（其中9份为MOG-IgG阳性、9份为阴性）。所有样本与对照均经编码、分装后分发至5家检测中心，各中心采用以下抗体检测方案：5种活细胞免疫荧光法基于细胞的检测（cell-based immunofluorescence assay, CBA-IF，其中5种针对MOG-IgG、1种针对MOG-IgM）、3种活细胞流式细胞术基于细胞的检测（cell-based flow cytometry assay, CBA-FACS，均针对MOG-IgG）以及2种酶联免疫吸附试验（enzyme-linked immunosorbent assay, ELISA，均针对MOG-IgG）。 研究结果：来自4个国家检测中心的、经预先判定为明确阳性或阴性的样本，其MOG-IgG活细胞CBA检测结果一致性达96%。固定细胞CBA-IF检测的一致性稍低（90%），而ELISA检测与CBA检测在人源MOG-IgG的检测上无一致性。所有CBA检测均展现出优异的批间重复性。对于临界阴性样本（一致性77%），尤其是低度阳性样本（一致性33%），MOG-IgG CBA检测的结果一致性较差。最终，绝大多数健康献血者样本（97%）在所有CBA检测中均呈MOG-IgG阴性。 研究结论：活细胞MOG-IgG CBA检测在3家国际检测中心中，针对高阳性与阴性样本展现出优异的结果一致性。低度阳性样本的不一致率高于此前抗水通道蛋白4抗体检测的同类对比研究。未来仍需开展进一步研究以优化临床检测的国际标准化流程。