A Reference Material for Harmonisation of D-Dimer Assays
A Reference Material for Harmonisation of D-Dimer Assays
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用于协调 D-二聚体测定的参考材料
DOI：
10.1055/s-0038-1656098
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发表时间：
1997
影响因子：
6.7
通讯作者：
W. Nieuwenhuizen
中科院分区：
文献类型：
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作者：
W. Nieuwenhuizen
总结术语“D-二聚体测定”表明，这些测定报告了交联纤维蛋白的终末期降解产物的浓度。这在患者中几乎不会发生。交联纤维蛋白的降解产物以宽范围的分子量出现，并且包含各种数量的D-二聚体基序。此外，用不同的“D-二聚体”测定获得的数值变化很大。这些变化可能是由于与患者体内出现的各种含D-二聚体降解产物一起使用的各种单克隆抗体的反应性差异;以及具有生产商指定值的各种校准品。由于上述原因，严格意义上的校准品（例如纯D-二聚体）不可行。这项研究表明：为所研究的每种“D-二聚体”测定产生转换因子似乎是可行的，这将使得用这些试剂盒获得的广泛变化的结果是可比较的;转换因子可以基于真实的患者样品库;并且转换因子是不依赖于库的。本研究的下一步也是最后一步是准备和提供国际参考材料，供制造商和其他面临比较问题的人使用。这项工作正在与国家生物安全中心（P. Gaffney博士）合作进行，预计将于1997年初提供材料。
Summary The term “D-dimer assay” suggests, that these assays report the concentrations of the end-stage degradation product of crosslinked fibrin. This hardly occurs in patients. Degradation products of crosslinked fibrin rather occur with a wide range of molecular weights, and comprise various numbers of the D-dimer motif. Moreover, the numerical values obtained with different “D-dimer” assays vary widely. The variations are probably due to differences in reactivity of the various monoclonal antibodies used with the various D-dimer containing degradation products as they occur in patients; and to the various calibrators with a value assigned by the manufacturers. For the reasons indicated above a calibrator in the strict sense (e.g. pure D-dimer) is not feasible. This study shows that: it appears feasible to generate a conversion factor for each of the “D-dimer” assays studied, which will make the widely varying results obtained with these kits comparable; that the conversion factors can be based on a pool of real patient samples; and that the conversion factors are pool-independent. The next and final step in this study is to prepare and make available an international reference material for use by manufacturers and others facing a comparison problem. This is being carried out, in collaboration with the NIBSC (Dr. P. Gaffney), and the material is expected to be available in early 1997.