International multicenter examination of MOG antibody assays
International multicenter examination of MOG antibody assays
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DOI：
10.1212/nxi.0000000000000674
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发表时间：
2020-03-01
影响因子：
8.8
通讯作者：
Waters, Patrick
中科院分区：
文献类型：
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作者：
Reindl, Markus;Schanda, Kathrin;Waters, Patrick
目的比较国际5个中心11种髓鞘少突胶质细胞糖蛋白抗体（MOG-IgG和MOG-IgM）检测方法的重复性。方法对39例MOG-IgG明确阳性血清、39例MOG-IgG低阳性血清、13例临界阴性血清、40例明确阴性血清和30例健康献血员进行分析。作为技术对照，纳入18份重复样品（9份MOG-IgG阳性和9份阴性）。将所有样本和对照品重新编码、等分并分发至5个检测中心，由其进行以下抗体测定：5项基于活细胞和1项基于固定免疫荧光细胞的测定（CBA-IF、5项MOG-IgG和1项MOG-IgM）、3项基于活流式细胞术细胞的测定（CBA-FACS，均为MOG-IgG）和2项ELISA（均为MOG-IgG）。结果我们发现，从4个不同的国家检测中心获得的MOG-IgG的活CBA与先前确定为明确阳性或阴性的样本之间具有极好的一致性（96%）。与固定CBA-IF的一致性较低（90%），ELISA与CBAs检测人MOG-IgG不一致。所有CBA均表现出良好的批间重现性。MOG-IgG CBA对于临界阴性（77%）和特别低阳性（33%）样本的一致性较差。最后，来自健康献血者的大多数样本（97%）在所有CBA中对MOG-IgG呈阴性。结论3个国际检测中心的活MOG-IgG CBAs对高阳性和阴性样本的检测结果具有良好的一致性。与水通道蛋白-4抗体检测的类似比较相比，低阳性样本更经常出现不一致。需要进一步的研究来提高临床护理的国际标准化。
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.