de Maat M P, Meijer P, Nieuwenhuizen W, Haverkate F, Kluft C
Gaubius Laboratory, TNO-PG, Leiden, The Netherlands.
Semin Thromb Hemost. 2000;26(6):625-30. doi: 10.1055/s-2000-13218.
D-dimer levels are used in clinical practice as markers for the presence or exclusion of venous thrombosis. Therefore, it is important that the performance of the D-dimer tests is well controlled. One of the components of a laboratory quality program is external quality assessment (EQA). The main aim of EQA is to identify the degree of agreement among laboratories. In addition to identifying the individual laboratory performance, it also identifies the characteristics of the different reagents and methods that are used in different laboratories. Recently, the D-dimer test was included in the ECAT External Quality Assessment program. Eighty-one laboratories in four rounds applied semiquantitative and quantitative D-dimer assays to three samples (concentrations normal, slightly elevated, and elevated). Although the reported values varied widely, the classification of the samples was mostly correct for the normal and the elevated samples. The slightly elevated sample was classified as normal by all laboratories using semiquantitative methods and by 60% of the laboratories using quantitative methods, and this varied between 45% and 86% for the different methods. In conclusion, D-dimer methods show a large variation, and the quality of the D-dimer assessment could be improved by standardization and by using cut-off ranges.
D - 二聚体水平在临床实践中用作存在或排除静脉血栓形成的标志物。因此，控制D - 二聚体检测的性能非常重要。实验室质量计划的组成部分之一是外部质量评估（EQA）。EQA的主要目的是确定各实验室之间的一致程度。除了确定单个实验室的性能外，它还能识别不同实验室使用的不同试剂和方法的特点。最近，D - 二聚体检测被纳入了ECAT外部质量评估计划。四轮测试中有81个实验室对三个样本（浓度正常、轻度升高和升高）应用了半定量和定量D - 二聚体检测方法。尽管报告的值差异很大，但对于正常样本和升高样本，样本的分类大多是正确的。所有使用半定量方法的实验室以及60%使用定量方法的实验室将轻度升高的样本分类为正常，不同方法之间这一比例在45%至86%之间变化。总之，D - 二聚体检测方法差异很大，通过标准化和使用临界值范围可以提高D - 二聚体评估的质量。
