Laboratory D-dimer measurement: Improved agreement between methods through calibration
Laboratory D-dimer measurement: Improved agreement between methods through calibration
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实验室 D-二聚体测量：通过校准提高方法之间的一致性
DOI：
10.1055/s-0037-1613742
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发表时间：
2007
影响因子：
6.7
通讯作者：
I. Walker
中科院分区：
文献类型：
--
作者：
I. Jennings;T. Woods;D. Kitchen;S. Kitchen;I. Walker
总结准确和精确的测量血浆D-二聚体水平是重要的诊断和治疗静脉血栓栓塞。然而，在多中心研究中报告了使用不同方法获得的D-二聚体结果的相当大的变异性。本研究探讨了在两个独立的多中心演习之间的实验室D-二聚体测量的精密度，以及通过使用校准曲线模型可以提高方法间的协议的程度。第一次试验表明，中心内精密度总体良好，82%的中心报告了两个相同但编码不同的样本的结果，彼此相差在10%以内。然而，6个中心报告的结果排除了一个样本的深静脉血栓形成（DVT），但未能排除另一个相同样本的DVT。在第二次练习中，当应用校准模型时，两个样本的D-二聚体结果的总体方法间精密度显着提高，使用所有参与者获得的三个“校准血浆”的共识中值重新计算D-二聚体值。对于以纤维蛋白原当量单位（FEU）报告结果的中心，两份样本的中心间变异系数（CV）分别从25.9%降至11.6%和22.4%降至7.7%。对于以ng/ml报告的中心，CV分别从45.3-21.6%和40.8- 11.6%下降。总之，通过校准模型和常用校准品血浆，可以通过不同方法改善D-二聚体结果的协调性。
Summary Accurate and precise measurement of plasma D-dimer levels is important in the diagnosis and management of venous thromboembolism. Considerable variability in D-dimer results obtained using different methods has, however, been reported in multicentre studies. This study explored in two separate multicentre exercises the degree of precision amongst laboratory D-dimer measurements, and the degree by which inter-method agreement could be improved using a calibration curve model. The first exercise demonstrated generally good within-centre precision, with 82% of the centres reporting results for two identical but differently coded samples within 10% of each other. However, six centres reported results which would have excluded deep vein thrombosis (DVT) for one sample but failed to exclude DVT for the other, identical sample. In the second exercise, overall between-method precision of D-dimer results for two samples was shown to improve markedly when a calibration model was applied, using the consensus median values obtained by all participants for three “calibration plasmas” to recalculate D-dimer values. For centres reporting results in fibrinogen equivalent units (FEUs),between-centre coefficients of variation (CVs) fell from 25.9% to 11.6% and 22.4% to 7.7%, respectively, for the two samples. For centres reporting in ng/ml, CVs fell from 45.3–21.6% and 40.8–11.6%,respectively. In conclusion, improved harmonisation of D-dimer results by different methods may be achieved by a calibration model and common calibrant plasmas.