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Standardization of the assay method for anti-A/B antibody titers and its problems

机译：抗A / B抗体滴度的测定方法的标准化及其问题

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Introduction of effective treatments such as (double filtration) plasmapheresis, splenectomy, intravenous immunoglobulin and potent immunosuppressive agents including anti-CD20 monoclonal antibody, has greatly improved graft outcome in ABO-incompatible transplantation. The measurement of anti-blood group A/B antibody titers is considered to be important, because it would provide useful information on prognosis and indication of transplantation, selection of treatments and prediction of acute rejection. Isohemagglutinin assay in serial-doubling dilutions of serum sample by tube test has been basically used in most institutions. However, detailed assay procedure seemed to vary between institutions. Furthermore, the determination by visual observation might cause a problem of inter-examiner variability. The Japanese ABO-Incompatible Transplantation Committee has conducted a series of nationwide surveys to assess the current status of inter-institutional variation in measurement of anti-A/B antibody titer. In the first survey, serum samples from 6 healthy volunteers with blood groups A (n=2), B (n=2) and O (n=2) were sent to 29 institutions where ABO-incompatible kidney or liver transplantation has been performed. Anti-A/B antibody titer was measured by its own protocol. Inter-institutional difference of measured values reached to 32-fold and 256-fold in IgM and IgG, respectively. As this variability was too wide for detailed analysis, the provisional standard protocol for the assay was determined according to the result of questionnaire survey. Next, 38 and 40 institutions participated in the second (in 2004) and the third survey (in 2005), respectively. Anti-A/B antibody titers of serum samples were measured by the standard procedure. Analysis of survey revealed that intra-institutional variation was reduced to below 8-fold (mostly 2- to 4-fold), although several institutions still needed some guidance. Standardization of the assay procedure and quality control survey would be necessary to improve the accuracy of measurement.Significance of measurement of anti-A/B antibody titer in ABO-incompatible transplantation should be discussed after the result of multi-center study is obtained.
机译：引入有效处理，如（双过滤）浆术，脾切除术，静脉内免疫球蛋白和有效免疫抑制剂，包括抗CD20单克隆抗体，在ABO不相容的移植中具有大大提高的移植结果。抗血液组A / B抗体滴度的测量被认为是重要的，因为它将提供有关预后和移植的指示的有用信息，治疗选择和急性排斥反应的预测。在大多数机构中基本上使用了Isohemagglutinin测定在血清样品的连续稀释稀释液中。但是，详细的测定程序似乎在机构之间变化。此外，目视观察的确定可能导致考试间变异性的问题。日本的Abo-Indompative移民委员会在全国范围内进行了一系列的调查，以评估抗A / B抗体滴度测量的机构间变异的现状。在第一次调查中，将来自6个健康志愿者的血清样本与血液组（n = 2），b（n = 2）和o（n = 2）发送到29个肾脏或肝移植的29个机构。通过其自身的方案测量抗A / B抗体滴度。分别在IgM和IgG中达到32倍和256倍的测量值的机构间差异。由于这种可变性太宽以进行详细分析，因此根据问卷调查结果确定了分析的临时标准议定书。接下来，38个和40个机构分别参加了第二次（2004年）和第三次调查（2005年）。通过标准程序测量血清样品的抗A / B抗体滴度。调查分析显示，体制内变化减少到8倍以下（主要是2至4倍），尽管若干机构仍然需要一些指导。对于提高测量的准确性，需要进行测定程序和质量控制调查的标准化。在获得多中心研究的结果之后，应讨论抗A / B抗体滴度测量的抗A / B抗体滴度。

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