Abstract：
The D-dimer is a sensitive indicator of coagulation and fibrinolysis activation, especially valuable as a biomarker of intravascular thrombosis. Measurement of plasma D-dimer levels plays a crucial role in the diagnosis and monitoring of conditions such as deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. A variety of immunoassays, including enzyme-linked immunosorbent assays, latex-enhanced immunoturbidimetric assays, whole-blood aggregation analysis, and immunochromatography assays, are widely used in clinical settings to determine D-dimer levels. However, the results obtained from different D-dimer assays vary significantly. These assays exhibit intra-method coefficients of variation ranging from 6.4% to 17.7%, and the measurement discrepancies among different assays can be as high as 20-fold. The accuracy and reliability of D-dimer testing cannot be guaranteed due to the lack of an internationally endorsed reference measurement system (including reference materials and reference measurement procedures), which may lead to misdiagnosis and underdiagnosis, limiting its full clinical application. In this review, we present an in-depth analysis of clinical D-dimer testing, summarizing the existing challenges, the current state of metrology, and progress towards harmonization. We also review the latest advancements in D-dimer detection techniques, which include mass spectrometry and electrochemical and optical immunoassays. By comparing the basic principles, the definition of the measurand, and analytical performance of these methods, we provide an outlook on the potential improvements in D-dimer clinical testing.
摘要：
D-二聚体是凝血和纤溶活性的敏感指标,作为血管内血栓形成的生物标志物尤其有价值。血浆D-二聚体水平的测定在深静脉血栓形成等疾病的诊断和监测中起着至关重要的作用。肺栓塞,和弥散性血管内凝血。各种免疫测定，包括酶联免疫吸附测定，乳胶增强免疫比浊法，全血聚集分析,和免疫层析分析，在临床中广泛用于确定D-二聚体水平。然而,从不同的D-二聚体测定获得的结果差异显著.这些检测方法内的变异系数在6.4%到17.7%之间，不同测定之间的测量差异可高达20倍。由于缺乏国际认可的参考测量系统（包括参考材料和参考测量程序），无法保证D-二聚体测试的准确性和可靠性，这可能会导致误诊和诊断不足，限制了其完整的临床应用。在这次审查中,我们对临床D-二聚体检测进行了深入分析，总结现有的挑战，计量学的当前状态，以及在协调方面的进展。我们还回顾了D-二聚体检测技术的最新进展，其中包括质谱和电化学和光学免疫测定。通过比较基本原理，被测量的定义，以及这些方法的分析性能，我们对D-二聚体临床试验的潜在改善进行了展望.
